The demand for Advanced Therapy Medicinal Products (ATMPs) to treat diseases continues to grow, and, for many patients, ATMPs represent the last treatment option. As a result, it is crucial for manufacturers to produce and deliver these therapies in a timely manner while ensuring they meet all required safety and efficacy standards.

With the introduction of new manufacturing and testing methods, such as automation, decentralized models, and rapid testing; adopting a risk-based approach for testing and releasing ATMPs is no longer optional—it is essential.

This webinar will examine the potential risks involved in enabling just-in-time or real-time release of ATMPs. We will assess each stage of an example traditional autologous manufacturing process and identify potential risks and the factors that could allow for more efficient, timely release of these therapies.

While the webinar will focus on autologous manufacturing as an example, the insights shared can also be applied to other manufacturing methods.

The views and opinions expressed during the webinar are those of the presenter and do not reflect those of Adaptimmune or its affiliates.

Presented by Irving Ford, VP of Quality at Adaptimmune

Irving Ford is currently the VP of Quality at Adaptimmune. Irving is a proven executive leader with over 29 years of Quality experience in pharmaceutical/biotechnology and cell/gene therapy industries.

Irving has successfully contributed to the approval of four (4) commercial ATMP products to date.

Irving is an active member of PDA and the PDA ATMP Advisory Board.  Irving’s co-authored PDA’s ATMP Points to Consider document and the published White Paper – Risk Assessment Approach to Microbiological Controls of Cellular Therapies and has also contributed to numerous PDA Technical Reports.

Followed by Owen Griffin, Senior Director, Microbiology at Rapid Micro Biosystems

Owen has 15 years of experience working in and leading laboratories for contract research organizations (CRO), contract development and manufacturing organizations (CDMO), and drug product manufacturing companies. During his career he has worked in both sterile and non-sterile GMP facilities, leading teams that support API, excipient, and fill finish manufacturing activities. Over his career he has supported the design of manufacturing cleanrooms and processes, environmental monitoring programs, implemented contamination control strategies, designed microbial method validations, and led global initiatives as a Microbiology subject matter expert (SME).

Owen earned a B.S. in Microbiology and Laboratory Technology from Auburn University. He is currently the Sr. Director, Microbiology at Rapid Micro Biosystems. In this role his team is responsible for new product development activities and customer applications services.

Followed by a live Question and Answer Session

Sponsored by Rapid Micro Biosystems

Rapid Micro Biosystems^® (RMB) creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of cell and gene therapies, pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products. The company’s Growth Direct^® is the only fully automated, non-destructive growth-based system for multiple QC test applications: environmental monitoring, water, bioburden, and sterility testing. Automating rapid compendial QC micro testing ensures data integrity, compliance, and operational efficiencies. RMB is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes.