07.30 – 08.00

Registration

08.00 – 08.10

Welcome & Chairman’s Opening Remarks for Day One

08.10 – 08.40

JJP-1212 as example for the “SMART GOOSE” story

Autoantigen-specific IgA autoantibodies closely correlate with symptoms severity in a subgroup of patients in multiple autoimmune diseases. Beyond the value of these IgA autoantibodies as biomarkers, the presence of excessive IgA/autoantigen immune complexes results in continuous CD89 (Fc?RI)-mediated activation of myeloid cells, leading to severe tissue damage. Activation of myeloid cells – especially of neutrophils – is a highly underappreciated and untargeted hallmark of autoimmune diseases. Enabling a personalized medicine approach, high autoantigen-specific IgA serum levels will serve as companion diagnostic to stratify patients for personalized treatment with our antagonist humanized anti-CD89 antibody (JJP-1212). Interfering with the IgA/CD89 axis by JJP-1212, resolves IgA/autoantigen-induced inflammation and subsequent tissue damage in a variety of autoimmune diseases.

Louis Boon, JJP Biologics

08.40 – 09.10

Next Generation Manufacturing and Continuous Bioprocessing: application of rapid bioburden testing

  • In this work we focus on the evaluation and testing of a rapid bioburden technology and
    its implementation for Intensified and continuous bioprocessing (ICB) microbial control.
  • This technology allows detect contamination in hours instead of several days – a limitation
    of compendial methods.
  • The speed of detection is crucial to identify contamination and still have time to decide
    on material diversion for a continuous process.
  • In collaboration with NIIMBL colleagues, the strategy on how to use early detection of
    bioburden contamination, in a few ICB locations, informs how GMP facilities and their Quality
    Management System will need to include new mitigation strategies for product diversion and
    consequently batch release.
  • A case-study developed at AstraZeneca will be presented, where sampling strategy and
    real-time data analysis was crucial to inform bioburden levels for all process intermediates
    throughout the run.

Irina Ramos, Director Downstream Continuous Manufacturing, Bioprocess Engineering & Technology Group, AstraZeneca

09.10 – 09.40

Improving the Biomanufacturing Process with Accurate Mass Spectrometry

  • A review of various methods and instrumentation, including the benefits and limitations for each in biomanufacturing.
  • Top methods used in manufacturing setting for applications such as: Identification and sequencing of API, Host Cell Proteins, Impurities and Modifications of API, and Biosimilars.
  • Regulatory views, including description of use/acceptance at each phase of drug discovery from pre-clinical through BLA.
  • Future goals for multi-attribute monitoring, software compliance and standardization of practice.

Abby Gelb, Manager of Biologics Mass Spectrometry, SGS

Downstream Processing

09.40 – 10.10

Acceleration of downstream process development of both platform and non-platform molecules by adopting a HTS (High Throughput Screening) DoE approach using an automated 96 well HTS platform.

  • HTS can be used to rapidly develop downstream processes for molecules with a poor platform or no platform fit, so that we can choose the best molecule rather than eliminate it due to platform fit considerations.
  • With the right types of controls, yield and some impurity data from 96well seperations can be closely approximated to what is observed in traditional scale-down packed be chromatography.
  • Regeneron’s HTS platform greatly accelerates the development of early-stage clinical processes allowing for a “speed-to-clinic” approach.
  • HTS screening can be used to accelerate mechanistic model development to potentially replace scaled-down packed DoE’s.

 

James Reilly, Associate Director, Downstream Process Development, Regeneron

CMC Development/New Modalities

09.40 – 10.10

PAT to facilitate monitoring and control of biologics continuous manufacturing

  • Significance of continuous manufacturing in biologics
  • Importance of timely monitoring and process control in biologics continuous manufacturing
  • PAT toolbox for supporting biologics continuous manufacturing
  • PAT implementation cases in monitoring and control of biologics continuous manufacturing in Merck

