Validation of Complex Cell-Based Potency Methods


Determining the potency of a biologic may require multiple methods.  In addition, some methods may have complex responses that require critical fine-tuning to allow consistent collection of viable data. Complex methods can be validated and can provide consistent data if approached appropriately. Quality and laboratory professionals faced with validating a complex method for a novel product should attend this webinar to gain insights into navigating multifaceted methods.  In addition attendees will receive recommendations on addressing orthogonal methods that support the validation of the selected potency method. Included is a discussion of selection of the method and the cell line.  Also, correlating the method with the pharmaceutical activity of the product will be addressed.  Finally, the timeline for method validation will be discussed as well as implementation of the validation per the protocol.

Course Objective:

• Correlation of method with activity
• Understanding requirements for complex, multi-stage methods
• Setting appropriate timelines
• Verification of critical materials
• Process monitoring
• Assessment of orthogonal methods
• Validation parameters
• Validation protocol

Course Outline:

• Identification of pathways involved in activity
• Selection of potency-indicating method(s)
• Identifying the cell line
• Selecting the assay platform
• Method development
• Creation of MCB and WCB
• Consideration of orthogonal methods
• FDA/EMEA/USP Guidelines
• Selection and documentation of reference standard
• Timeline for method validation
• Annual updates

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Compliance Professionals
• Validation Scientists
• Quality Assurance
• Quality Control
• Regulatory Affairs
• Laboratory Managers
• Assay Development Specialists working in biopharmaceuticals, pharmaceuticals, natural products/botanicals

Gwendolyn Wise-Blackman,

Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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