Virtual Europe Discussion Group
The Virtual Europe Discussion Group provides opportunities for the broader community of industry, academic, and regulatory professionals to meet and share ideas and experiences. The group will discuss scientific challenges in the field of biopharmaceutical development and regulation with a focus on Europe.
The Virtual Europe Discussion Group goals include:
- Share learning across industry, academia, and health authorities across Europe, with a focus on speakers from across the region.
- Generate new scientific and technical insights and solutions for developing biopharmaceutical products in the future.
- Contribute to the expansion of CASSS’ mission, vision, influence, and community in Europe.
Click on the sections below for detailed information:
Platform Analytical Procedures | Virtual | 22 May 2025 15:00 CEST
The Virtual Europe Discussion Group provides opportunities for the broader community of industry, academic, and regulatory professionals to meet and share ideas and experiences. Join Featured Speakers Mark Eggink, Byondis, Mark Milford, Eli Lilly and Company, Karen Rule, Pfizer, Inc., and Featured Panelist R. M. "Martijn" van der Plas, Medicines Evaluation Board. Registration closed 21 May 2025.
Platform Analytical Procedures | Virtual | 22 May 2025 15:00 CEST
Join Featured Speakers Mark Eggink, Byondis, Mark Milford, Eli Lilly and Company, Karen Rule, Pfizer, Inc., and Featured Panelist R. M. "Martijn" van der Plas, Medicines Evaluation Board.
Platform Analytical Procedures
This program delves into the establishment and optimization of platform analytical procedures in the pharmaceutical industry, as enabled by ICH Q2(R2) and ICH Q14.
Here are the key takeaways from the program:
- Streamlined Early Phase Development: The application of ICH Q2 and Q14 guidelines can streamline the development of analytical procedures in early phases. Leveraging prior knowledge and conducting risk assessments makes the process more efficient while remaining data-driven. Flexibility in platform analytics is crucial to accommodate dynamic development environments.
- Retrospective establishment: Leveraging prior knowledge from multiple product-specific validation exercises can enable the establishment of robust platform analytical procedures. A potential approach will be illustrated using the example of protein content determination by UV spectrophotometry. Required data to extend the use of the platform analytical procedure to other products will be discussed.
- Commercial Readiness: Using historical data and prior knowledge can expedite method validation and achieve rapid commercial readiness. This approach can reduce redundant work and streamline the validation process for monoclonal antibodies and mAb-like therapeutics.
- Challenges and Strategies: The program will highlight successful approaches and ongoing challenges in implementing platform analytical procedures, providing practical examples and justifications needed for commercial submissions.
| 15:00 –15:15 CEST | Welcome and Introduction Christof Finkler, F. Hoffmann-La Roche Ltd. Jamie Moore, Gilead Sciences |
| 15:15 – 15:30 CEST | Streamlining Analytical Platform Procedures: Addressing Early Phase Development Challenges The recent updates and integration of ICH Q2 and Q14 present a significant opportunity to enhance platform analytical procedures. By leveraging prior knowledge and conducting risk assessments, this process can become more streamlined while remaining data-driven. Given the ongoing need to accelerate process development timelines and the limited number of R&D and GMP batches in early phase development, there is limited time and information available to develop robust analytical methods. This is where platform analytics can play a crucial role. With the updates to ICH Q2 and Q14, it is now possible to initiate a phase-appropriate approach right from the start. However, while an analytical platform procedure can be established, it may not always be effective in a highly dynamic company. Therefore, it is essential for the analytical platform procedure to be flexible to maximize its benefits. This presentation will focus on a strategy for utilizing an analytical platform approach during early phase development, with ICH Q14 serving as a guiding framework. |
| 15:30 – 15:45 CEST | Retrospective Establishment of Platform Analytical Procedures – Considerations for Protein Content Determination by UV Spectrophotometry When validating a platform analytical procedure in accordance with ICH Q2(R2) and ICH Q14, the validation approach adopted can be influenced by the maturity of the analytical procedure. In some cases, an analytical procedure which has already been utilized across an existing portfolio of products offers the opportunity to retrospectively assess the performance of the analytical procedure across multiple product-specific validation exercises. This provides a wealth of prior knowledge when considering a platform analytical procedure, can potentially enable a retrospective establishment of the platform analytical procedure. Protein content determination by UV spectrophotometry is a commonly utilized technique for monoclonal antibodies (mAbs) and mAb-like therapeutics and lends itself well to the establishment of a platform analytical procedure. In the context
of UV spectrophotometry, this presentation will consider the analytical procedure attributes and parameters constituting a platform analytical procedure, and the assessment of performance characteristics across multiple product-specific
