Building Analytical Strategies for Scalable Antibody Development
Early analytical choices in monoclonal antibody development can influence how programs progress through validation, technology transfer, and later-stage scale up and development.
This webinar explores how decisions made during the investigational new drug (IND) stage can impact validation readiness, technology transfer, and regulatory success. Focusing on molecular characterization, residual DNA control, and microbial contamination risk, it highlights common gaps that can emerge as programs advance.
Attendees will learn practical approaches on designing analytical strategies that are robust, adaptable, and fit for purpose across the different stages of development, helping reduce rework and support long term development success.
Attend this webinar to:
- Analyze common lifecycle vulnerabilities in IND-stage analytical strategies
- Evaluate whether early titer methodologies are structured for validation and technology transfer
- Assess residual DNA testing approaches for regulatory defensibility and scalability
- Determine how microbial control and identification frameworks should adapt as programs advance
Speaker: Sandi True, PhD (Staff Scientist, Field Applications, Thermo Fisher Scientific)
Sandi completed her PhD at the University of Nebraska Medical Center and Eppley Institute for Cancer Research focusing on RNA viruses. She has made a career in field applications after completing postgraduate training in laboratories with the Environmental Protection Agency and the FBI.
