Agenda

Day one
Day two

DAY ONE

07.45 – 08.30

Registration

08.30 – 08.40

Welcome & Chairman’s Opening Remarks for Day One

08.40 – 09.25

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.

09.25 – 09.55

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.

09.55 – 10.25

High Resolution Accurate Mass Spectrometry: A Catalyst for Biomanufacturing Process Development

  • 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.”

10.30 – 11.20

COFFEE BREAK & MEETINGS

11.20 – 12.10

Roundtable Discussions

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

1. Future Directions for Accelerated Upstream Bioprocessing
2. Next Generation Downstream Processing
3. Process Intensification, Automation, Data Analytics, and PAT
4. Digitalisation and Automation for Acceleration of Bioprocess Development
5. Enhancing Productivity and Performance with Next-Generation Technologies
6. Best Practices In CMC Development And Effective Technology Transfer
7. Sustainability in Biopharma

 

12.10 – 13.40 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
  • Chromatography
  • 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

12.10 – 12.40

How new affinity resins can address growing complexities in downstream protein purification.

  • Application data will be presented on the capture of several Fc containing proteins using Praesto Jetted A50 HipH, a novel protein A resin with mild pH elution capability.
  • Discussion will focus on improvements of both purity and recovery under increased pH elution conditions.
  • Lastly, methods to improve process economy through high capacity and increased resin lifetime for purification of human bispecifics and Fab-based molecules will be explored for Praesto 70 CH1.

12.40 – 13.10

From Discovery to the Rentschler Biopharma Manufacturing Center (RBMC)

  • Client/CDMO partnership framework
  • Reliability in the production of complex biopharmaceuticals
  • Rentschler Biopharma, Milford: From single-product to multi-product…and into the future!
  • Scientific capabilities and expertise (molecules, bioreactors, and processes)
  • ONE Rentschler

13.10 – 13.40

Modular Platforms: Accelerating Biologics Deployment

  • Market Trends Continue Challenging Delivery of Therapies to Patients
  • Capital Expenditures need to be “Fit for Purpose” today but Pre-Engineered for future Ready.
  • Industry Shifts towards Modular Pre-Engineered Platforms for Rapid Delivery of High Value Biologics
  • Modular Platform Model: Lessons Learned Moving Forward to Realize Maximum Benefits

 

 

13.40 – 14.30

NETWORKING LUNCH

Downstream Processing

14.30 – 15.00

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.

 

Upstream Processing

14.30 – 15.00

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

15.00 – 15.30

Continuous Bioprocessing: Creating the next-generation UF/DF

  • We developed a novel one-step process for continuous ultrafiltration (UF) and buffer exchange, eliminating the traditional two-step UF/diafiltration (DF) operations.
  • Demonstrated mAb productivity 75% reduction in buffer consumption
  • Single-pass buffer exchange, and salt removal using the commercially available hollow-fiber
  • A natural successor to current state-of-the-art UFDF technologies for biologicals

15.00 – 15.30

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?

15.30 – 16.00

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.

15.30 – 16.00

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.

 

16.00 – 16.50

COFFEE BREAK & MEETINGS

16.50 – 17.50 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
  • Chromatography
  • 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

16.50 – 17.20

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

  • VMF: Unveiling new opportunities for upstream & downstream processes
  • Novel cell retention device: Achieving higher cell density and reducing membrane fouling
  • Streamlining processes by eliminating steps such as centrifugation and high-speed separation
  • Commitment to sustainable development and production, including a 90% reduction in energy consumption.

17.20 – 17.50

A Multi-Column Chromatography Proof of Concept: Consistent Performance in Multi-Column Chromatography and Scale-up

  • While MCC is known to dramatically increase productivity and decrease operating costs, practical implementation concerns remain, including consistency over the purification process.
  • We demonstrate that mAb and mAb-fragment capture MCC can achieve recovery, product quality, and purity that has low variability across both cycles and elutions and is comparable to single column chromatography.
  • MCC rapidly reuses multiple smaller columns over numerous cycles, while the equivalent process and load volume in single column mode would have comparatively few cycles. Concerns exist not just about overall performance comparability between single column and MCC, but also if MCC is able to maintain performance over the entirety of the run.
  • We present lab scale data that demonstrates that, after basic process development, 1) MCC maintains performance at the cycle level up to 50 cycles for mAb ProA capture and 2) individual elutions are consistent over the 15 individual elutions evaluated and comparable to batch for fAb ProL capture. In addition, we present a proof of concept demonstrating successful scale-up to a ~250 L process volume, which was performed in collaboration with our CDMO partner, Catalent.

