An event that presents comparability strategies from leaders in the field for a range of therapeutic proteins with a strong emphasis on providing suitable data to the regulatory authorities to reduce difficulties and delays and to ensure safety and efficacy with every batch of drug. Industry case studies from various types of change implementation at different stages of development will be presented together with regulatory advice and plenty of opportunity for discussion.
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Tuesday, April 5
4:30 pm Registration for Part Two
5:00 – 6:00 Welcome Reception
Wednesday, April 6
8:00 am Registration and Morning Coffee
Pat Cash, Ph.D., Senior Director, Analytical Biochemistry, MedImmune, Inc.
8:25 Chairperson’s Opening Remarks
8:30 Assessing and Managing Drug Substance Manufacturing Changes in the Post Pivotal Arena
R. Graham McCartney, Ph.D., Technical Lead, Biotechnology, Eli Lilly
A robust comparability strategy is necessary to ensure that data from previous studies undertaken during drug development remain applicable as the programme moves forward to commercialization. The presentation will provide examples of tools used to assess the impact of Drug Substance manufacturing change and subsequent work establishing comparability in post pivotal scenarios. Careful consideration will be given to the evaluation of the risk associated with the change, with particular focus on the potential to impact CQAs.
9:00 Process Lifecycle Management: To Change or Not to Change?
Alain Bernard, Ph.D., Vice President, Pharmaceutical Process Sciences, UCB Group
This presentation addresses the basic question of whether process changes are absolutely necessary or not, and when a change is implemented, which strategies should be elaborated as early as possible in development to mitigate risk of changes later in the development or once on the market.
9:30 Analytical Lifecycle Management for Licensed / Legacy Products
John T. Stults, Ph.D., Director, Protein Analytical Chemistry-2, Genentech, Inc., a member of the Roche Group
In the years following the initial market approval for a product, the understanding of product quality attributes will evolve: improved analytical techniques and strategies are developed, a manufacturing history is generated, and new biological understanding may be discovered. This presentation discusses the analytical lifecycle management for licensed biologics, including evaluation and updates to molecule characterization, comparability plans, and control systems.
10:00 Sponsored Presentation (Opportunity Available)
10:20 Networking Coffee Break with Exhibit and Poster Viewing
11:00 Roller Bottles to Bioreactors: Comparability Testing Using Bioassays on a b/h PIV3/RSV F2 Candidate Vaccine
Alfred Pan, Ph.D., Associate Director, Analytical and Process Technologies, MedImmune, LLC
MEDI-534 (bovine /human parainfluenza type 3 / respiratory syncytial virus F2) (b/HPIV3/RSV F protein) is a live, attenuated intranasal vaccine, under development, for the prevention of lower respiratory tract disease caused by RSV or HPIV3 in young infants. This chimeric vaccine expresses the human PIV3 fusion protein and hemagglutinin-neuraminidase in a bovine PIV3 viral backbone. As part of process improvement and scale up, the original roller bottle process will be replaced with a bioreactor process. A case study will be presented using bioassays to compare the vaccine produced with the two processes.
11:30 Working with CMOs: Practical Experiences with Analytical Method Transfer
Stacey Traviglia, Ph.D., Senior Scientist, Analytical Technology, Biogen Idec, Inc.
When working with CMOs, planning, time and resource allocation are critical, and initial discussions on training and equipment requirements can save valuable time. Important features include: understanding the robustness of the methods and sources of variance; employing validation and assay control to set acceptance criteria and foresee potential failures, and selection of appropriate statistical analyses. These aspects will be discussed in conjunction with relevant case studies.
12:00 pm Limiting Risks Associated with the Presence of Protein Aggregates in Biologics
Ewa Marszal, Ph.D., Chemist, Laboratory of Plasma Derivatives, Division of Hematology, CBER, FDA
Protein aggregation potential is an inherent property of many protein products. Limited understanding of their interaction with our immune system usually precludes accurate predictions of their impact on drug safety and efficacy, which should be assessed on a case-to-case basis. Prerequisites increasing assurance of high product quality such as understanding molecular mechanisms of aggregation, understanding processes inducing aggregation, optimized formulation, and detailed characterization of the product, as well as evaluation and control of associated risks will be discussed.
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:55 Chairperson’s Opening Remarks
Nadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group, Inc.
FEATURED PRESENTATION
2:00 New Ways of Measuring Visible and Sub-Visible Particles
 Pat Cash, Ph.D., Senior Director, Analytical Biochemistry, MedImmune, Inc.
Particles are sometimes observed in protein solutions, particularly in high concentration formulations. Protein particles may vary greatly in visibility and size from invisible (sub-micron) to visible (millimeter). Biopharmaceutical companies are required to monitor and minimize the presence of visible and sub-visible particles in their products. A new, semi-quantitative method for assessing visible particles will be presented, along with new analytical techniques for sub-visible particle detection and characterization.
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2:30 Host Cell Protein Assays – Common Mistakes and Misconceptions
Nadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group, Inc.
With both commercial and custom-developed HCP assays, there are a few critical issues that can have major impact on the accuracy of results. Failure to recognize and resolve these issues can substantially impact project timelines and the ability to establish reliable HCP specifications. This presentation will provide an overview of HCP assays and discuss how to successfully address the major issues to avoid critical technical and regulatory mistakes.
3:00 Application of PAT and Near Infra-Red Technology for Process Characterization for the Production of Live-Attenuated Vaccines (LAIV)
Misa Sugui, Associate Scientist, Cell Culture & Process Development, MedImmune Vaccines
3:30 Networking Refreshment Break with Exhibit and Poster Viewing
4:00 Change Implementation: A Tiered Comparability Approach
Paul J. Gil, Ph.D., Deputy Director, Global Regulatory Affairs, Bayer HealthCare
Comparability strategies for licensed biologic product changes may extend beyond the analytical phase. When is the next step toward clinical studies necessary? What are the Regulatory Authority expectations? A recent case study will be analyzed - from strategy to outcome.
4:30 Regulatory Authority Feedback on Comparability Studies Performed in Relation to a Process Optimisation
Kirstin Bislev Hansen, M.SC., Senior Regulatory Project Manager, Regulatory Affairs, Marketed Products, Novo Nordisk A/S
This presentation will describe the response given by regulatory authorities for approval of a second-generation process of recombinant insulin utilising a new expression system. Additionally, the fermentation, recovery and purification process was changed and the site of manufacture.
5:00 – 6:00 Breakout Discussions
These are interactive moderated discussions on topics of interest in the field of comparability for change implementation and biosimilars
- Development and Manufacturing Strategy for Minimizing the Need for Comparability Studies
- Control and Measurement of Visible and Sub-Visible Particles
- Working with the Regulatory Authorities
- Requirements for Approval of a Biosimilar Product
- Managing Successful Technology Transfer
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6:00 End of Day
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