DAY 1

AGENDA

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07.35 – 08.20
Registration

 

08.20 – 08.30
Welcome & Chairman’s Opening
Remarks for Day One

08.30 – 09.00

Digitalization, modeling, and machine learning: Pillars for development of next generation bioprocesses

  • 1. The talk will describe how MSD is strategizing the use of digitalization, modeling, and machine learning tools for development of next generation bioprocesses.
  • 2. The discussion would include the applicability and suitability of various tools relevant to data aggregation, modelling and simulation, as well as machine/deep learning.
  • 3. Relevant case studies in different areas of development and manufacturing (upstream and downstream) would be shared.
  • 4. Finally, Examples will be provided how the aforementioned techniques are being integrated with high throughput setups and PAT applications for speedy development and enhanced process understanding.

09.00 – 09.30

Insights on industrial manufacturing of allogeneic cell therapies

  • 2D cultivation of allogeneic cell therapies
  • Scale up technologies for 2D cultures
  • Challenges of industrial scale manufacturing in 2D
  • Next gen processes to overcome scale limitations

Downstream Development

09.30 – 10.00

 

The past, the present, and the future – continuous chromatography at Sanofi

  • Continuous chromatography can reduce resin costs by 70-95%
  • By exploiting resin lifetime, especially for early phase clinical projects, it is more environmentally friendly than traditional batch processes
  • Different business cases are compared with advantages and disadvantage for clinical manufacturing vs. commercial manufacturing
  • Implementation of continuous chromatography also comes with challenges during process transfer and for virus clearance studies

Upstream Sciences

09.30 – 10.00

 

Simple modeling methodologies for smart cell culture process development

  • Simplicity as a Strength: The talk will demonstrate how simple modeling techniques can provide powerful insights, support strategic decisions, and drive innovation across complex bioprocesses — because “the height of sophistication is simplicity.” – Clare Boothe Luce
  • From Cells to Manufacturing processes: diverse modeling applications ranging from clone selection and cell culture production performance to osmolality modeling and scale up & plant/economic evaluations will be presented
  • Bridging Understanding and Optimization: accessible models can reveal critical process dynamics, support predictive capabilities, and foster better cross-functional collaboration.

10.00 – 10.50
COFFEE BREAK & MEETINGS

10.50 – 11.40

Roundtable Discussions:

For 6 to 10 participants (per roundtable) to discuss and debate on a topic of their choice

  1. Next Gen Processes to Overcome Scale Limitations
  2. Late-Stage Development of Purification Processes for Biotherapeutics
  3. Digitalization, Modeling, and Machine Learning
  4. Laboratory Data Automation Experiences
  5. Lean Process Characterisation in Upstream Processing- Challenges and Experiences for Implementation
  6. HCP Control Strategy – Benchmarking and Common Understanding of Agency Requirements
  7. Challenges in Outsourcing CMC development
  8. ML/AI for Process Development
  9. DSP Intensification Strategies

 

11.40 –13.10

One to One Meetings & Investment Areas

  • Downstream/Upstream Process Technology Platforms
  • Biopharma 4.0
  • Digitalization
  • Specialised cell culture media
  • Single-use & Disposable Technologies
  • Separation and Purification Technology
  • Virus Filtration Processes
  • Smart Manufacturing Technologies – Tech. Transfer
  • Facility Management & Integration
  • Biopharma & Modular Biosafety Technology
  • Capacity & Facility Design
  • Multi product facilities
  • Fluid Management Systems
  • Lean/Operational Excellence
  • Continuous Improvement
  • PAT & MES, Automation and Process Control Excellence
  • QbD, Quality Assurance & Quality Systems
  • Validation Process/Life cycle Management systems
  • Regulation – Rapid Release Testing
  • cGMP – Contract, External Manufacturing Services
  • Biogenerics/Biobetters
  • Personalised Medicines
  • Cell & Gene Therapy
  • Fill and finish
  • Microbial Process Development and Production
  • Biopharmaceutical USP 665 Testing & Characterization Services

Workshops

11.40 – 12.10

 

Large-scale implementation data for Amsphere A+: a high DBC, low backpressure, 1M NaOH stable Protein A resin

  • Building on the proven platform of Amsphere A3, JSR Life Sciences has developed Amsphere A+, a next-generation Protein A resin designed to meet the evolving demands of the biopharma industry.
  • Combining high dynamic binding capacity even at short residence times with exceptional stability during repeated 1 M NaOH exposure and excellent pressure–flow performance, Amsphere A+ enables more efficient, robust operations.
  • In this presentation, we will share key large-scale performance and life-cycle data and demonstrate how Amsphere A+ serves as a versatile affinity platform for both classical and non-classical antibody formats, supporting high process intensification and enhanced in-process bioburden control.

12.10 – 12.40

 

Pharma 4.0 in Action: Unlocking the Value of Unified Life Sciences Eco-system

The pharmaceutical industry is embracing Pharma 4.0 and digital transformation to improve efficiency, compliance, and agility. This session explores how unified life sciences and MES solutions address disconnected systems, regulatory demands, and operational inefficiencies while fostering collaboration and continuous improvement.

  • Leverage unified manufacturing system to streamline operations, enhance compliance, and drive digital transformation in Pharma 4.0.
  • Overcome challenges related to disconnected systems, regulatory requirements, and operational inefficiencies through an integrated approach.
  • Foster cross-team collaboration to improve agility, meet evolving market demands, and establish a framework for continuous improvement.

