Potency is an important critical quality attribute of any large molecule drug product and a precise and accurate assay is required for the release of drug product under Good Manufacturing Practice (GMP). Potency assays are technically difficult to develop and transfer but are also an essential part of the analytical strategy in any drug development pathway.
The potency assay is used to measure the ability of a drug to elicit a particular response at a certain dose in a relevant biological system and should ideally reflect the known mechanism of action of the drug and that it is related to the expected clinical response.
Developing a suitable potency assay is fraught with challenges and so a well thought-out plan and an understanding of what is important at each stage can help enormously.
In this webinar, the presenter will focus on the cell-based potency assay, the principles of which also apply to ligand-binding assays (ELISA).
Specifically, the webinar will cover:
- An introduction to relative potency assays including regulatory requirements, why a dose range is used and how to assess similarity to a reference standard.
- Specific considerations for development and optimisation of the assay for GMP environment. Including
- Choice of plate layout and cell culture format
- Optimising assay parameters such as incubation times, temperature and cell passage number
- Analysis of the data produced by your developed assay
- Differentiating and understanding the differences between system suitability criteria and sample criteria
- Strategies used to evaluate the performance of the potency assay prior to the validation phase including useful tips on monitoring the performance of the assay and what to track once the assay is developed
Emma Bowen, PhD, Senior Assay Development Scientist, Covance
Dr. Emma Bowen is an assay development scientist who, for five years at Covance, has experience with developing and optimising cell-based potency assays for a range of large molecules. From monoclonal antibodies, to hormones, to cell and gene therapy molecules, Dr. Bowen has developed and validated many assays into fully GMP-compliant QC methods. With a background in high-throughput assay optimisation from a PhD in RNAi screening at the University of Sheffield and experience of GMP study management, she has helped many clients take the steps required to have an informative potency method.Message Presenter
Who Should Attend?
Head, Director, CxO, Managing Director, Senior Director, VP, Consultant, Lead Scientist, Staff Scientist of:
- Quality Analytics/ Quality Control
- CMC Analytical
- Manufacturing Control
- Manufacturing Quality
- CMC Program Management
- CMC Leader
- CMC Regulatory Affairs
- CMC Consultant
- CMC Pharmaceutical Analysis
What You Will Learn
In this webinar, attendees will learn about:
- What a relative potency assay is and why it is important
- Factors to consider when developing and optimising a potency method
- What appropriate system and sample suitability criteria are and how to set them
- Tips for successfully transferring a potency method to a CRO
Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives.
Covance is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise. We generate more safety and efficacy data to support drug approvals than any other company, supporting our clients’ complete lifecycle management.
Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Visit us at www.covance.com.