03.08.25 -- Cell & Gene Best Of February

Join Cell & Gene Live for an exclusive look at cutting-edge manufacturing technologies revolutionizing cell therapy production. Our expert panel will explore organoids, 3D cultures, automation, and scalable solutions to streamline processes and enhance efficiency. Gain insights into the latest innovations driving the future of cell therapy. Registration is free thanks to the support of CPC and MaxCyte.

The FDA released final guidance on the Advanced Manufacturing Technologies Designation Program at the end of December. This article shares a summary, analysis, and how it compares to the 2023 draft.

This article explores how the disparity between the number of CDMOs and CGT clinical trials came about and how the market for manufacturing services will change as a result.

The company is starting small with a pilot to do what most companies avoid altogether — innovating the manufacturing process for a product already on the market.

The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, and CMC considerations.

The revised Annex 1 focuses on harmonizing regulations across the pharmaceutical manufacturing industry, prompting the pharmaceutical industry to strategize to achieve the best compliance method.

Advancements in genetic therapy are revolutionizing the treatment of neurological diseases, with promising results from preclinical studies leading to clinical trials focused on safety and efficacy.