    12.40 – 13.10

     

    Accelerating Bioprocessing with 3M™Harvest RC: A joint Implementation Success by Solventum and CDR-Life

    • In today´s dynamic biopharmaceutical environment, manufacturers face growing pressure to optimize upstream processing steps while maintaining product quality and regulatory compliance
    • One critical area is cell culture clarification – the removal of cells, cell debris, and soluble impurities from harvested cell culture fluid prior to downstream processing.
    • Solventum and CDR-Life successfully collaborated to rapidly implement the innovative chromatographic clarification solution that replaces conventional depth filtration methods. 3M™ Harvest RC Chromatographic Clarifier efficiently separates cells, cell debris and DNA from the harvested cell culture fluid containing the target product in a single-stage clarification step, utilizing Q-chemistry grafted nonwoven media.
    • The rapid adoption of 3M™Harvest RC in an established process environment was achieved significantly faster than typical technology changeovers.
    • Key benefits during implementation included significant time saving in the harvest phase, improved filtrate quality, reduced DNA levels, and a simplified clarification step.
    • Importantly, these gains were realized without requiring major changes to the existing equipment or process layout, highlighting the plug-and-play nature of the technology.

    13.10 – 14.00

    NETWORKING LUNCH

    Downstream Development

    Upstream Sciences

    14.00 – 14.30

    Investigations in virus filter process performance at different positions in the downstream process

    • The focus of authorities on contamination control strategy requires a re-assessment of the downstream process
    • New virus filters enable the filtration of higher concentrated samples and thus placement further downstream the purification process
    • Studies showed successful re-location of the filters, although flux was affected, depending on the molecule studied
    • Irrespective of low or high flux viral clearance studied an effective removal of viruses

    14.00 – 14.30

    Matching Medium and Process

    • Increase of volumetric productivity exceeds all initial expectations in the field
    • Fed-batch, intensified fed-batch and perfusion processes made it to the manufacturing
    • Both, medium and process contributed to the strong gain in volumetricproductivity
    • Media optimization tailers the medium to the specific process needs
    • Case studies for a perfusion medium will be presented and challenges discussed

    14.30 – 15.00

    Bioprocess Development for NK cells – understanding the effect of CCPs

    • Natural killer cells (NKs)
    • Cell therapy
    • Critical process parameter (CPP)
    • Cell expansion
    • Cytotoxicity

    14.30 – 15.00

    Scalable Harvest Solutions to New Challenges from Process Intensification

    • Upstream process intensification via n-1 perfusion reactor technologies can bring significant benefits and titer uplift to biologics
    • Increased output on upstream processes pose new challenges on downstream processing capacity and equipment
    • The deployment of single-use centrifuge can improve throughput, lower impurity burden, reduce waste and overall COGs
    • Pilot case study and real data for 1k, 2k bioreactor GMP

    15.00 – 15.30

    Bridging the Gap for BioPharma End-to-end Lab Automation Platform: Success and Opportunity

    • Microscale purification using Robocolumns in Tecan Liquid handlers
    • Automation of filtration applications to enable end to end purification platform
    • Leveraging multi attribute method testing to streamline Product quality assessment
    • Develop a framework for end-to-end automation platform for monoclonal antibody

    15.00 – 15.30

    There Is No Free Lunch: Building Advanced Analytics for Commercial Biomanufacturing

    • Advanced analytics as an enabler for biomanufacturing lifecycle management
    • Getting the right people for the right job
    • Getting to the data: building a fit-for-purpose data architecture
    • What is the data science playbook to overcome the sparsity of information in manufacturing datasets?
    • Moving from data to insights, and from insights to actions and results with a case study in commercial biomanufacturing

    15.30 – 16.20

    COFFEE BREAK & MEETINGS

    16.20 – 17.20

    One to One Meetings & Investment Areas

    • Downstream/Upstream Process Technology Platforms
    • Biopharma 4.0
    • Digitalization
    • Specialised cell culture media
    • Single-use & Disposable Technologies
    • Separation and Purification Technology
    • Virus Filtration Processes
    • Smart Manufacturing Technologies – Technology Transfer
    • Facility Management & Integration
    • Biopharma & Modular Biosafety Technology
    • Capacity & Facility Design
    • Multi product facilities
    • Fluid Management Systems
    • Lean/Transformational Change – Operational Excellence
    • Continuous Improvement / Manufacturing Processing
    • PAT & MES, Automation and Process Control Excellence
    • QbD
    • Quality Assurance & Quality Systems
    • Validation Process/Life cycle Management systems
    • Regulation – Rapid Release Testing
    • cGMP – Contract, External Manufacturing Services
    • Biogenerics/Biobetters
    • Personalised Medicines
    • Cell & Gene Therapy
    • Fill and finish
    • Microbial Process Development and Production
    • Biopharmaceutical USP 665 Testing & Characterization Services

    Workshops

    16.20 – 16.50

    From Molecule to Manufacturing: Unlocking Process Intensification Across the Biopharma Lifecycle

    • Molecular-level intensification: Leveraging high-titer, high-efficiency cell lines supported by advanced analytics, tailored media development, and cell banking services for both research and GMP production.
    • Upstream process intensification: Evaluating PI strategies in upstream processing based on key drivers such as process duration, volumetric productivity, cost of goods, and operational flexibility—tailored to the needs of different manufacturing models.
    • Downstream process intensification: Approaches to reduce cost of goods and facility footprint, comparing membrane-based and resin-based technologies, single vs. multi-column setups, and orchestration platforms for continuous DSP.