Boyong Wan, Associate Principal Scientist,  Merck

10.10 – 11.00

COFFEE BREAK & MEETINGS

11.00 – 11. 30

Roundtable Discussions

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

1. Accelerating upstream process development – robust, scalable and reproducible process
2. Next Generation Downstream Processing
3. Process Intensification, Automation, Data Analytics, and PAT to Enable Continuous Processing and Biopharma 4.0
4. Bioprocess Innovation for New Modalities
5. Digitalisation and Automation for Acceleration of Bioprocess Development
6. Integration of Process Analytical Technologies in Upstream and Downstream
7. Best Practices In CMC Development And Effective Technology Transfer

 

11.30 – 13.00 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

11.30 – 12.00

Filling the gap between Downstream & Fill-Finish with scalable single-use technologies

  • The advantages of bags over bottles for primary packaging
  • Eliminate manual processes during substance filling
  • Benefits of controlled plate-freezers for your product quality

                                                                                  

12.00 – 12.30

Biopharmaceutical manufacturing – accelerating the path from concept to market (to patient)

  • The last decade has seen a rapid transition in therapeutical formats:from small molecules to large biological molecules
  • The increase in the degree of complexity is mirrored by the rise in
    druggable targets and promising discoveries
  • Many promising therapeutic approaches fail to reach the patient, although showing great potential in early discovery
  • To enable complex solutions, one must master these complexities in manufacturing at every step: tech transfer, process development, cMP production, right through to regulatory approval.
  • To tackle today’s key challenge a holistic approach is needed that streamlines a therapeutic’s path from concept to market to patient
  • 12.30 – 13.00

    Bioprocess Walk-Up Solution – let the system work for you!

    • Improve process understanding and develop more robust
      bioprocesses with a streamlined integrated analytical solution
    • Reduce costly delays and eliminate human errors with automated sample preparation and data transfer
    • Automate routine product quality and spent media analyses to simplify and accelerate your bioprocess development

     

    13.00 – 13.50

    NETWORKING LUNCH

    Downstream Processing

    13.50 – 14.20

    Process Characterization and Control Strategy Platform Development

    • Accelerated clinical process development and CMC timeline
    • Downstream process characterization workflow and case study
    • Leverage prior knowledge to simplify process characterization design
    • Approach on downstream Tier 1 and Tier 2 process characterization to enable PPQ and BLA
    • Control strategy platform development for robust manufacturing
    • Modelling consideration on future process characterization

    Lihua Yang, Senior Principal Research Scientist, AbbVie

    Upstream Processing

    13.50 – 14.20

    Transforming traditional cell culture process development with insilico solutions

    • Establishing a generic insilico model for cell culture processes.
    • The impact of generic models on cell culture productivity and quality over multiple programs.
    • Can Insilico modelling significantly improve process development over traditional approaches?
    • What gains can we achieve by applying insilico modelling to early or late-stage programs?

    Dr. Sarwat Khattak, Head of Cell Culture and Cell Line Development, Biogen

    14.20 – 14.50

    Development of Process Analytical Technologies for Downstream Processing in Commercial Biologics Production

    • Examples of PAT application in DSP manufacturing process
    • Benefits and challenges of inline measurements and controls in GMP production.

    Ujwal Patil, Associate Director Continuous Downstream/Next Gen Manufacturing, AstraZeneca


     

    14.20 – 14.50

    PAT in Upstream Processes – Fantastic as Development Tool and When to Use in Manufacturing

    • Examples of PAT tools used in USP development and transfer
    • Raman spectroscopy for generic plattform-wide prediction models
    • Biocapacitance for precise CSPR control in N-1 perfusion development
    • Multidimensional Fluorescence spectroscopy in media preparation
    • Online measurement of oxygen uptake rates to support clone selection
    • When should PAT move from development to manufacturing

    Delia Lyons, Principal Scientist, Abbvie

     

    14.50 – 15.20

    Leveraging Non-platform Tools to Control HMW During the Purification of a Bi-specific DVD Protein

    • The DVD protein is a poorly behaved molecule during downstream purification.
    • Tight %HMW spec was set at BDI stage, in order to achieve target purity in final BDS post conjugation.
    • Non-platform purification options, such as harvest RC filter, CEX conditions and UF/DF screens were evaluated to achieve HMW control.
    • Process successfully transferred to 500 L pilot scale.

