Cell therapy is a transformative cancer treatment that utilizes genetically modified cells from a healthy donor or patient's own immune system to attack cancer cells, but manufacturing these cells represents a major challenge for the industry. Although every therapy and process are different, there are a few key decisions that are critical to the success of any advanced therapy medicinal product (ATMP) and for the success of the company that plans to bring them to the clinic.

In this webinar, we will discuss three key areas to consider when you’re preparing to commercialize a cell therapy:

• Starting/raw material – the components you choose at discovery can ultimately define the success of your development and GMP manufacturing process. We’ll highlight some key watch outs and what to ensure is being provided by your suppliers.

• Controlled manufacturing process – the less human intervention needed, the better. We’ll talk about revolutionary closed-system technologies that offer exceptional flexibility, reduce hands-on time and more importantly, minimize the chances of contamination while delivering a consistent, reproduceable CAR-T therapy.

• Testing safety & quality – ATMPs have clear quality control tests that must be performed throughout the manufacturing process and product release, we’ll review essential tests that are required for lot release and regulatory filing and present solutions that save time and are accepted by regulators for lot release testing.

What you'll learn:

• Regulatory requirements for GMP ancillary materials for cell and gene therapy

• Closed-system manufacturing and how it can improve overall productivity and product safety

• Characterization and lot release testing, proper validation for regulatory CMC filing

Who should attend:

• Process development scientists

• Analytical development scientists

• QC specialists

• R&D/Preclinical researchers

• CMO/CDMO