    16.50 – 17.20

    Process intensification, mRNA & precipitated mAb purification with disruptive Vibro® Membrane Filtration

    • Design behind the Vibro® Technology enabling outstanding performances and new opportunities compared to currently available filtration and centrifuge technologies
    • Low and uniform TMP, high concentration & viscosity enabling process intensification, continuous processes, simplification by removing process steps
    • Understand how Vibro® Membrane Filtration (VMF) is supporting sustainability with its extremely low energy consumption and environmental footprint
    • Case study 1: mRNA purification by SPTFF with 3-fold higher performances vs. specifically developed current technologies to handle mRNA
    • Case study 2: VMF is the only available technology enabling precipitated mAbs/proteins filtration by SPTFF as an alternative to high costly affinity columns both in batch and continuous processes

      17.20 – 17:50

      Innovative and Diversified Pipeline and its Potential

      • About BioNTech – true to the vision “science into survival”
      • Strategy and approach – synergy among diverse therapeutic modalities
      • Pipeline – updated priorities and focused programs

      17.50

      CHAIRPERSON’S CLOSING REMARKS AND END OF DAY ONE

      17.55

      Networking drinks reception

      Back to top

      DAY 2

      AGENDA

      08.10 – 08.15
      Welcome & Chairman’s Opening
      Remarks for Day Two

      08.15 – 08.45

      Efficiency Unleashed: Fully Automated Self-Optimizing Screening in Process Development

      • Downstream process development of biopharmaceuticals expressed in microbials and practical benefit of a process design platform.
      • SMART Process Design Platform, a user-friendly platform for Boehringer Ingelheim´s scientists and data scientists to host and utilize process models.
      • Model-Guided DoE Approach to enhance process development by intelligently suggesting experiments, leading to rapid improvements in model quality and predictive power.
      • Autonomous Process Optimization: the platform automates the experiment design, execution, and data analysis, significantly improving efficiency.
      • Iterative Model Training and Retraining showing how model quality increases with each iteration, ultimately reaching a plateau, and achieving higher outputs.
      • Genetic Algorithm for Optimization, applying the concept of survival of the fittest to create new generations of models, leading to convergence towards optimal solutions

      08.45 – 09.15

      Next generation checkpoint inhibitor; JJP-1008 for the treatment of cancer

      • Novel checkpoint inhibitor
      • Innovative cancer treatment
      • Biomarker for patient stratification
      • Immunosuppression versus immune-activation
      • Anti-CD270 (HVEM), JJP-1008 for the treatment of melanoma

      Downstream Development

      09.15 – 09.45

      DSP intensification strategies- Practical approaches to enhance throughput and reduce COGs in downstream processing

      • Upstream process intensification, such as high inoculation density (HID) and N-1 perfusion, significantly increases product titres but introduces downstream purification challenges like reduced filtration capacity, higher impurities, and capture step bottlenecks.
      • Downstream Process (DSP) intensification strategies focus on improving performance, reducing process time and footprint, and enabling continuous manufacturing through advancements in cell harvesting, Protein A capture resins, multi-column chromatography, polish step intensification, in-line buffer management, and single-pass TFF.
      • Case Study 1: Screening and optimizing high-capacity Protein A resins at reduced bed heights improved productivity and maintained product quality, addressing challenges from intensified upstream processes.
      • Case Study 2: Evaluation of two cation exchange chromatography resins demonstrated trade-offs between yield and purity, highlighting the need for intensified DSP to manage increased loads and enhance process robustness for monoclonal antibodies.

        Bioprocess Innovation

        09.15 – 09.45

        Modeling in biotherapeutics process development: Moving towards workflow integration

        • Modeling typically performed on project basis
        • Goal: Integrate modeling as standard tool in development workflows
        • Prerequisites for workflow integration
        • Case study presentation

          09.45 – 10.15

          Optimization of continuous capture chromatography

          • Development and optimization of continuous capture chromatography is more complex than for batch chromatography
          • Optimization of one parameter (e.g. load of one column) affects state of other parameters (e.g. pre-load on next column)
          • Iterative algorithms can be used for process optimization
          • Case study presented where productivity was increased by 50%

            09.45 – 10.15

            Intermediate Hold Time in mAb Processing

            • Significance of process intermediates stability
            • Control of intermediate stability
            • Pitfalls
            • Strategies for hold time studies

              10.15 – 11.00
              COFFEE BREAK & MEETINGS

              11.00 –11.50

              Roundtable Discussions:

              For 6 to 10 participants (per roundtable) to discuss and debate on a topic of their choice

              1. Potential and challenges of changes and optimizations as part of life cycle management of Biotherapeutics manufacturing
              2. Going to large scale with our process
              3. AI Adoption in the Laboratory
              4. Next Generation Process Improvements
              5. Approaches to Conducting CQA Assessment and its Application to Process Understanding
              6. ML/AI for Process Development
              7. Addressing Upstream Bioprocessing Complications
              8. Data Science and AI for CMC: Beyond the Hypee
              9. Challenges and Solutions in Tech Transfer

               

              11.50 – 13.20

              One to One Meetings & Investment Areas

              • Downstream/Upstream Process Technology Platforms
              • Biopharma 4.0
              • Digitalization
              • Specialised cell culture media
              • Single-use & Disposable Technologies
              • Separation and Purification Technology
              • Virus Filtration Processes
              • Smart Manufacturing Technologies – Technology Transfer
              • Facility Management & Integration
              • Biopharma & Modular Biosafety Technology
              • Capacity & Facility Design
              • Multi product facilities
              • Fluid Management Systems
              • Lean/Transformational Change – Operational Excellence
              • Continuous Improvement / Manufacturing Processing
              • PAT & MES, Automation and Process Control Excellence
              • QbD
              • Quality Assurance & Quality Systems
              • Validation Process/Life cycle Management systems
              • Regulation – Rapid Release Testing
              • cGMP – Contract, External Manufacturing Services
              • Biogenerics/Biobetters
              • Personalised Medicines
              • Cell & Gene Therapy
              • Fill and finish
              • Microbial Process Development and Production
              • Biopharmaceutical USP 665 Testing & Characterization Services

              Workshops

              11.50 – 12.20

              Biopharma Speed, Flexibility and Reliability enabled by Digital

              • Digital ambition: Delivering fast, flexible, and reliable PD and manufacturing operations
              • In Silico PD solutions that drive new entitlement of speed and robustness in process development
              • Automation solutions that reduce batch deviations and accelerate release
              • IoT solutions that drive significant reduction of unplanned downtime
              • PAT vision to enable advanced process controls

                12.20 –12.50

                Integrated mAb Capture and Polishing Steps Using the Octave™ MCC Platform

                • Continuous and semi-continuous bioprocessing is becoming more widely adopted in the biopharmaceutical industry, and Multi-column Chromatography (MCC) is playing a crucial role in the conversion.
                • The transition to a fully continuous process ideally fulfills the industry’s economic and environmental regulations, with incremental integration proving to be a practical solution for continuous biomanufacturing.
                • Tosoh Bioscience demonstrates this integration using its Octave™ MCC platform, which uses a Protein A capture step and subsequent polishing step to purify high-titer monoclonal antibody (mAb) feedstock.

