Science & Standards Symposium—Biologics & Biotechnology: Advancing Quality Standards through Analytics and Assays

USP’s 2011 Science & Standards Symposium provided a unique, interactive forum for biologics and biotechnology (B&B) professionals, regulators, and researchers to engage in discussion with a panel of international experts. Topics were related to B&B analytics and assays, including the regulatory landscape and the role of USP standards.

Symposium included two tracks and presentations by featured speakers Steven Kozlowski, Ph.D., Director of the Office of Biotechnology Products, FDA, and Gillian R. Woolett, MA, DPhil, Chief Scientist at Engel & Novitt, LLP.

Track I ─ USP’s 4th Bioassay Workshop. Track I built on the past USP workshops and focused on the use of bioassay data sets and case studies to address compliance challenges as new USP Chapters move toward official status.

Track II ─ Quality and Regulatory Perspectives.Track II featured discussions on key issues related to quality by design and the determination of critical quality attributes for biologics (e.g., monoclonal antibodies and enzymes).

Topics:

  • Measurement of post-translational modifications, use in product/lot comparability
  • Critical quality attributes and compendial standards for monoclonal antibodies and enzymes
  • Role and importance of biological potency reference standards for Biologics
  • Modernizing enzyme standards by incorporating new analytical technology
  • Enforceable standards for ancillary and process materials
  • Use of case studies in analyzing bioassay data in product development
  • Regulatory expectations for potency assay transitions: animal to cell-based, cell-based to binding assays, and others

When: October 3–6, 2011

Where: Westin Seattle; Seattle, WA, U.S.

Agenda

Participants:

  • Biopharmaceutical/biotechnology industry professionals
  • Biopharmaceutical development scientists
  • Pharmaceutical industry professionals
  • Regulatory experts for biologics
  • Biosimilar manufacturers
  • Bioassay practitioners and software experts
  • Biostatisticians
  • Analytical development scientists
  • QA/QC specialists for biologics