    Lei Cao, Principal Scientist Purification Development, Abbvie


     

    14.50 – 15.20

    Application of Digital Modelling in New Product Introduction (NPI) into Commercial Facility

    • Digital modeling has been used to de-risk and facilitate successful NPI activities.
    • Case studies of using CFD and cell culture digital twin modeling will be presented.
    • Modeling provides recommendations on equipment and control strategies.
    • This helps to reduce at-scale tests and achieve the right first time tech transfer/scale up.

    Yuanyuan Cui, Principal Engineer, Sanofi

     

    15.20 – 16.10

    COFFEE BREAK & MEETINGS

    16.10 – 17.10 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 – 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

    16.10 – 16.40

    Double the yield of perfusion processes: Process intensification & simplification with Vibro® Membrane Filtration (VMF)

    • VMF – Revealing new opportunities for upstream & downstream processes
    • Novel cell retention device – Higher cell density, less membrane fouling
    • Eliminate process steps such as centrifugation, high speed separator
    • Sustainable development and production – 90% reduced energy consumption

    16.40 – 17.10

    How to Address GMP Annex 1 Requirements Implementing Single-Use Assemblies for Final Fill

    • Single-use systems in final filling: effects on efficiency and scalability
    • Significant updates in the New Annex 1 and their expectations regarding the use and control of single-use systems
    • Annex 1 and final fill single use systems: synergy for greater compliance
    • How molded closed single-use systems can reduce the risk of contamination, enhance efficiency, and ensure safety and quality

     

    17.10 – 17.40

    CSL112 Process Characterization Part II: implementation of a robust process control strategy
     

    • Implementing QbD principles for a plasma-derived biotherapeutic product
    • Applying a risk- and science-based approach leading to the identification of process parameters and material attributes potentially impacting quality and performance attributes
    • Outcome of process characterization leading to final classification of process parameters and material attributes
    • Case studies for the assessment of critical material attributes
    • Thorough process understanding leading to a robust process control strategy

    Madlene von Känel, Senior Manager Bioprocess R&D, CSL Behring

     

     

    17.10 – 17.40

    Design of Experiments and Modelling for Process Characterisation Studies

    • DoE as a tool to optimise process characterisation studies
    • Points of attention for the statistical analysis plan
    • Acceptance criteria to define CPPs/PARs
    • Case study from upstream process development

    Alexandre Super, Statistician CMC Development, UCB Pharma

    17.40 – 18.10

    Insights into Platform Purification Process Evolution

    • Using initial capture as an example, look at current landscape of purification options available and how to evaluate
    • Consider if non Protein A option(s) may be useful to integrate into a DSP development toolbox
    • Making effective use of process and cost models, within DSP development, to support decision making
    • Impact of covid pandemic on purification development

    Sanjay Nilapwar, Principal Scientist/Group Leader, Abbvie

    17.40 – 18.10

    Understand Manufacturing Costs, Impact on Yield and Sustainability of Single-use Technologies in Bioprocesses by Modelling

    • In this presentation we will examine the impact of process intensification on sustainability and cost saving opportunities and yield improvements through advanced material solutions.
    • Advanced material-based technologies offer the ability to intensify processes by enabling faster mass transfer, being able to operate in a broader range of conditions and deal with a diverse range of particle sizes.
    • In a case study we will compare advanced single-use technologies with more traditional approaches and show the impact on cost savings and sustainability.

     18.15 – 18. 50

    CT Manufacturing and AI
     

  • CMC is bottleneck for Cell Therapies
  • Manufacturing platforms are being developed
  • What can be the role of AI
  •  

    Oliver Hesse, VP & Head of Biotech Data Science & Digitalization, Bayer

     

     

     

    18.50

    CHAIRPERSON’S CLOSING REMARKS AND END OF DAY ONE

    18.55

    Networking drinks reception

    08.15 – 08.20

    CHAIRPERSON’S OPENING REMARKS FOR DAY TWO AND SUMMARY OF DAY ONE

    08.20 – 08.50

    Evolutionary pressure: advancement of bioprocessing platforms in a diverse pipeline environment

