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The third track of the Biotherapeutics Analytical Summit focuses on the practical application of analytical characterization for Comparability, Biosimilarity and Development purposes. It covers case studies with a variety of products and a range of analytical technologies. We have invited the FDA and regulatory experts to advise and to discuss regulatory challenges being experienced by the industry. This conference also covers the link between the process and analytical technologies for innovator products and for biosimilars.
Thursday, March 27
8:00 am Registration and Morning Coffee
8:30 Chairperson’s Opening Remarks
Jeffrey K. Glenn, Ph.D., Associate Director, Analytical Development, Janssen R&D
8:35 am The Commercial Product Lifecycle: Comparability Approaches and Control System Updates
John Stults, Ph.D., Director, Protein Analytical Chemistry, Genentech, Inc.
The product lifecycle of a biotherapeutic may span decades. During this period, a number of changes are expected which require comparability assessments, including process upgrades and manufacturing site transfers. Updates to the control system are also an important component of lifecycle management. Each of these exercises requires a well-defined strategy, and provides analytical challenges and opportunities. This presentation will describe approaches for the demonstration of comparability and for updating control systems, with case studies to highlight the analytical challenges and their solutions.
9:05 am Stage-Appropriate, Risk-Based Comparability for Drug Substance Manufacturing Process Changes
Kazumi Kobayashi, Ph.D., Director, Bioprocess Development, Biogen Idec, Inc.
9:35 am Comparability Case Study for a a Cell Line and Process Scale Change for a Monoclonal Antibody
Shanthini Jeyarajah, Ph.D., Associate Director, Biological Analytical Development, AVEO-Oncology
Changes to the manufacturing process including cell-line, process scale and site were made to increase the production of a monoclonal antibody during clinical development. A comprehensive comparability study consisting of analytical and non-clinical components has been performed to support the implementation of these changes. The analytical comparability study design, product attributes before and after process change and demonstration of comparability through release testing, extended structural and functional characterization and assessment of stability will be discussed in this presentation.
10:05 Characterization for Biosimilar Comparability Assessment
Fiona M. Greer, Ph.D., Global Director, Biopharma Services Development, SGS Life Sciences
Biosimilar development requires comprehensive physicochemical characterization side-by side with the originator to demonstrate “Biosimilarity”. This includes intensive characterization of multiple batches to determine variability of quality attributes. Strategies for primary and higher order structure comparability will be discussed particularly for antibodies where their size and complexity requires LC/MS/MS.
10:20 Coffee Break in the Exhibit Hall with Poster Viewing
11:00 am Comparability Assessment of Antibody Higher-Order Structure after Process Changes
Tom Lerch, Ph.D., Senior Scientist, Analytical Research & Development, Pfizer, Inc.
During the development of an antibody biotherapeutic, manufacturing process changes can affect protein structure, and consequently, drug function, efficacy and stability. As a result, comparability assessments are designed and implemented to evaluate product attributes before and after process changes. Established biophysical methods are lacking in quantitative evaluation of higher order structure (HOS) comparability. Strategies for evaluating HOS comparability in biotherapeutics and applying statistical analysis for biophysical comparability will be discussed.
11:30 am Antibody Characterization Using a Time-Resolved FRET FcRn Binding Assay
Jeffrey K. Glenn, Ph.D., Associate Director, Analytical Development, Johnson & Johnson
FcRn receptor binding provides an estimate of >in vivo half-life, a tool for evaluating structure-function relationships, and determining lot-to-lot comparability. Due to the low-affinity interaction between antibodies and the FcRn receptor, a robust, easy-to-use format has been difficult to achieve. This presentation will describe an FcRn binding assay using the time-resolved fluorescence resonance energy transfer (TR-FRET) format. Results from different antibodies, examples of interference, and data demonstrating the stability-indicating nature of this method will be provided along with comparison to other FcRn binding formats.