                  12.50 –13.20

                  Streamlining Bioprocess Development: A Novel Perspective on the Role of Hybrid Models and Risk-Based Optimal Experimental Designs

                  • Leveraging a powerful combination of hybrid modeling, transfer learning, and Pareto-based Bayesian optimization to enhance process understanding, reuse historical data across products and scales, and enable risk-informed experimental design – accelerating development and process understanding.
                  • These technologies are incorporated and leveraged as part of the “methodology”, inspired by the PDCA (Plan-Do-Check-Act) cycle used in lean development, but which is adapted to the capabilities and opportunities of machine-learning.
                  • The result is increased efficiency, effectiveness, and flexibility across the product life cycle, with faster and more robust, insight-driven, decision-making. Case studies across multiple modalities will be discussed.

                    13.20 –14.10

                    NETWORKING LUNCH

                    Upstream Sciences/CMC Development

                    14.10 – 14.40

                    Revealing the temporal impact of dissolved oxygen on lactate metabolism in mammalian bioprocesses using dynamic design of experiments

                    • The switch from lactate production to consumption is crucial for mammalian bioprocesses but remains not fully understood.
                    • A robust switch to lactate consumption improves metabolic efficiency, cell growth, and productivity.
                    • Efforts focus on actively controlling and maintaining the lactate consumption state throughout the bioprocess.
                    • Dissolved oxygen (DO) is a critical process parameter significantly influencing lactate metabolism in CHO cells.
                    • The presented study investigates the impact of DO on lactate metabolism and its effect on overall process performance, considering exposure time and levels using dynamic design of experiments
                    • Insights aim to define a robust DO profile aligned with cellular dynamics and scalable bioprocesses

                      Bioprocess Innovation

                      14.10 – 14.40

                      DSP debottlenecking: Workflow to develop multicolumn capture step with improved cost of goods

                      • Drivers for the development of multicolumn capture step
                      • Development of multicolumn platform technology and optimization
                      • Consideration in scaling up of the multi column technology
                      • Conclusion and future outlook

                        14.40 –15.10

                        Early CMC: Shaping Success in Biopharmaceutical Development

                        • Strategic importance of early CMC (in research) in biopharmaceutical development lifecycle
                        • Role of early CMC in developability assessment, lead candidate selection, and project success
                        • Key activities in early CMC: expression system optimization, analytical method development, and initial process design
                        • Influence of early CMC strategies on formulation design and manufacturing platform choice
                        • Integration of early CMC with discovery research and clinical development for accelerated timelines and enhanced success probability

                          14.40 –15.10

                          Model-assisted development in antibody purification

                          • Limits of experiential process knowledge
                          • Holistic model utilization in downstream processing
                          • From candidate screening to facility fit
                          • Development acceleration and efficiency gains

                            15.10 – 15.40

                            AI-Powered Protein Design for Tomorrow’s Biologics

                            • Different backgrounds, shared mission: Bringing experience from enzyme development for small-molecule chemistry into the world of biologics manufacturing.
                            • The hidden tools powering bioprocessing: How microbial proteins like Protein A underpin antibody production, and why current limitations create bottlenecks.
                            • Enzyme renaissance through AI: Single-cell genomics and machine learning open access to new microbial proteins, from next-generation Fc binders to enzymes for ADC conjugation, glycan remodeling, and QC workflows.
                            • The vision: Co-developing tailored enzymes and ligands with the bioprocessing industry to enable faster, greener, more reliable biologics manufacturing.

                              15.40 – 16.10

                              COFFEE BREAK

                              16.10 – 16.40

                              Outsourced early CMC development of a non-platform protein: Experience dealing with CDMOs

                              • Overview of Tribune Therapeutics, a leading research company in fibrotic diseases
                              • Product portfolio including the frontrunner TRX-44, an albumin fusion protein
                              • Management of the CMC development using exclusively CDMOs towards initial clinical trial application
                              • What went well, what needs special attention, what needs to improve
                              • General learnings how to deal with CDMOs

                                16.40

                                CHAIRPERSON’S CLOSING REMARKS

                                16.45

                                CLOSE

                                Back to top

                                Please Note: Workshop, Agenda, Speakers and Participants can be subject to change

                                Henry Lin

                                Global Head, Cell Culture Process Development
                                Sanofi

                                Henry Lin is a 20+ years veteran in the biopharma industry with deep subject matter expertise in the upstream space as well broad CMC experience spanning pre-clinical to FIH to commercial. He is currently the Global Head of Cell Culture Process Development at Sanofi having responsibilities for all of upstream development in U.S. and France. Prior to Sanofi, Henry was an Executive Director in Biologics Process Development at Merck, Director of Cell Culture Development at Boehringer Ingelheim, and Principal Scientist at Amgen. Henry is a co-inventor on 10 patents and an author of 28 peer-reviewed publications. Henry received his PhD in biochemical engineering from Rice University and bachelor’s degree in bioengineering from UC San Diego.

                                Ionela Iliescu

                                Sr. Scientist
                                Amgen

                                Process Development Scientist at Biogen for 26 years. Coordinate purification development activities for antibodies, fusion proteins, and other types of biological therapeutics. Lead for purification strategy, process development for internal and external programs, process characterization, process validation activities and related global regulatory filings.

