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WEDNESDAY, April 14
1:00 Registration & Coffee
2:00 Chairperson’s Remarks
Alain Bernard, Ph.D., Vice President, Global Process Development and Industrialisation, UCB Group
Featured Presentation
2:05 How Major Process Changes Can be Implemented to Improve Product Quality
Alain Bernard, Ph.D., Vice-President, Global Process Development and Industrialisation, UCB-Group
Using a couple of examples of recombinant therapeutic proteins, we describe strategies that enabled us to implement major process changes either during clinical development phases or after initial launch on the market with the key objective of product quality improvement. We will illustrate how, in most cases, major changes can be appropriately and safely implemented and achieve the expected deliverable of an improved quality, and how this significantly contributes to process and product understanding with positive impacts for the patients. We will exemplify how an extensive array of analytical tools, including some low-throughput but highly indicative quality tests can be used to support a demonstration of clinical comparability when it is necessary.
2:35 Fc Functionality Assessment in Support of Comparability Studies during Process Development
Yucai Peng, Ph.D., Scientist II, Analytical Development, Biogen Idec, Inc.
Fc functionality represents a significant part of quality attributes of antibody drugs. We have developed several bioassays for assessment of Fc functionalities in support of process development or comparability studies. Among the assays developed, an FcγRIIIa binding assay based on Alpha technology was used widely for analysis of post-translational modification, drug substance stability, and mechanism of action. Applications of the FcγRIIIa binding assay as well as other bioassays in characterization of Fc functionality will be discussed.
Featured Presentation
3:05 Comparability of an Antibody during Late-Phase Clinical Development with Multiple Changes
Margit Jeschke, Ph.D., Head, Analytical Research & Development, Novartis Biologics / Process Sciences & Production, Novartis Pharma AG
Several changes were introduced in the manufacturing process of an mAb1 after Phase I: the Sp2/0 based expression system was replaced by a CHO cell line and the production site and scale were changed. Additional process changes were implemented with the transfer to the commercial production site associated with a further scale-up. The comparability studies associated with these changes required extensive biochemical and physicochemical characterization and stability studies, and also biological characterization and pre-clinical and comparative pharmacokinetics studies. The results of the in-depth analytical characterization are presented and implications and conclusions of the comparability exercises will be discussed.
3:35 Networking Refreshment Break, Poster and Exhibit Viewing
4:10 Development of Reliable and Robust Transferable Analytical Methods
Marco Riedel, Ph.D., Director, Quality Assurance, ProBioGen AG
Method transfer is a proof of quality and one of the biggest challenges for demonstrating reliability and feasibility. It should be considered early in method development. The human factor plays an important role. A clear definition of responsibility and reasonable timelines enable efficient method transfer. As soon as possible those involved should discuss problems in reproducibility and other validation parameters. This discussion will become the basis for relevant training and for the definition of acceptance criteria for the transfer. Method transfer is not a product: it is a process and needs a service oriented understanding of all parties.
4:40 Critical Biophysical Characterization for Establishing the Comparability of Biotherapeutic Compounds: a Comparative Study
Qin (Chin) Zou, Ph.D., Senior Principal Scientist, Bioprocess Analytic Department, Pfizer, Inc.
Drug manufacturers must demonstrate comparability of their products after process and formulation changes in order to ensure a product of similar quality, safety and efficacy. A critical quality test is biophysical analysis, where a variety of tools such as circular dichroism (CD) and fluorescence spectroscopy may be applied to monitor higher order structures that could potentially affect the drug potency. Distribution of size can also be evaluated by methods such as analytical ultracentrifugation (AUC) and dynamic light scattering (DLS). These are shown to complement traditional size exclusion chromatography (SEC) methods. Case studies on comparability using these techniques for different types of biologics are provided.
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5:10 Scale Down Analytics for Early Stage Screening and Design Space Determination – “Manufacturability by Design”
James Wilson, Ph.D.,Director Sales and Marketing, Avacta
Scale down analytical techniques open up the possibility to thoroughly characterise candidate molecules at an early stage. The information gained can be used to help select candidates which are compatible with a wide range process conditions, help in rational design of optimised processes and help understand the potential effects of process changes before they are made.
5:30 Break Out Sessions
Break out sessions are interactive moderated discussions on topics of interest to investigators in the field of Comparability. Problems are discussed and solutions are shared.
Table 1: Development and Manufacturing Strategy for Minimizing the Need for Comparability Studies
Moderator: Alain Bernard, Ph.D., Vice-President, Global Process Development and Industrialisation, UCB-Group
- How to develop a product to ensure future process lifecycle evolution
- Extent of product/process understanding necessary/sufficient
- Manufacturing strategies
Table 2: Requirements for Approval of a Biosimilar Product
Tony Weighous, MBA, Director, Solvias Inc
How similar is similar? Sharing of difficulties experienced by applicants What are the pitfalls of which the industry need be aware? Ways the regulators and industry work can together to encourage licensing of biosimilars What the industry want to communicate to the regulatory authorities regarding biosimilars
Table 3: Analytical Release Methods and Specifications
Moderator: Andy Hooker, Ph.D., Senior Director, Analytical R&D, Pharmaceutical Sciences, UCB-Celltech
- Analytical method development
- Control of product & process impurities
- Host Cell Protein assays
- Role of bioassays
- Quality attributes & specifications
Table 4: Development of Non-clinical Studies to get through Early Stage Development Quickly
Moderator: Susan Hurst, Ph.D., Associate Research Fellow, Pharmacokinetics, Dynamics, and Metabolism, Pfizer Global Research and Development
Table 5: Incorporation of Bioassays, Potency Assays and Binding Assays into a Comparability Program
Moderator: Xu-Rong Jiang, Ph.D., Associate Director, Analytical Biochemistry, MedImmune LLC.
- When to introduce functional assays and factors affecting choice of methods applied
- Advances and new developments in functional assays
- Coping with the variation – how many assays are required and can this be made easier?
Table 6: Working with the Regulatory Authorities
Moderator: Marjorie A. Shapiro, Ph.D., Chief, Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies, CDER/FDA
- Types of change that require comparability studies
- When are non-clinical and clinical studies required?
- What sort of bridging studies might be needed if more clinical data is required?
- How much validation is necessary and how much is too much?
- How much documentation is necessary and how much is too much?
- Post-marketing commitments organisations are expected to make
- Examples of how various cases have been dealt with – what has gone right and what has gone wrong
- Sharing of industry experiences – are the regulatory authorities raising the bar?
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6:30 Networking Reception in the Exhibit Hall
7:30 End of Day One