 

Downstream Processing

Upstream Processing

17.50 – 18.20

Process Intensification Technologies Using In-line concentrators for High Titer mAb processes

  • As mAb titers are increasing, it is straining downstream purification manufacturing. One of the issues facing manufacturing is the ever increasing in-process volumes.
  • This study provides a comparative evaluation of Single Pass Tangential flow filtration (SPTFF) or In-line product concentrators technologies and there management of in-process volumes for downstream manufacturing process fit.
  • Comparative evaluation of SPTFF technologies including process robustness and controlling parameters, product quality impact, manufacturing scalability and implementation is discussed.

17.50 – 18.20

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.

 18.20 – 18.50

CT Manufacturing and AI

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

 

 

 

 

18.50

CHAIRPERSON’S CLOSING REMARKS AND END OF DAY ONE

18.55

Networking drinks reception

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DAY TWO

08.25 – 08.30

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

08.30 – 09.00

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)

09.00 – 09.30

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

  • Discuss what Industry 4.0 means for cell culture process development
  • Case Study 1: Combining a high-throughput automated cell culture DoE with fit-for-purpose process analytics
  • Case Study 2: Hybrid model prediction of process performance and product quality
  • Putting it all together to accelerate cell culture process development

 

09.30 – 10.00

Innovative analytical strategies for addressing common problems for new molecular format CMC development focusing on BLA: Process Characterization (Drug Substance)

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

 

Bioprocess Innovation

10.00 – 10.30

Smart Data Analytics for Fault Detection and Its Application to Biopharmaceutical Manufacturing

  • Process data analytics
  • Fault Detection
  • Automated Framework
  • Continuous monoclonal antibody testbed case study

 

CMC Development/Technology Innovation

10.00 – 10.30

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

10.30 – 10.55

COFFEE BREAK & MEETINGS

11.00 – 11.45

Roundtable Discussions

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

  1. Future Directions for Accelerated Upstream Bioprocessing
  2. Next Generation Downstream Processing
  3. Process Intensification, Automation, Data Analytics, and PAT
  4. Digitalisation and Automation for Acceleration of Bioprocess Development
  5. Enhancing Productivity and Performance with Next-Generation Technologies
  6. Best Practices In CMC Development And Effective Technology Transfer
  7. Sustainability in Biopharma

11.45 – 13.15 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
  • Chromatography
  • 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

11.45 – 12.15

Freeze Failure: Stop the Loss, Control Your Biologics’ Quality!

How can modular and yet universal freezing technologies improve product quality of your drug substances during cold chain logistics?

  • Discover possibilities to avoid product loss and sustain best possible product quality with controlled freezing solutions
  • Learn how far scalable freezing can go in a manufacturing environment through a case study
  • Understand indications of a successful freeze/thaw cycle and cryopreservation

 

 

12.15 – 12.45

Enabling Flexible Manufacturing with High Productivity Protein A Membrane up to 2000 L Scale

  • An intensified and fully single use downstream operation was demonstrated to process a monoclonal antibody cell culture harvest at a manufacturing scale.
  • The results of the study were extrapolated to show the potential for high productivity affinity capture sufficient up to 10 g/L titers at the 2000 L scale.

 

12.45 – 13.15

Beyond Modular Design-Build Construction: Customizing the Digital QC Lab

  • Just as vital as determining how to construct a cGMP accredited facility—whether a Modular or Stick-built architecture—is a forward-thinking plan that considers functionality within the validated state.
  • Most facilities are restricted by the real estate they are given, and thus it is crucial that their space programming plan considers Process Design, Qualification, and Sustained Verification long before the facility is commissioned.
  • A large part of that is designing clean environments to accommodate SOPs.
  • But a glaring void in the Design-Build sector remains, where service providers fail to offer and integrate the latest IoT solutions to monitor, store, and analyze critical data.
  • The evolution of Design-Build Construction is guiding clients into the direction of the Digital QC Lab, the “paperless state,” where building cleanrooms is simply the first phase of an ongoing Validation and Sustainability program.

 

 

 

13.15 – 14.05

NETWORKING LUNCH

Bioprocess Innovation

14.05 – 14.35

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

 

CMC Development/Technology Innovation

14.05 – 14.35

Smart CMC: Concepts and strategies

  • What is smart CMC
  • Importance of CMC governance
  • CMC is a process
  • CMC is phase appropriate

 

14.35 – 15.05

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

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

14.35 – 15.05

Advanced Technology-Transfer Strategies for GMP manufacturing of Biologics Drug Substances

  • 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.

15.05 – 15.35

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.

15.35 – 15.55

COFFEE BREAK

15.55 – 16.25

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

16.25

CHAIRPERSON’S CLOSING REMARKS

16.30

CLOSE

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