    • Platform intent and defining the approach a platform can take (ex: ranging from single process run identically for each asset to high level standardized approaches to development, early vs late stage application, etc)
    • Benefits of platforms, but also potential down sides of over-defining
    • Overview of Takeda’s unique pipeline and the balance we have struck on platform establishment and application (includes case studies)
    • Platform evolution and incorporation of new technologies: how to evaluate and decide, when and how to introduce, successes and pitfalls (includes case studies)

    Olga Paley, Director, Head mAb Derived Biologics Process Development,Takeda

    08.50 – 09.20

    Transforming Cell Culture Process Development with Industry 4.0: Integrating automated screening and hybrid modelling approaches to jump start process development

    • Data analytics are usually presented as the data power brought by digital to process understanding or development.
    • This technology significantly impacts processes once deployed and pretty often, driven through large projects, very few but experts understand what it would change in their direct environment.
    • This presentation will highlight not only the power of the technology, but how it may actually impact your professional life in so many diverse activities, day after day.

    Eric Hodgman, Scientific Director, Bristol Myers Squibb

     

    Bioprocess Innovation

    09.25 – 09.55

    Inline Buffer Formulation (IBF) – Lonza’s Experience

    • Inline Buffer Formulation (IBF) Systems are versatile with on demand formulation and dilution capabilities.
    • IBF systems can maintain a target formulation temperature while also controlling to a target pH and/or conductivity. The system can also control formulation using flowrate alone.
    • When applied to maximize benefits, significant reductions in plastic waste, process equipment, facility footprint, and resources required can be achieved.
    • Real world output of 2x – 4x protein production using ~50% of footprint when compared to a traditional facility.
    • Inline pH measurement/control accuracy in some scenarios has proven challenging and alternate control options have been identified.

    Matthew Macknight, MSAT Manager, Lonza Biologics

    Tech Transfer

    09.25 – 09.55

    Smart CMC: Accelerating time to clinic and market

    • What is smart CMC
    • Platforming early-stage development
    • De-risking scale-up and manufacturing
    • Late-stage optimization
    • concurrent validation strategies and BLA

    Siddhartha Srivastava, Vice President, Head of CMC and Global Technical Operations, Cue Biopharma
     

     

    09.55 – 10.25

    Digital Strategy In Action: Building Strong Foundations

    • Developing a clear, aligned strategy
    • Change is constant – will you be reactive or proactive?
    • Prioritizing big and small projects
    • Managing with limited resources
    • Recognizing and celebrating success

    Michael O’Connor, Senior Manager, BioProcess R&D Digital Program, Pfizer

     

    09.55 – 10.25

    Innovative analytical strategies for addressing common problems for new molecular format CMC development  

    Complex next generation biological molecules are becoming increasingly prevalent in today’s biopharmaceutical manufacturing landscape. Such molecules present unique challenges, due to their complex structures and heterogeneity, when compared with traditional antibody formats. Through case studies, this presentation will highlight innovative analytical strategies for addressing common problems during product development such as chain assembly, multiple-MoAs and diverse post-translational modifications

     

    Ian Anderson, Global Senior Principal Scientist, Lonza

     

    10.25 – 10.50

    COFFEE BREAK & MEETINGS

    10.50 – 11.35

    Roundtable Discussions

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

    1. Accelerating upstream process development – robust, scalable and reproducible process
    2. Next Generation Downstream Processing
    3. Process Intensification, Automation, Data Analytics, and PAT to Enable Continuous Processing and Biopharma 4.0
    4. Bioprocess Innovation for New Modalities
    5. Digitalisation and Automation for Acceleration of Bioprocess Development
    6. Integration of Process Analytical Technologies in Upstream and Downstream
    7. Best Practices In CMC Development And Effective Technology Transfer

    11.35 – 13.05 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

    11.35 – 12.05

    Optimizing Harvest and Recovery with Single Step Depth Filtration

    • Filter and diatomaceous earth selection
    • High throughput screening at 20ml sample size
    • Scalability from 0.1L to 2,000L+
    • Scale-up for pilot and production

    12.05 – 12.35

    Advances in Protein A Chromatography Resins

    • Jetting technology is a continuous emulsification technology by which all Praesto® chromatography resins are produced.
    • This proprietary technology results in resins with a narrow, almost uniform particle size distribution, with excellent mass transfer properties.
    • Herein, we present advances which utilize Jetting technology, including process intensification models and a novel Protein A resin designed specifically for elution of Fc-containing molecules at higher pH levels.

