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08:30 09:00 (30 mins)

ADC - Chemistry, Production and Manufacturing

Registration

09:00 09:10 (10 mins)

ADC - Chemistry, Production and Manufacturing

Chairperson's Opening Remarks

  • Sanjay Nilapwar - Purification Process Scientist, Medimmune, USA

09:10 09:50 (40 mins)

ADC - Chemistry, Production and Manufacturing

Cost-effective clinical manufacturing of antibody drug conjugates in multi-purpose facilities

Antibody drug conjugates (ADCs) are complex molecules which are often produced in dedicated facilities. At Bayer we have established a network of development and manufacturing facilities which allow us to develop and produce different classes of ADCs in an efficient and flexible way. The use of disposable systems and glove box technology enables us to perform clinical manufacturing of ADCs in multi-purpose facilities where antibodies as well as ADCs can be produced in the same cleanroom. Immunoconjugation is performed at 6 L – 100 L scale in a glove box to protect personnel and the working area from exposition to hazardous material. Cross-contamination is prevented by using dedicated equipment and single-use technologies in a closed system for conjugation and purification.

  • Ulrich Rümenapp - Head of Launch Preparation and Coordination , Bayer, Germany

09:50 10:30 (40 mins)

ADC - Chemistry, Production and Manufacturing

Developing an efficient, robust, and scalable conjugation process for bispecific ADC (BsADC)

The talk will broadly cover aspects related to

  • Development robust process for bispecific mAb conjugating to hydrophobic payload.
  • Controlling aggregation during bispecific conjugation and modelling intermediate process steps using design of experiments.
  • Removing process aggregates and unreacted payload using single step chromatography.
  • Sanjay Nilapwar - Purification Process Scientist, Medimmune, USA

10:30 11:00 (30 mins)

ADC - Chemistry, Production and Manufacturing

Morning Coffee and Networking

11:00 11:40 (40 mins)

ADC - Chemistry, Production and Manufacturing

Case Study: Use of disposable connectors in commercial ADC manufacturing

The presentation will cover a case study where disposable connector was used in a commercial ADC including selection of material, challenges encountered and sharing of best practices.

  • Albin Simoni - Senior Engineer Downstream Processing, Hoffmann-La Roche, Switzerland

11:40 12:20 (40 mins)

ADC - Chemistry, Production and Manufacturing

Case study from Piramal

  • Maria Kowal - Scientist within the Process Development Group, Piramal

12:20 13:20 (60 mins)

ADC - Chemistry, Production and Manufacturing

Lunch and Networking Time

13:20 14:30 (70 mins)

ADC - Chemistry, Production and Manufacturing

Interactive Discussion: ADC - Chemistry, Production and Manufacturing

This interactive discussion will focus on strategies for preparing and optimising processes, characterisation techniques and manufacturing facilities for ADC products.

Some of the topics to be discussed include:

  • Preparing processes and manufacturing ADC facilities for a growing market
  • Outsource production vs in house manufacturing?
  • With limited CMO capacity, how are companies preparing processes and manufacturing facilities for ADC production internally?
  • Unique production strategies facing the production and characterisation of ADCs
  • Technology investments and infrastructure when working with highly potent therapies
  • ADC production to deliver consistent, stable products
  • Optimising process development and scale up for ADCs
  • Heterogeneity assessment
  • Supply chain management for highly potent molecules
  • Filing a successful ADC CMC package: What questions are authorities coming back with?
  • Setting specifications for ADC products
  • Preparation for the increasingly potent, complex and non-native conjugated molecules emerging from R&D departments

14:30 14:35 (5 mins)

ADC - Chemistry, Production and Manufacturing

End of Post Conference Symposium

08:30 09:00 (30 mins)

Cell Therapy and Gene Therapy Bioprocessing Strategies

Registration

09:00 09:10 (10 mins)

Cell Therapy and Gene Therapy Bioprocessing Strategies

Chairperson's Opening Remarks

  • Dieter Hauwaerts - Vice President Operations , Celyad, Belgium

09:10 09:50 (40 mins)

Cell Therapy and Gene Therapy Bioprocessing Strategies

Cell and gene therapy manufacturing strategies

  • Julie Kerby - Head of Manufacturing Development, Cell Therapy Catapult, UK

09:50 10:30 (40 mins)

Cell Therapy and Gene Therapy Bioprocessing Strategies

Process development for MSC and T-cell based therapies

  • Dieter Hauwaerts - Vice President Operations , Celyad, Belgium

10:30 11:00 (30 mins)

Cell Therapy and Gene Therapy Bioprocessing Strategies

Morning Coffee and Networking

11:00 11:40 (40 mins)

Cell Therapy and Gene Therapy Bioprocessing Strategies

Impact of upscaling of manufacturing process on quality, safety and efficacy of cellular products: The journey for an off- the-shelf dendritic cell vaccine

The transition from a small scale process to a robust manufacturing process suitable for commercial demands in a cost effective manner, comes along with various challenges, as process changes may impact the quality, safety and efficacy of the product. During the presentation, aspects related to process development, optimisation in relation to product characterisation and clinical development will be addressed.

