Bioassays are a critical component of biologics drug discovery and development. However, ever-changing technology, approaches, and regulatory requirements make it difficult to keep projects on track and on budget. Cambridge Healthtech Institute’s Inaugural Optimizing Bioassays for Biologics will bring together key individuals from bioanalytical R&D, cell and antibody engineering, immunology, pharmacology, and preclinical and clinical development. Special focus will be given to the development and validation of potency assays, developing bioassays for multi-domain proteins, and establishing a standard for using cell-based vs. non-cell-based assays. Regulatory updates, expectations for novel constructs, and reference standards
will also be shared.
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2:00 pm Chairperson’s Opening Remarks
Janet L. Lathey, Ph.D., Director, Immunology and Assay Development, BioDefense Division, Emergent BioSolutions
2:05 New Technologies and Approaches to Bioassays
Max L. Tejada, Ph.D., Senior Scientist, Biological Technologies, Genentech, Inc.
Cell-based potency assays can be the most challenging of analytical assays to develop. They are expected to reflect the mechanism of action (MOA) of the therapeutic but must also be suitable for use in a QC environment. Different antibody formats, an increasing diversity of clinical indications with complex MOAs, and reduced timelines due to increased competition, make assay development more challenging. Various approaches and strategies will be presented to address some of these challenges, including the incorporation of new technologies and formats, as well as the use of surrogate measures of bioactivity.
2:35 Optimization of Ligand Binding Assay by Design of Experiment
Surendran Rajendran, Ph.D., Senior Research Investigator, BAS - Biologics, Bristol-Myers Squibb
Biotherapeutics research uses predominantly Ligand Binding Assay to quantitate biomarker, biologic drug and its immunogenicity at preclinical and clinical stages to establish the PK/PD relationship and thus to accelerate drug development. Making ligand binding assay by Design of Experiment (DoE) methodology has many advantages over traditional one factor at a time method. An easy to do DoE protocol for ligand binding assay is described that optimizes the three main assay performance parameters sensitivity, dynamic range and the background simultaneously.
3:05 Development and Optimization of a Potency Assay for a 7 Component Peptide Drug
Barbara Hebeis, Ph.D., Principal Scientist, CMC Bioassay and Genomics, NDA Analytics
For drugs consisting of multiple active components, potency has to be demonstrated for all components individually.This talk focuses on the development of a bioassay for a multi peptide drug. The format selected for this example, based on the drug’s mode of action, was the enumeration of drug activated T cells from primary murine splenocyte cultures isolated from animalsimmunised with individualpeptide components of the drug. Based on results demonstrating a moderate T cell response of ex vivo cultured and periodically re-stimulated rodent splenocytes we have developed a method suitable for routine, cGMP compliant potency testing using ELISpot for the detection of IL-2 released from activated T cells.
3:35 Reference Standards for Potency Assays – Future Directions
Jane Robinson, Ph.D., Principal Scientist, Biotherapeutics, National Institute for Biological Standards and Control, UK
With increasing numbers of biopharmaceuticals in development, including next-generation (modified or artificial) molecules and biosimilars, meeting future requirements for publicly available reference standards for potency assays will be challenging. Parent molecules and innovator products may prove unsuitable as standards for corresponding next generation or biosimilar products, with relative potency determination proving either impossible or method-specific and resulting in a requirement for product-specific standards.
3:50 Refreshment Break in the Exhibit Hall with Poster Viewing
4:30 A Regulatory Perspective on Bioassays for Evaluation of the Quality of Protein Drug Products
Baolin Zhang, Ph.D., Senior Investigator, Division of Therapeutic Proteins, Office of Biotechnology Products, Food and Drug Administration
For all protein products, drug-specific potency assays are required to assess product quality because the complex protein structures cannot be inferred from physical-chemical characterizations alone. A suitable measure of potency is essential to assure the consistency of the product dose, the consistency of the manufacturing process, and the comparability of product lots. This talk presents the principles in the design of bioassays, regulatory perspectives, and case studies for bioassays used in the evaluation of protein products.
5:00 Compendial Potency Assays and Associated Biological Reference Materials – Challenges in Assay Transition and Unit Maintenance
Tina S. Morris, Ph.D., Vice President, Biologics & Biotechnology, United States Pharmacopeial Convention, Global Science & Standards Division
With increasing frequency, especially for legacy biologics, animal assays are being replaced by in vitro assays of different formats. This transition is not always straightforward, as analysts may struggle to establish equivalence between assays that measure different attributes or sets of attributes. This presentation will focus on USP’s current efforts to include modern in vitro assays in the USP-NF to replace animal-based tests for well-characterized biologics.
5:30 A Statistical Approach to Bioassay Bridging and Transfer
Xianzhi Zhou, Ph.D., Senior Scientist, MedImmune
How does one bridge between bioassays? Assays frequently need to be replaced, whether it be a result of unsupported instrumentation or improved methodology. This talk will present a case study demonstrating how MedImmune approaches bioassay bridging and transfer using statistical guidance.
6:00 End of Day One of Optimizing Bioassays for Biologics
6:00 Registration for SC5
6:30 – 9:00 Dinner SC5: Developing Potency Assays to Ensure Successful Biologics *
Instructor: Timothy Schofield, Senior Fellow, MedImmune
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*Separate Registration Required
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