Gene therapy is having a monumental year: how can the industry keep up with supply? Artwork

The BioInsights Podcast

The BioInsights Podcast: discussing the challenges of translating novel biologics from bench to clinic to market.

The BioInsights Podcast

Gene therapy is having a monumental year: how can the industry keep up with supply?

April 04, 2024 • BioInsights • Season 3 • Episode 6

0:00 | 23:36

Lauren Coyle, Commissioning Editor, Cell & Gene Therapy Insights, talks with Suman Subramanian, Head of Commercial Operations, Catalent Cell and Gene Therapy, to discuss the major achievements in the gene therapy market in 2023, with a focus on reliable manufacturing processes and strategies to enhance predictability while reducing waste in gene therapy manufacturing.

Lets start with the key milestones achieved in the gene therapy market in 2023 and how these advancements have impacted the therapeutic landscape.

What supply chain strategies have proven effective in addressing accelerated timelines associated with gene therapy development?

Focusing on the challenges in developing reliable and scalable manufacturing process for gene therapies, what strategies or innovation can be implemented to overcome these to ensure a robust manufacturing pipeline?

Can you elaborate on the specific challenges in AAV development and manufacturing and how the industry is working to overcome them?

How can companies effectively plan early for a commercial-ready process, and what role does collaboration with experienced partners play in achieving this goal?

How can a partner with late-phase and commercial manufacturing experience contribute to the success of gene therapy development, both in terms of solidifying processes and navigating the regulatory pathway?

Given the importance of supply chain management in delivering gene therapies to clinical trial locations, what specific needs and challenges should be considered, and how can they be effectively addressed?

How is the space evolving in terms of the ability to leverage platforms – for instance, in the area of platform assay development – and what are some keys to capitalizing on the benefits this offers?

‘Right first time’ is a key aspect of the Catalent approach – can you pick out some specific areas where this is particularly important?

Can you discuss some examples of successful simplification strategies in gene therapy manufacturing, and how they have positively impacted efficiency and reliability?