                                Spencer Monaco

                                Sr. Associate Scientist
                                Biogen

                                Spencer is an NCSU graduate with a B.S. in Polymer and Color Chemistry. His first job was working on the Biogen manufacturing floor alternating between upstream and downstream activities, until migrating into a development support role and expressing interest in upstream media development. He currently works with the cell culture development teams at Biogen, providing chemical expertise to investigations and new media formulation construction. As of 2024, Spencer has returned to NCSU to pursue a Masters in Polymer Chemistry exploring the possibility of bringing advances in polymer science into the media design space.

                                Abstract

                                Large scale media production presents various challenges to modern bio-pharmaceutical companies. Highly concentrated feed solutions must be constructed with extra care to ensure the solution remains viable throughout a campaign. A 5L small-scale model was designed to capture comparative mixing stress, temperature profiles, and exposure times to reliably replicate precipitation seen during a production run. The data from the scale down model was used to redesign the formulation and process parameters to produce a stable solution at all scales. In addition to automation parameters, floor operations were evaluated for gains in operational efficiency. Implementation of the observed process changes resulted in successful subsequent media preparation and confirmation of the scalable design.

                                Matthias Wiendahl

                                Principal Scientist
                                Novo Nordisk A/S

                                - Diploma in Biotechnology at Technical University Braunschweig, Germany
                                - PhD (Dr. Ing.) in Juergen Hubbuchs group at Research Center in Juelich, Germany
                                - 2007-2012: Development scientist at Novo Nordisk A/S, Denmark
                                - > 2012: Principal Scientist in Manufacturing Science and Technology department at Novo Nordisk Denmark

                                Abstract

                                Continuous capture chromatography is a chromatographic technique promising higher resin utilization, higher productivity and lower buffer consumption than traditional batch chromatography capture processes. The design of cSMB processes is more challenging than the design of batch processes because each chromatographic phase is influenced by the load from the previous phase and it is in turn influencing the subsequent phase. An iterative approach can be used to identify optimal conditions.

                                Our current process design approach is based on single column breakthrough curves and feeding the breakthrough data into a model. However, this concept leads to a sub-optimal process as it is based on a single loading flow rate, while effectively, flow rates and amounts in interconnected and parallel load phases can be different so using one flow rate only leads to sub-optimal processes.

                                We are presenting an approach where different flow rates and different breakthrough curves are used as model inputs together with pressure-flow dependencies for the resin of interest. Using the improved process design, significantly higher productivities were achieved than with the standard procedure. The effect was confirmed for a given in-house model process (mAb purification using Protein A affinity chromatography) where productivities could be increased by approximately 50% which has been confirmed at laboratory scale. The presented approach was also evaluated using mechanistic modelling. Finally, implications of the new cSMB design approach for large-scale manufacturing are discussed.  

                                Dr. Wenqin Ni

                                Senior Principal Scientist
                                Pfizer

                                I joined Pfizer in 2013. Currently, I am a Senior Principal Scientist in Pfizer and lead multiple analytical programs from early stage (before clinical study) to commercial approval. My expertise is focusing on analytical strategies such as process characterization and comparability studies. I successfully developed comparability strategies for multiple programs to support clinical or commercial material usage after manufacturing process changes. In addition, I am a key lead/member of analytical comparability expert group in Pfizer to review analytical comparability strategy for biologics. Before joining Pfizer, I received a Ph.D degree in Northeastern University focusing on characterization of post-translational modifications in biologics using LC/MS.

                                Abstract

                                During product development and the life cycle of commercial product, process changes are inevitable. Products manufactured using pre- and post- process changes are required to demonstrate comparability per ICH Q5E. A comparability study is a critical tool to ensure the “similarity” of product quality including efficacy, pharmacokinetics, safety and immunogenicity.
                                In this presentation, a phase appropriate risk assessment of process change will be introduced, followed by comparability strategy based on the risk assessment. Analytical comparability study tools will be discussed including the analytical comparability plan, comparability criteria, execution, data analysis and presentation. Furthermore, non-clinical and clinical comparability will be briefly discussed if there is any analytical difference which may impact product quality. Two comparability case studies will be presented. The first study is to support a new bioprocess to improve product quality and to facilitate larger scale manufacturing. The second one is to support the use of an early process stability study for establishing commercial shelf-life by leveraging the comparability study for an accelerated program. The agency feedback from multiple markets for the case studies will also be discussed.  

                                Kyle McHugh

                                Associate Director
                                Takeda Pharmaceuticals

                                Kyle McHugh received his PhD in Chemical and Biological Engineering from the University of Delaware on cell culture models of neurodegenerative disease. He worked in Upstream Biologics Process Development at Bristol Myers Squibb supporting commercial process development and process characterization for multiple therapeutic protein projects as well as high-throughput optimization, media development, and PAT advancement. Currently, Kyle is an Associate Director of Biotherapeutics Process Development at Takeda Pharmaceuticals in Lexington, MA supporting advancement of platform capabilities and multiple project modalities from FIH through late-stage development.

                                Abstract

                                Speed to clinic is critical to enable faster identification of successful early-stage drugs and subsequently faster BLA filing to commercialization. Here we discuss multiple levers to enable faster timelines to IND balancing prioritization of the timeline, business risk, and minimization of pre-investment. From a cell line perspective, strategic choice of source material for exploratory and GLP Tox studies allows for earlier delivery of representative material. Application of automation tools for screening clones and sampling bioreactors allows for more extensive screening and efficient process development. Data connectivity for automated capture and visualization of real-time offline and online process metrics helps to monitor ongoing runs, aggregate data for modelling, and streamline analysis for reports and regulatory submissions. Overall, we demonstrate significant improvements in speed, throughput, and automation for early-stage cell culture process development.

