Tracking Cells Podcast E4: Understanding Quality, GMP & Change Control in CGT

In Episode four of the Tracking Cells podcast, Helen Hopkins is joined by Edward Armstrong, Vice President of Quality for Mustang Bio, and Dr Matthew Lakelin Co-founder and Vice President of Scientific Affairs & Product Development at TrakCel. They discuss quality, GMP and change control in CGT including; strategies and technologies that can streamline the supply chain, reducing delays and ensuring treatments reach those in need by digitalizing the process. Listen below.

Edward Armstrong | Mustang Bio

Edward is recognized in the industry for knowledge and understanding of Quality / Regulatory trends and a pragmatic common-sense approach to quality and compliance. Edward is a proven resourceful, imaginative, and dynamic leader and team builder with 25 years of experience in Good Manufacturing Practice (GMP) for Pharmaceutical, Medical Device, Biotechnology, and Cell / Gene Therapy.

Dr Matthew Lakelin | TrakCel

Matthew holds a PhD in Pharmacology and has over 20 years’ experience working in the pharmaceutical and biotechnology industry. Matthew has led the deployment of TrakCel’s software to a wide range of advanced therapies (including CAR-T, TILs, personalised immunotherapies, neoantigen cancer vaccines) and in his role as VP Scientific Affairs is a key spokesperson and responsible for ensuring that TrakCel solutions continue to evolve to meet industry needs.

Episode 4: Understanding Quality, GMP & Change Control in CGT

In this insightful podcast, Edward and Matthew delve into the complex world of time-sensitive supply chains within the Cell and Gene Therapy (CGT) sector. They explore the intricacies of orchestrating these supply chains efficiently, highlighting key differences compared to the broader pharmaceutical industry and addressing the unique challenges faced.

A central theme throughout the episode is the importance of having a single source of truth through the supply chain and how an orchestration system facilitates this, it ensures accurate and up-to-date information is readily available to all stakeholders. They emphasize how a centralized platform fosters effective communication among different parties involved in the supply chain, from manufacturers to logistics providers and healthcare institutions. By reducing miscommunication and delays, a digital system ultimately saves precious time in delivering life-saving therapies to patients in need.

Listen below via Spotify, or search for 'Tracking Cells' on your favourite podcast platform.

Listen to our other Tracking Cells podcasts via our website, or find them on Spotify, Apple Podcasts, Amazon and other popular podcast platforms.