Cell-Based Assays in a GMP Environment: Approaches for Clinical and Commercial Stability Studies

Biosimilars, Drug Discovery and Development, Life Sciences, Pharmaceutical,
  • April 17, 2018

Potency of biotherapeutics, often determined by cell-based assays, is one of the most important critical quality attributes. Potency must be monitored throughout the entire drug development cycle as it measures drug activity and provides a direct link to clinical efficacy. An ideal potency assay should represent a drug’s mechanism of action (MOA), as well as be specific and sensitive enough to detect changes and degradations of the product. Cell-based potency assays are intrinsically complex and may present challenges during development, validation, transfer and implementation.

This presentation will highlight the approaches used in developing consistent cell-based potency assays meeting regulatory expectations (USP <1032> and <1033>) and are suitable for cGMP stability testing. In addition, a phase appropriate potency method development and qualification/validation strategy will be discussed. Practices in support of successful cell-based assay transfer and long-term maintenance of the assay in the QC laboratory will be presented.

The discussion will include:

  • Challenges in establishing a robust cell-based potency assay
  • Routine assay performance monitoring
  • Analyst training and qualification requirements
  • Analytical working cell bank generation and characterization
  • Cell maintenance and growth tracking
  • Bridging studies for critical reagents

Speakers

Aryo Nikopour, Senior Vice President, Scientific and Technical Services, Nitto Avecia Pharma Services

Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services, has been with Nitto Avecia Pharma Services (formerly known as Irvine Pharmaceutical Services) since early 2004. Mr. Nikopour has nearly 30 years of experience in the pharmaceutical industry with expertise in the areas of chromatographic method development and validation, quality control, stability testing and associated cGMP regulatory requirements. Aryo brings significant pharmaceutical industry experience in product development of small and large molecules, including proteins, peptides and drug delivery platforms.

Prior to joining Avecia Pharma, Aryo served as the Director of Research and Development, at Pharmaceutical Product Development, LLC (PPD) where he was responsible for pharmaceutical development and stability programs that involved multiple development and manufacturing sites. Prior to PPD, Aryo worked at Solvay Pharmaceuticals and AlPharma Inc. Mr. Nikopour holds a Bachelor of Science degree in Chemistry from the University of Southern Minnesota.

Ming Li, Ph.D., Principal Scientist/Team Lead, Biopharmaceutical Development, Nitto Avecia Pharma Services

Dr. Ming Li, Principal Scientist and Team Lead in the Biopharmaceutical Development department at Nitto Avecia Pharma Services, has over 22 years of experience in the academic research and pharmaceutical drug discovery industries, including over 15 years’ focus on cell-based assay development. During this time, Dr. Li authored more than 21 publications in scientific peer–reviewed journals. Dr. Li oversees the bioassay group in support of method development, validation, and transfer of binding and cell-based potency assays as well as impurity assays for process development, product release and stability testing. Dr. Li received her Ph.D. from the Department of Molecular Biology and Biochemistry at the University of California, Irvine and received her Bachelor of Science Degree from Beijing Medical University, China.

Who Should Attend?

Senior biopharmaceutical/biotechnology industry professionals, including:

  • QA/QC Specialists for biologics
  • Validation Specialists
  • Regulatory Affairs staff for biologics
  • Outsourcing Professionals

Xtalks Partners

Nitto Avecia Pharma Services

Nitto Avecia Pharma Services is your single solution for premier contract development and manufacturing services. Nitto Avecia Pharma Services supports the pharmaceutical, biopharmaceutical, and medical device industries with a complete package of CGMP services (small to large molecules) including:

  • Formulation/process development
  • Parenteral manufacturing (liquid/lyo)
  • Analytical development
  • Analytical chemistry
  • Stability
  • Structural chemistry
  • Microbiology
  • drug delivery device testing

With three state-of-the-art facilities located on one campus in Irvine, California, Nitto Avecia Pharma Services’ experienced staff and robust quality infrastructure delivers client-centric solutions for early phase through post-market life cycle management. We invite you to visit us, audit our facilities, discover our insight, and learn more about our commitment to excellence. Learn more at www.aveciapharma.com or call (949) 951-4425.

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