                                Angela Lewandowski

                                Sr. Director | GDPE (Global Downstream Dev/Pilot Plant/External Mfg)
                                Bristol Myers Squibb

                                Angela joined Bristol Myers Squibb in 2013, and over time has taken on increasing responsibilities. Angela and her team of 4 direct reports and 16 full-time employees are responsible for downstream process development for BMS’ growing biologics pipeline. Angela is currently doing a 6-month rotation, where she leads an additional team of 4 direct reports and 28 full-time employees responsible for process analytics. She has been the drug substance matrix lead since 2016 for a monoclonal antibody asset, from mid-stage through commercialization and life cycle management. She has driven several key strategic cross-functional initiatives. Prior to BMS, she worked for several years at Sanofi Genzyme and Regeneron Pharmaceuticals, and has a total of over 19 years of industrial experience. Angela holds M.S. and Ph.D. degrees in Chemical and Biomolecular Engineering from the University of Maryland, and a B.S. in Chemical Engineering from the University of Virginia.

                                Scott H. Altern

                                Senior Scientist
                                AbbVie

                                Scott H. Altern completed his PhD in Chemical Engineering at Rensselaer Polytechnic Institute (RPI) in Professor Steven Cramer's group (2023). His PhD research was centered on advancing the state-of-the-art in mechanistic modeling of preparative column chromatography and high-throughput process development. Currently, his role is at AbbVie in Worcester, MA where he focuses on mechanistic modeling of preparative chromatography, computational fluid dynamics, and molecular modeling to directly aid in process development. Scott is also highly involved in using high-throughput (HT) experimentation to expedite process development and model generation. Overall, Scott aims to transform industrial bioprocess development using automation and multiscale modeling.

                                Abstract

                                In this work, we employed HT instrumentation and multiscale modeling to support early-stage process development for two monoclonal antibodies (mAbs). These molecules had nearly the same isoelectric point but were found to behave differently in CEX. Both antibodies were screened for their dynamic binding capacity (DBC) on POROS XS RoboColumns across a wide range of loading pH and conductivity. Curiously, opposing DBC trends with loading pH and conductivity were observed between the mAbs. Generally, increasing loading pH and conductivity, beyond a certain threshold, results in a reduced DBC in CEX systems. This was consistent with the behavior for mAb B, but contradicted the trends seen for mAb A. Molecular modeling was then employed to identify the molecular features responsible for the unusual screening results. Homology models were constructed for each of the antibodies, from which molecular descriptors were calculated. Descriptors such as net charge and CDR positive charge surface area were correlated with DBC values to confirm that the degree of exclusion was directly related to molecular charge properties. Additionally, mechanistic model parameters were regressed from RoboColumn breakthrough curves to provide additional insight into the unique chromatographic behavior. For instance, trends in surface diffusivity with loading conductivity and pH were examined to determine their contribution to CEX loading performance. Further experimental studies were conducted in order to elucidate the molecular origins of the observed trends. Dynamic light scattering (DLS) experiments were carried out to determine the protein-protein interaction constant over a range of pH and conductivity. Interaction strength was found to be correlated with DBC, suggesting that repulsive forces negatively affect DBC and are dependent on solution conditions. In summary, this study used high-throughput screening and multiscale modeling in conjunction to facilitate CEX PD and improve process understanding from a molecular perspective. 

                                Daryl Powers, Ph.D.

                                Director, Bioprocess Technology Manufacturing, Science and Technology
                                Bristol Myers Squibb

                                Daryl is a director in the Bristol Myers Squibb MS&T drug substance group. He leads a team of process subject matter experts and laboratory scientists supporting the BMS commercial and registrational biologics portfolio. He has a PhD in chemical engineering and 18 years experience in the biotechnology industry.
                                 
                                Abstract
                                A commercial process was experiencing significant yield and product quality variability. To enhance process SME insights, the enterprise invested in a substantial modelling effort, which included building a data pipeline and conducting both non-proprietary and proprietary process modelling efforts. Initial observations confirmed SME insights and provided quantified targets for future batches. The work for this project highlighted opportunities to improve data quality through addition of PAT tools, expanded data sources, and incorporation of more mechanistic features into models.

                                Dhanuka Wasalathanthri

                                Associate Director
                                Bristol Myers Squibb

                                Dhanuka Wasalathanthri, Ph.D. is an Associate Director at Bristol Myers Squibb (BMS) where his main role is to serve as the strategy lead for Process Analytical Technology (PAT), High-Throughput Automation and Digital Capabilities at Analytical Development organization. He is a versatile leader with more than 10 years of biotech industry experience in strategic implementation of technologies, CMC analytical development, project management and building high-performing teams in meeting corporate goals. Dhanuka represents BMS at several academic and industry consortia, and he Holds a Ph.D. in Analytical Chemistry from University of Connecticut, USA.

                                Abstract

                                Biopharmaceutical landscape is getting increasing complex with a broad spectrum of modalities to meet unmet medical needs, while external geo-political, regulatory, generic competition and sustainability challenges demand acceleration of drug development pipelines. Despite significant advancements in the development and manufacturing workflows for faster and more efficient processes such as intensified and continuous operations, in-process analytical testing is still mainly centric around manual testing. Harnessing the power of automation enables fit-for-purpose and plug-and-play modular units with end-to-end parallel testing of multiple analytical assays with significant improvement in speed and productivity. The concept of robotic process automation (RPA) tools resembles as “Digital Workers” to automatically process, analyze and transcribe analytical results in real time which greatly improves the rapid availability of data to the stakeholders. Complex modalities in the pipeline often require non-platform analytical methods, unique approaches, and upfront investment on method development. Such efforts can be greatly simplified using data interrogation techniques such as Machine Learning and Deep Learning approaches. Herein a vision, roadmap and case studies of automation and digital transformation efforts measured against main KPI’s such as speed and productivity for in-process analytics for biologics are presented.

