Bioassay Development and Method Validation

Duration: 90 Minutes
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.
Bioassay Validation
Product ID: 504583
Objectives of the Presentation
  • 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
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.

Areas Covered
  • 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
Who will Benefit
  • Validation Scientists
  • QA
  • QC
  • Regulatory Affairs
  • Laboratory Managers
  • Assay Development Scientists
  • Manufacturing Professionals
Topic Background
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.
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  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Gwendolyn Wise-Blackman is a successful scientist/manager with increasing accountability for scientific expertise and budget in the pharmaceutical industry, including managing multiple projects. She has working knowledge of FDA/ICH GLP and GMP guidelines and has proven experience with cell-based potency assays, Cell-based neutralization assays, PK and immunogenicity ELISA used to support bioprocess techniques for large molecule therapeutics. Ms. Wise-Blackman also holds Research & Development expertise in High Throughput Screening, 7-transmembrane receptor binding assays, cell-based assays, cell culture, and ELISA. Ms. Wise-Blackman is gifted with excellent presentation skills as evidenced by numerous scientific speaking engagements and working knowledge of PMP principles. She was an invited lecturer for IBC and IVT conferences, 1999-2008.
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