SMART CAMP Seminar Series: "Viral contamination in biologic manufacture and implications for emerging therapies" by Dr. John Duguid (Vericel Corporation)

Date:13^th July 2020

Time: 8.00pm (Singapore)

OnlineSeminar

Viralcontamination in biologic manufacture and implications for emerging therapies

Abstract:

Using rapid microbiological methods for product testing and release is critical for autologous cell therapy products with short shelf lives. Regulatory acceptance is achievable in such cases and becoming more straightforward as more companies implement these methods. It is preferable to do so during product development and licensure because changes to applications for marketed products often require extensive comparability packages. An official compendial method certainly would facilitate more widespread adoption of such modern microbiological detection techniques.

In1999, Vericel began work on rapid microbiological methods to ensure the safety of its cell therapy products (Epicel®skin grafts for severe burns, Carticel® first-generation cartilage repair, andMACI® third-generation cartilage repair), which have shelf lives as short as 24hours. Vericel received FDA approval to use BacT/ALERT testing for Carticel products in 2004, EMA approval for MACI products in 2013, and FDA approval for the latter in 2016. Here in this webinar, John Duguid, will take about Vericel’s experience with addressing the need for rapid sterility testing of cell therapy products and working with the FDA to establish a regulatory framework for its products.