Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing.
This 2-day virtual seminar is designed to offer a broad overview of developing and validating a range of assay methodologies for biologics with specific key analysis of cell culture, assay variability, and DOE. Specifically, this seminar covers essential concepts related to cell-based potency methods, ELISA, and other methods supporting biologics. In addition to potency methods this seminar addresses immunogenicity methods for preclinical and clinical studies. The format of the seminar offers an examination of current best practices as well as time to dissect examples of documentation with emphasis on beneficial systems to consider. Scientists who attend this 2-day virtual seminar will gain knowledge that will be beneficial in helping to achieve well-controlled validated methods.
Learning Objectives:
- Understanding the different requirements for small versus large molecules
- Mapping appropriate timelines with decision points
- Designing, developing, optimizing, and validating key methods
- Potency methods, other release and stability methods
- Preclinical and clinical methods
- Use of DOE and statistical analysis
- Handling of critical materials
- Process monitoring concepts
- Assessment of orthogonal methods
- Assessing readiness for validation
- Defining the validation protocol with real-time capture of data analysis
- Maintaining quality through documentation
Who will Benefit:
Below titles working in biopharmaceuticals, pharmaceuticals, natural products/botanicals will be benefited by attending this seminar:
- Validation Scientists
- QA/QC
- Regulatory Affairs
- Laboratory Managers
- Assay Development Specialists
- Statistician
- CMC Titles
- Bio Assay
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
- Session Start Time: 08:00 AM
- Overview of Biologics and Biotechnology
- Differences between small molecule and large molecule therapeutics
- Assays required for biologics
- Timelines
- Regulatory guidances
- GxP in biologics
- Analytical CMC methods and bioassays
- Assays supporting product development, release, and stability
- Portfolio of required assays
- Mechanism of action and potency methods
- Selection of potency-indicating method(s)
- Assay formats/platforms
- Consideration of reagents, endpoints, signal to background
- Standardizing cell culture procedures
- Understanding and managing assay variability
- Overview of feasibility to validation
- Early development – feasibility
- Use of DOE
- Involvement of statisticians
- Development and final development
- Optimizing the assays
- Validation of cell-based methods
- Assays supporting preclinical and clinical studies
- Regulatory guidances
- Assay platforms
- Reagents, endpoints, signal to background
- Method development
- Assessing matrix effects
- Method optimization
- Validation parameters
- Incurred sample reanalysis
- Immunogenicity methods
- Screening methods
- Confirmatory methods
- Neutralizing antibody methods
- Biomarker validation
- Written procedures (methods, protocols, SOPs)
- Analyst training
- Maintaining quality in-house and in outsourcing
Gwen Wise-Blackman
Principal Consultant, Gwen Wise-Blackman Consulting, LLC
Gwen Wise-Blackman, Ph.D., 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), and Salix Pharmaceuticals. She is currently Principal Consultant at Gwen Wise-Blackman Consulting. Her career 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.
