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September 15, 2023  •  Webinar


Over the past several years, novel cell and gene therapy (CGT) products have rapidly progressed through the clinic, and several have gained regulatory approval. Advances in both cell and molecular biology as well as immunology and more efficient manufacturing paradigms have led to an explosion in new CGT products.

Gone are the days of relatively straightforward plasmid DNA and stem cell therapies. Today, new product paradigms including CAR-Ts, novel viral vectors, microbiome-derived bacterial products, phage therapies and mRNA therapies constantly provide new challenges to product developers.

What are some of the scientific, quality, and regulatory hurdles developers face with novel CGT products and how can biotech work most effectively with regulators to get these promising products into patients? Our panel will discuss some of the CMC and nonclinical challenges commonly faced with novel CGT products and how we might overcome them to bring these complex, but promising therapies to the clinic.
Listen in to Mike Grace, David Pepperl, Diana Colleluori, Robert Kutner, and Chris Scull as they discuss the challenges and some solutions.

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March 7, 2023  •  Podcast

“Understanding Cell & Gene Therapy Potency Assay Development” with Diana Colleluori

In this episode of Insight at Biologics, industry expert, Diana Colleluori, explains everything that cell & gene therapy manufacturers need to know about potency assays. Learn about the definition, FDA guidances and regulations, best practices, and how to overcome the hurdles in potency assay development on this episode of Insight at Biologics.

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October 13, 2022  •  News

CMC Business Unit Meeting

In late September, the Biologics Consulting CMC Business Unit met at the Alexandria Headquarters for an all-day team meeting. The meeting created some insightful discussion that focused on the overall CMC strategic plan and growth initiatives as well as broader company updates. After a productive meeting…

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January 28, 2022  •  Blog

The Right CMC Consultant Can Save You Time and Money

You are developing a new pharmaceutical product and think you would benefit from the services of a consultant with expertise in the Chemistry, Manufacturing, and Controls (CMC) requirements of global pharmaceutical regulatory bodies, but you also need to make the most of your CMC budget. Although CMC…

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