12:00 pm Comparability Excercises During Biosimilar Development
Andreas Wattenberg, Ph.D., COO, Protagen Protein Services Gmbh
Comparability studies during biosimilar development are a key driver of process development. Depending on the development stage, the settings and challenges of such comparability studies are very different. The layout of studies from early development to the registration phase and life-cycle management will be discussed and data from such studies presented.
12:30 pm Luncheon Presentation> (Opportunity available, please contact Jon Stroup, email@example.com) or Lunch on Your Own
1:30 pm Chairperson’s Opening Remarks
Kenneth R. Miller, Ph.D., Senior Scientist, Analytical Biotechnology, Regulatory Sciences & Strategy, MedImmune, Inc.
1:35 pm Compendial Tests and Quality Attributes for Biotherapeutics – Special Challenges for Glycosylated Molecules
Tina S. Morris, Ph.D., Vice President, Biologics & Biotechnology, USP
Glycosylation is a non-template driven, highly process dependent post-translational modification, and presents special challenges in the manufacturing, analytical development and quality control of biotherapeutics. In the context of comparability exercises, both within the space of a single manufacturer and in assessing product quality across manufacturers, defining performance criteria for appropriate analytical approaches as well as setting acceptance criteria are key decisions – how good is good enough? This presentation explores how compendial standards can serve as benchmarks for best analytical practices in general and specifically for key quality attributes of well-characterized biotherapeutics.
2:05 pm Acceptable Changes in Quality Attributes of Antibodies and Assimilated Biopharmaceuticals
Robert Mayer, Ph.D., Scientist, Analytical Characterization, Sandoz GmbH
Variation in quality attributes comprising identity, strength and purity that are acceptable in the product life cycle has been debated extensively. This talk presents a study focussing on variation in marketed biologics. By analyzing the quality profiles of Rituxan®/Mabthera® (rituximab) and Enbrel® (etanercept) sourced from the market between 2007 and 2010, this presentation provides examples of acceptable variations for products that have remained on the market with unchanged product labels.
2:35 Molecule Assessment: Averting Problems in Development
Amy Hilderbrand, Ph.D., Scientist, Protein Analytical Chemistry, Genentech, Inc.
To assess the manufacturability of biological molecules coming from late stage research, a cross-functional team was established to characterize and evaluate possible issues that would hinder the development of these molecules into drug products. The evaluation includes stability assessment of specific motifs within the molecule under stressed conditions. This talk will focus on the analytical techniques used for early molecular assessment.
3:05 pm Refreshment Break in the Exhibit Hall with Poster Viewing
3:30 pm Regulatory Perspectives on Characterization and Comparability
Lixin Xu, Ph.D., Monoclonal Antibodies, Biotechnology, FDA/CDER
In the lifecycle of a biotechnology product, manufacturing changes to the drug substance or to the drug product are unavoidable. It is the responsibility of the manufacturer to demonstrate sufficient and appropriate comparability between pre-change and post-change products. Regulatory considerations from product quality perspective for the comparability process (package), for demonstrating analytical comparability and for comparability across the product manufacturing lifecycle will be discussed.
4:00 – 5:00 pm Breakout Discussions
Table 1: Comparability Challenges for >Glycosylated Therapeutics
Moderator: Tina S. Morris, Ph.D., Vice President, Biologics & Biotechnology, United States Pharmacopeial Convention
Table 2: Critical Quality Attributes and Critical Process Parameters
Moderator: Kenneth R. Miller, Ph.D., Senior Scientist, Analytical Biotechnology - Sciences & Strategy, MedImmune, Inc.
Table 3: Analytical Studies Required to Support Process Change, such as Scale Up, Change of Manufacturing Site, Formulation Change etc.
Moderator: John Stults, Ph.D., Director, Protein Analytical Chemistry, Genentech, Inc.
Table 4: Putting Together a Clinical Comparability Protocol
Moderator: Kazumi Kobayashi, Ph.D., Director, Bioprocess Development, Biogen Idec, Inc.
5:00 pm End of Day One of Comparability & Developability
5:30 – 8:30 pm Dinner Short Course*
SC3: The Science and Regulation of Process Changes for Biologics
* Separate registration required, click here for details
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