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.
Learning 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
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.
Topics
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
Instructor
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.