                                Shyam Panjwani

                                Principal Data Scientist
                                Bayer Pharmaceuticals

                                Shyam Panjwani is currently working as a Principal Data Scientist at Bayer Pharmaceuticals, Berkeley. He holds a PhD degree from University of Houston and a bachelor’s degree from Indian Institute of Technology, Kanpur in chemical engineering. He has 8+ of experience in applying AI/ML/statistics for biologics manufacturing processes, biological assays and process development. Before joining Bayer, he worked with Halliburton and Air Products.

                                Abstract

                                The biopharmaceutical industry is increasingly turning to data science to optimize manufacturing processes and enhance product quality. This presentation explores two innovative case studies that leverage data science to improve efficiency in biologics manufacturing.

                                The first case study focuses on a cloud-based predictive modeling application designed to enhance the predictability of mammalian cell culture processes. By forecasting bioreactor potency from at-line process parameters over a multiple-day horizon, this application quantifies prediction uncertainty and provides valuable insights for process control, ultimately enhancing productivity and product quality.

                                The second case study presents a novel framework for assessing the out-of-specification (OOS) risk associated with drug product potency. This framework utilizes a cloud-based statistical software application to streamline the evaluation of alternate potency targets, reducing manual errors and improving the efficiency of risk assessments.

                                Together, these case studies illustrate the transformative impact of data science on the biopharmaceutical manufacturing landscape. 

                                Sandra Bennun

                                Director Biologics Process Development, BPR&D
                                Merck

                                Experienced R&D Director with a demonstrated history of evaluating and delivering Process Analytics and Automation solutions to clinical and commercial biologics manufacturing.

                                Carrie has been with Lonza for 17 years. Her focus at Lonza includes commercial biomanufacturing SME support and technology transfer of clinical to commercial manufacturing. She has been a key contributor to the Lonza R&D efforts in intensified, continuous mAb manufacturing. Her current role is leading a multidisciplinary team in the investigation and development of novel bioprocessing modalities with a focus on process analytical technologies. Recently she was in charge of the design and build of a stand alone state of the art facility for the research of novel technology and automation. The Process Innovation Center was completed in March 2024. As the Head of the PIC, Carrie is responsible for directing PAT and Automation research, Industry and Academic collaborations in the New England Biotech Ecosystem.

                                She has over 25 years in industry primarily focused on development of chromatography and separations technology with associated analytical method development. She is a member of numerous industry consortia and collaborative efforts with the intent to drive forward innovations to advance the current biomanufacturing processes.

                                 

                                Carrie Mason 

                                Associate Director Bioprocess R&D
                                Lonza

                                Experienced R&D Director with a demonstrated history of evaluating and delivering Process Analytics and Automation solutions to clinical and commercial biologics manufacturing.

                                Carrie has been with Lonza for 17 years. Her focus at Lonza includes commercial biomanufacturing SME support and technology transfer of clinical to commercial manufacturing. She has been a key contributor to the Lonza R&D efforts in intensified, continuous mAb manufacturing. Her current role is leading a multidisciplinary team in the investigation and development of novel bioprocessing modalities with a focus on process analytical technologies. Recently she was in charge of the design and build of a stand alone state of the art facility for the research of novel technology and automation. The Process Innovation Center was completed in March 2024. As the Head of the PIC, Carrie is responsible for directing PAT and Automation research, Industry and Academic collaborations in the New England Biotech Ecosystem.

                                She has over 25 years in industry primarily focused on development of chromatography and separations technology with associated analytical method development. She is a member of numerous industry consortia and collaborative efforts with the intent to drive forward innovations to advance the current biomanufacturing processes.

                                 

                                Shuangping Shi

                                Associate Vice President, Head of Biologics Process Research & Development
                                Merck

                                Experienced pharma leader with extensive knowledge in biologics CMC, small molecule CMC, commercial manufacturing, bioanalytics, GLP lab management and GMP manufacturing facility operation.

                                 

                                Brandon Moore

                                Senior Cell Culture Engineer II
                                Biogen

                                Brandon Moore is an Upstream Process Engineer with 13 years of experience working on the development, characterization, and optimization of mammalian cell culture biomanufacturing processes with a specific focus on advanced process control and process analytics. Throughout this work, a recurring theme that has surfaced is the need for new approaches towards improving process understanding using advanced modelling and troubleshooting techniques which take the unique complexities and performance of cell-based systems into account.

                                Abstract

                                Variability was observed in the cell culture performance of inoculum stages in batches of a large-scale HEK293 commercial therapeutic protein production process. The impact was significant enough in result in termination of several batches, as insufficient cell mass was present to inoculate subsequent stages. Root cause analysis and bench-scale laboratory studies indicated that the large-scale media preparations were the root cause of the growth impact, and that the magnitude of impact varied between media bottles within a batch. Additionally, variability was observed between multiple batches of media which used identical filtration and preparation operations.

                                The investigation summarized in this case study examined each step of the media preparation and filtration processes. Bottle-to-bottle variability in media performance was replicated under laboratory conditions when using a specific 0.1µm polyethersulfone (PES) pre-filter which was part of the filtration platform for Chinese hamster ovary (CHO) processes. Interestingly, the first few bottles of media filtered were found to support normal growth—performance impact was first observed in later bottles, becoming more severe before eventually resolving. This behavior is inconsistent with the widely-held assumption that the magnitude of process impact would be greatest in the first volume of media passing through a filter. Replacing the filter was found to result in restoration of consistently high cell growth in the previously-impacted inoculum stages. This case study highlights the importance of the robust evaluation of filtration schemes between media formulations for different cell lines and the strategic application of platform process elements.

                                Alexandre Super

                                Lead Statistician CMC Development
                                UCB

                                Alexandre currently works within the Centre of Expertise CMC Statistics at UCB Pharma. He is responsible the development and implementation of statistical and modelling approaches for biologics and medical devices projects throughout their lifecycle, from the early stages of technical development all the way to commercial manufacturing.