    12.35 – 13.05

    Viral Clearance in Cell & Gene Therapy – What if the Product is a Virus?

    • Assuring viral safety in cell and gene therapy (CGT) products poses a unique challenge as the viral vector is a key component of both in vivo and ex vivo gene therapies
    • Regulatory authorities expect the viral safety and contamination controls for CGT manufacturing to be assured through the application of a comprehensive program of material sourcing, virus testing at appropriate stages of manufacturing, and removal and/or inactivation of adventitious viruses and helper viruses by the manufacturing process (the ‘three pillars’ approach).
    • Material source is key when it comes to viral safety in cell and gene therapy products
    • A look at the challenges, considerations, and potential solutions for viral clearance in the field of cell and gene therapy

    13.05 – 13.55

    NETWORKING LUNCH

    Bioprocess Innovation

    13.55 – 14.25

    Micro-scale Purification Platform – Highthroughput tool for BioPharma Manufacturing Investigations

    • Process characterization
    • Justification of process and microbial control
    • Hold time studies
    • Reprocessing

    Manoj Ganesh, Senior Staff Process Scientist, Regeneron

    CMC Development/New Modalities

    13.55 – 14.25

    Beyond Antibodies – A Transformation

    • Transformation from antibody development to developing cell and gene therapies
    • Increasing complexity from new modalities
    • Reagents to support cell and gene therapy projects
    • Case-study: Developing a plasmid DNA process

    14.25 – 14.55

    Decoding the metabolic regulations that govern metabolic shift to lactate consumption in CHO fedbatch processes: The role of TXNIP

    • Lactate shift in CHO cell fedbatch processes is elusive in nature – mechanism governing it yet to be deciphered fully
    • We previously demonstrated TXNIP expression to be correlated with propensity of metabolic shift and identified several factors that induce TXNIP in CHO fedbatch processes
    • This talk will go over recent findings to establish TXNIP role in metabolic shift using genetic engineering approaches.

    Madeleine Rafa, Senior Scientist, Pfizer

    14.25 – 14.55

    From Development Through to Tech Transfer: Bridging latest High Throughput instrumentation with Legacy Instrumentation

    • Current industry challenges in clinical GMP tech-transfers across modalities.
    • Development of tech-transfer workflow as a business process from process development to pilot and pilot to clinical GMP manufacturing.
    • Generation of process and modality specific process transfer protocols.
    • Transition to complete digital tech-transfers.

    Rajat Sharma, Staff Engineer, Biotherapeutics process development, Takeda

    15.00 – 15.20

    COFFEE BREAK

    15.20 – 15.50

    Accelerating the Development of New Molecular Formats: Speed to Clinic

    • Outlining the most pressing challenges of analytical development of novel molecular biologic formats.
    • Highlighting how some of these key challenges can be addressed with example case studies.
    • Providing an overview of how an end-to-end integrated drug substance and drug product CMC strategy can be used to accelerate the path of a novel molecules to IND.

    Anasuya Dilaver, Lead Scientist, Lonza 

    15.50 – 16.20

    Open Panel Discussion: Current Bioprocess Innovation Trends for more efficient bioprocessing

    • Improvement in process economics in upstream and downstream processing
    • Redefining and simplifying biologics manufacturing process to efficiently capture contaminants and enhance productivity and performance with next-generation technology
    • Development and deployment of AI and Automation for process development for improved management of data and easier and better insight into process data
    • The evolution of biomanufacturing talent
    • Sustainability in Biopharma – from challenges to opportunities

    16.20

    CHAIRPERSON’S CLOSING REMARKS

    16.25

    CLOSE

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