  • Sandra van Wetering - Chief Operations Officer , DCPrime, The Netherlands

11:40 12:20 (40 mins)

Cell Therapy and Gene Therapy Bioprocessing Strategies

Optimising a manufacturing platform for GMP production and purification of Retroviral and Lentiviral vectors

Molmed experience for the optimisation of a process for production and purification of GMP-grade Lentiviral and Retroviral vectors for gene therapy that responds to the needs of scalability for the application to both late stage clinical trials and commercial phase, while preserving consistent quality.

  • Luca Crippa - Downstream Specialist, Development Unit, MolMed S.p.A., Italy

12:20 13:20 (60 mins)

Cell Therapy and Gene Therapy Bioprocessing Strategies

Lunch and Networking Time

13:20 14:30 (70 mins)

Cell Therapy and Gene Therapy Bioprocessing Strategies

Interactive Discussion – Overcoming the challenges of cell and gene therapy production

This interactive discussion will focus on process development, optimisation and manufacturing strategies for cell therapy and gene therapy products.  Some of the following issues will be discussed:

  • Process development and optimisation for cell therapy and gene therapy products
  • Process changes: Methods, tactics and requirements for managing process change and demonstrating comparability
  • Applying bioprocessing technologies for large scale manufacturing
  • Strategies to overcome the unique manufacturing challenges of cell therapy and gene therapy products
  • Overcoming the challenges in USP and DSP
  • Purification strategies
  • Scalable platforms and Scale up strategies
  • Process automation
  • Raw material sourcing strategies and quality control: Control and risk assessment of raw materials – what systems do companies have to protect themselves?
  • Ensuring the long-term supply of raw materials
  • Global regulatory requirements and variations in cell therapy manufacturing: EU, US and Japan
  • Analytical and characterisation of products and processes
  • Cold chain and logistical supply

14:30 14:35 (5 mins)

Cell Therapy and Gene Therapy Bioprocessing Strategies

End of Post Conference Symposium

08:30 09:00 (30 mins)

Raw Materials - Variability, Sourcing and Supply Chain Management

Registration

09:00 09:10 (10 mins)

Raw Materials - Variability, Sourcing and Supply Chain Management

Chairperson's Opening Remarks

09:10 09:50 (40 mins)

Raw Materials - Variability, Sourcing and Supply Chain Management

Raw material variability and process performance

  • How do raw material attributes affect process performance?
  • Methods to monitor this
  • Raw material composition and variability is process performance
  • Raw material analytics, testing methods
  • Identifying CQA’s
  • Raw material sampling
  • Frances Sexton - Biotech Materials Management Tech Representative, Eli Lilly S.A.

09:50 10:30 (40 mins)

Raw Materials - Variability, Sourcing and Supply Chain Management

Viral Risk Evaluation of Raw Materials used in Biopharmaceutical Production

  • Classification of Raw Materials
  • Approach to Evaluation of Viral Risk
  • Assessment of Viral Risk Factors
  • Forward Plans
  • Robert Q. To - Manager of QC Virology and Cell Characteristics, Bayer HealthCare LLC, USA

10:30 11:00 (30 mins)

Raw Materials - Variability, Sourcing and Supply Chain Management

Morning Coffee Break

11:00 11:40 (40 mins)

Raw Materials - Variability, Sourcing and Supply Chain Management

Product Traceability – Determination of Authenticity, Origin and safe use of Foetal Bovine Serum

  • Jennifer Murray - Chairman, International Serum Industry Association, UK

11:40 12:20 (40 mins)

Raw Materials - Variability, Sourcing and Supply Chain Management

A presentation from Genzyme

  • Introduction Sanofi Genzyme
  • Supplier & material management proces
  • Challenges and how to address these Challenges
  • Case Studies
  • Summary and conclusions
  • Mark Huysmans - Material Agent Supply Chain, Genzyme, Belgium

12:20 13:20 (60 mins)

Raw Materials - Variability, Sourcing and Supply Chain Management

Lunch Break

13:20 14:30 (70 mins)

Raw Materials - Variability, Sourcing and Supply Chain Management

Discussion

Other points for discussion include:

  • Raw material risk mitigation and safety strategies
  • Risk assessment of raw materials
  • Specific raw material assessment: including disposables, tubes, bags, media, fittings etc.
  • Risk mitigation – elemental impurities and other raw material associated impurities
  • Regulatory perspectives
  • Specifications and regulations
  • Regulatory expectations
  • Standardisation – USP
  • Harmonisation globally
  • Pharmacopeia requirements and specifications
  • Vendor certification and sourcing
  • Supplier raw material testing
  • Vendor certification and verification
  • Improved qualification: quality documentation, raw materials for GMP
  • Single source suppliers
  • Evaluation as part of a wider product control strategy
  • Regulatory surveillance reports when sourcing information from vendors
  • Improved transparency
  • Change notification and audits
  • Frances Sexton - Biotech Materials Management Tech Representative, Eli Lilly S.A.
  • Robert Q. To - Manager of QC Virology and Cell Characteristics, Bayer HealthCare LLC, USA
  • Mark Huysmans - Material Agent Supply Chain, Genzyme, Belgium
  • Jennifer Murray - Chairman, International Serum Industry Association, UK

14:30 14:35 (5 mins)

Raw Materials - Variability, Sourcing and Supply Chain Management

End of Post Conference Symposium