                                Yiannis Dres

                                Process Engineer, Clinical Manufacturing
                                Pfizer

                                Alessandra Molinaro is a Process Engineer with six years of experience in the biopharmaceutical industry specializing in cell culture operations at the clinical scale. Alessandra has a Bachelor of Science in purification at the clinical-scale and GMP Manufacturing. Yianni has a Bachelor of Science in Chemical Engineering from University of Massachusetts Lowell and a Master of Science in Biotechnology from Worcester Polytechnic Institute.

                                Abstract

                                Implementation of a new technology in a GMP manufacturing environment present several distinct challenges, including adhering to regulatory requirements, implementing new methods into the existing systems, as well as management of new risks. In this work, we present a case study of the implementation of the One-Pot Capture Redox (OPCR), a novel technology for the production of multispecifics, into a clinical production facility.

                                This presentation will discuss the challenges of introducing the OPCR technology at the clinical manufacturing scale. Based on the success of implementation of the new technology, a harmonized approach has been identified to enable other new technologies to be implemented simpler in GMP manufacturing.

                                Alessandra Molinaro

                                Process Engineer, Clinical Manufacturing
                                Pfizer

                                Alessandra Molinaro is a Process Engineer with six years of experience in the biopharmaceutical industry specializing in cell culture operations at the clinical scale. Alessandra has a Bachelor of Science in Chemical Engineering from the University of Massachusetts Lowell and a Master of Science in Biotechnology from Worcester Polytechnic Institute.

                                Abstract

                                Implementation of a new technology in a GMP manufacturing environment present several distinct challenges, including adhering to regulatory requirements, implementing new methods into the existing systems, as well as management of new risks. In this work, we present a case study of the implementation of the One-Pot Capture Redox (OPCR), a novel technology for the production of multispecifics, into a clinical production facility.

                                This presentation will discuss the challenges of introducing the OPCR technology at the clinical manufacturing scale. Based on the success of implementation of the new technology, a harmonized approach has been identified to enable other new technologies to be implemented simpler in GMP manufacturing.

                                Jian Ren

                                Principal Scientist, Bioprocess Development
                                Abbvie

                                Jian Ren is a Principal Scientist in the Manufacturing Science and Technology (MSAT) organization at AbbVie Bioresearch Center in Worcester, MA. She leads process tech transfer, validation, and manufacturing support activities for the downstream manufacturing process for late phase and commercial biologics programs, including monoclonal antibodies, bispecific antibodies and fusion proteins. Prior to MSAT, she led purification process development, tech transfer, and validation activities for early-to-late-phase biologics projects. Prior to AbbVie, her research focused on the development and optimization of polymeric membranes and modules for various separation applications. Jian holds a PhD in Chemical Engineering from the University of Connecticut.

                                Lihua Yang

                                Senior Principal Research Scientist
                                Abbvie

                                Dr. Lihua Yang has been at AbbVie for over 20 years and is currently a Senior Principal Research Scientist and Group Leader within the Purification Development Department in Product Development Science and Technology organization. Dr. Yang led 25+ early and late phase programs and numerous innovation initiatives on biologics in areas of mAb, bispecific, antibody-drug conjugates and gene therapy. She has extensive experience in bioprocess development, characterization, validation, tech transfer to global GMP manufacture, process internalization, product launch, IND and BLA filing. Besides leading strong functional and cross-functional teams to deliver innovative and improved purification process, Dr. Yang is also a subject matter expert in bioanalytical assay development and protein characterization. Dr. Yang holds a Ph.D degree in Chemistry and Chemical Biology from Northeastern University, and a BS degree in Physical Chemistry from Peking University in China.

                                Tom Ransohoff

                                OPERATING PARTNER
                                Keensight Capital

                                With over 35 years of professional experience in the biopharma industry, his experience includes serving as the Technical Head of the biologicals franchise within Resilience, overseeing all activities related to recombinant protein and monoclonal antibody projects and technology development initiatives.

                                Prior to that, Tom has held various C-suite positions at other biopharma companies such as 4th Dimension Bioprocess, Inc. (co-founder and COO), BioFlash Partners (President and CEO), TranXenGen, Inc. (Vice President, Operations), Dyax Corp (Vice President, Program Management and Product Development).

                                Tom is a regular speaker at leading biopharma conferences, has published over 20 academic articles and has also developed and filed several patents, related to innovative biopharma manufacturing processes.

                                Tom holds a B.S in Chemical Engineering from MIT and a M.S. in Chemical Engineering from the University of California, Berkeley.

                                Ishaan Shandil

                                Director, MS&T Process Modeling and Analytical Technologies
                                Bristol Myers Squibb

                                Ishaan Shandil is a Biochemical Engineer with 16 years of process and product development, manufacturing and project leadership experience in the Biopharmaceutical industry. Ishaan currently works as an Associate Director Process Engineering MSAT Bristol-Myers Squibb (BMS) where he is responsible for leading projects in Process Engineering and Manufacturing Technology functions. In his role at BMS, he also manages the technical aspects of an external manufacturing relationship and provides CMO oversight. Prior to joining BMS, Ishaan worked for Merck & Co. in roles spanning across R&D and Manufacturing where he designed and developed scalable bioprocesses to manufacture differentiated biologics drug candidates. He also studied and published the impact of process conditions on Glycosylation in monoclonal antibodies and fusion proteins. Ishaan received a MS in Chemical & Biochemical Engineering from University of California Irvine and an MBA from University of Chicago Booth School of Business.

                                Ravi Vattepu

                                Senior Scientist Pivotal Biologics Drug Substance Technologies
                                Amgen

                                Ravi Vattepu is a Senior Scientist in the Pivotal Biologics Process Development group, focused on purification process development of biologics. He holds a PhD in Chemistry from Wichita State University and completed postdoctoral research at Harvard Medical School, where his work focused on antibody glycosylation and the role of IgG subclasses in inflammation.