Newsletter | January 25, 2023

01.25.23 -- Considerations For Partnering With A Cell & Gene Therapy CDMO

In-House Plasmid Production To Secure Supply Chains

Access to plasmid is a significant obstacle in downstream biopharma manufacturing. Capacity, manufacturing instability, and issues identified post-sequencing are important considerations for companies looking to streamline development efforts. Partnering with a CDMO that performs in-house plasmid production provides the opportunity to create efficiencies.

Navigating Analytical Requirements For GMP Viral Vectors
The keys to success are establishing appropriate strategies and fundamental testing, expecting additional regulatory requests, being prepared for assay variability, recognizing the limits of current understanding, and ensuring that comparability studies will be possible by retaining material from preclinical batch runs and stability studies.
Understanding The Gene Therapy Manufacturing Process

Gene therapy is the process of replacing damaged or unhealthy genetic material with new material for treating various diseases and conditions. Curious to learn more about the process of gene therapy manufacturing? Explore the steps that go into manufacturing a gene therapy treatment.

What To Consider When Looking To Partner With A CDMO

It’s not just about scheduling, capacity, and terms. In this Q&A, an industry expert shares his views on overlooked considerations when partnering with a CDMO and the challenges of building a new facility during a pandemic.

Looking For Scalability In Clinical Manufacturing?

Andelyn Biosciences’ current good manufacturing practices (cGMP) clinical manufacturing facility operates according to FDA cGMP guidelines and with multinational health agencies around the world. Andelyn has the capability for producing five distinct viral vector products.

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Cell & Gene Capacity Update

Andelyn Biosciences announces the launch of its third facility — the Andelyn Corporate Center clinical and commercial GMP manufacturing facility. The 250,000 square foot facility is engaged in gene therapy and viral vector manufacturing with 14 upstream rooms and a veteran staff to support Phase I to commercial manufacturing.

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