Due to their origin in living systems, biologics are complex and inherently variable, posing unique challenges for characterization, consistency, safety and efficacy. Biologics assays are critical for assuring the identity, potency, purity and quality of biologics and ensuring both adequate control of manufacturing processes and stability of the products over time.
For the greatest efficiency, assay development should be choreographed in a phase-appropriate manner such that assays are fully validated using the final to-be-marketed product formulation in Phase III trials. Understanding the regulatory perspective on potency or biological activity is essential for ensuring that the assays developed provide the information needed to support submission and approval.
This webinar will explore the nuances of analytical testing and assay development for biologics and cover regulatory expectations for potency assays for these complex therapeutics.
Register for this webinar today to gain insights into the development stages for biologics assays, the analytical testing model for biologics and more.
Speakers
Chris Hendry, Vice President, Pharmaceutical Technology, Premier Consulting
Chris Hendry is a veteran in the development and manufacture of protein biologics with an emphasis on selection and oversight of drug substance and drug product contract manufacturing organizations, development of commercial manufacturing processes and quality risk management. He is also experienced in the transfer and validation of drug substance and drug product manufacturing processes; preparation of CMC sections of INDs, BLAs and CTDs; project management of cross-functional-development teams and GMP facility and equipment design, validation and development master planning. Mr. Hendry has a Bachelor’s degree in Biochemistry from the University of Maine.
Message Presenter
Olu Aloba, PhD, Vice President, CMC Services, Premier Consulting
Olu Aloba has more than 25 years of leadership experience in pharmaceutical research and development, pharmaceutical technology, and regulatory strategy. He is a subject matter expert in drug product development, with special expertise in the application of quality-by-design (QbD) to formulation and process development, analytical development, and development strategy. He is a registered pharmacist and holds a US Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society.
Olu joined Premier Consulting in 2014 and, in his current role, leads Premier Consulting’s Chemistry Manufacturing and Controls (CMC) service offerings focusing on pharmaceutical development strategizing, planning, execution, and documentation in support of drug development programs for Premier Consulting’s clients. He also serves as senior technical advisor on Premier Consulting’s drug, device, and biologics initiatives and is responsible for continuing development of the pharmaceutical quality expertise, knowledgebase, and policy at Premier Consulting.
Olu earned a Bachelor of Pharmacy degree from University of Benin, Nigeria, and MS and PhD degrees in Pharmaceutical Science from St. John’s University. Dr. Aloba is a co-inventor on several pharmaceutical patents and has authored scientific articles and presented his work at numerous conferences.
Message PresenterWho Should Attend?
This webinar will benefit Managers and above at biotech and specialty pharma companies with job functions including, but not limited, to:
- Chemistry, manufacturing and controls (CMC)
- Regulatory affairs
- Project management
- Preclinical development
What You Will Learn
Attendees will learn about:
- Stages of assay development
- Principles of phase-appropriate assay development
- The model of analytical testing for biologics products
- Regulatory requirements and strategies for successful regulatory agency interactions
Xtalks Partner
Premier Consulting
Premier Consulting is a strategic product development and global regulatory consulting company dedicated to helping biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments. Our end-to-end solutions in strategy, regulatory, nonclinical, CMC, quality, and commercial help sponsors build and execute development plans that meet regulatory requirements and deliver results for sponsors and the patients they serve.
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