validation exercises to demonstrate the multi-product performance of the analytical procedure. Once the validated platform analytical procedure has been successfully established, consideration will be given to the data required when
extending the validated platform analytical procedure to a new product or products. |
| 15:45 – 16:00 CEST | Commercial Submission Considerations for Platform Analytical Procedures The updates to ICH Q2 and Q14 define analytical platform procedure and offer the opportunity to conduct abbreviated method validation through use of enhanced development, establishment of an analytical platform and risk assessment. Industry
has extensive experience developing monoclonal antibodies (mAbs), including method development, validation, transfer, and implementation at commercial sites around the world for in-process, release, and stability testing. This prior
knowledge, experience and historical data can be used to expand the application of platform analytical procedures to mAbs and mAb-like therapeutics intended to reduce redundant work by adopting a streamline abbreviated validation approach
to enable rapid commercial readiness. This presentation will focus on providing examples of content and justifications needed in a commercial submission for a strategy establishing platform analytical procedures by leveraging prior
knowledge (retrospective). Successful approaches and continued challenges will be highlighted. |
| 16:00 – 16:05 CEST | Transition Break |
| 16:05 – 16:55 CEST | Panel Discussion |
| 16:55 – 17:00 CEST | Closing Remarks |
Featured Speakers
Mark Eggink
Byondis
Mark Eggink earned his PhD in analytical chemistry from Vrije Universiteit, Amsterdam, where he specialized in using multidimensional comprehensive chromatography and mass spectrometry to detect oxidative stress biomarkers. Since 2008, he has been working at Byondis (formerly Synthon Biopharmaceuticals). As a Principal Scientist, he leads a team dedicated to upstream and downstream process development support, method development, and quality control for innovative monoclonal antibodies and antibody-drug conjugates. His expertise spans chromatography, electrophoresis, and compendial testing, with a focus on critical quality attributes such as N-Glycans, aggregation, charge distribution, purity, fragmentation, and drug distribution. Additionally, he serves as an analytical project manager for various CMC projects and contributes to the analytical sections of regulatory documents.
Mark Milford
Eli Lilly and Company
Dr Mark Milford is an analytical scientist with over 25 years of industrial experience in the protein analytical field. Earning his PhD from the University of Southampton (UK), Mark’s industrial experience has spanned analytical roles in development, commercialization, and routine manufacture of biopharmaceuticals, most recently in the analytical testing of monoclonal antibody products. Currently holding a position of Director - Analytical with Eli Lilly, based at the Kinsale manufacturing facility, Milford has technical oversight of analytical aspects of new product introduction and commercialization for biopharmaceutical drug substances, both at the Kinsale manufacturing facility and across the Lilly analytical network, overseeing the analytical method lifecycle and driving analytical control strategy.
Milford has a particular interest in analytical procedure development, validation, and post-approval lifecycle from a large molecule perspective. As such, Milford holds the position of Industry Expert on the ICH Implementation Working Group for ICHQ2(R2) / ICHQ14, as well as Deputy Topic Lead for the EFPIA ICHQ2(R2) / ICHQ14 Support Group.
Karen Rule
Pfizer, Inc.
Karen Rule is a director in analytical R&D (Biotherapeutics Pharmaceutical Sciences) at Pfizer, based in Massachusetts, USA. She has been with Pfizer for 24 years working in multidisciplinary areas including bioassay/potency development, analytical project lead, and currently leads a group that is responsible for analytical regulatory strategy and authoring of analytical sections for the submissions across vaccines, mAbs, gene therapies, ADC, and other mAb-like products. Her experience has covered method development, characterization, comparability, control strategy, method validation/transfer, and health authority interactions. Over the past few years, Rule has been working with a team at Pfizer to help define the expectations and implement platform analytical procedures for late-stage products.
Featured Panelist
R. M. "Martijn" van der Plas
Medicines Evaluation Board
Dr R. M. (“Martijn’) van der Plas is a senior assessor for biological products at the Medicines Evaluation Board, and previously RIVM where he started working as assessor in 2000. His fields of attention include biosimilars, monoclonal antibodies, and recombinant proteins and plasma-derived products in general.
van der Plas obtained a PhD degree in 1999, with the thesis ‘Structure and Function of Human von Willebrand Factor’. He obtained a ‘doctorandus’ (M.Sc) degree in 1994 with a major in molecular pharmacology. van der Plas is a member of the Biologics Working Party (EMA/CHMP, Amsterdam) and an expert of the European Pharmacopoeia (Group 6B plasma products; MAB Working Party, EDQM, Strasbourg).
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