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Bioassay Development and Method Validation

Duration : 90 Minutes

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 De Read more

The pharmaceutical industry has seen an increase in the number of biologics released to fight human disease. Large molecule therapeutics requires additional consideration when developing and validating supporting methods. This webinar will address steps to consider when developing bioassays with the expectation of successful completion of validation. Specifically, this webinar covers essential concepts related to cell-based potency methods, ELISA, and other methods supporting biologics. Specific topics covered in the webinar will include cell culture, multitrack development strategies, DOE, assay variability, and the validation protocol. Attendees will receive information that should be beneficial in helping to achieve well-controlled validated bioassay methods.

Course Objectives:

• Timelines and decision points
• The importance of early planning
• Following data-driven processes
• Designing methods with validation in mind
• Use of DOE and statistical analysis
• Handling of critical materials
Creating / characterizing / handling the cell line
• Process monitoring concepts
• Assessing readiness for validation
• Defining the validation protocol
• Data capture and analysis during validation
• Maintaining quality through documentation


Developing and validating bioassays is a critical necessity for scientists supporting biologic development and manufacturing. Development and validation of bioassays is often time consuming. The potential for higher variability than that found with analytical methods may lead to a requirement for extending the timelines to gather the data required to support moving from development to validation. Developing methods that move through validation is a requirement for release and stability testing of biologics. This webinar addresses several issues that can lead to failure while also offering information on how to plan for and to overcome those challenges.

Why Should You Attend:

Scientists, quality assurance / quality control professionals, and other professionals working with biologics will gain insight and tools allowing for greater success when developing and validating bioassays. Discussion of topics to consider during early planning stages may lead to increased awareness of issues that can arise with methods for biologics. An increased awareness of possible problems can lead to a better strategy for development and validation and overall performance of bioassays in active production environments.

Course Outline:

• Assays required for biologics
• Timelines
• Regulatory guidance's
• Assay formats/platforms
• Standardizing cell culture procedures
• Early development - feasibility
• Use of DOE
• Involvement of statisticians
• Optimizing the assays during development
• Understanding and managing assay variability
• Validation requirements
• Written procedures (methods, protocols, SOPs)
• Analyst training
• Maintaining quality in-house and in outsourcing

What You Get:

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

Who Will Benefit:

• Validation Scientists
• QA
• QC
• Regulatory Affairs
• Laboratory Managers
• Assay Development Scientists
• Manufacturing Professionals

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

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