Resources

Andelyn's 20+ years in Gene Therapy Manufacturing provides valuable insights and resources below

Partnering for Scalable Suspension Processes Tailored to AAV Gene Therapies

The Use of a Proven AAV Platform to Drive Down Program Costs and Maximize Speed

Webinar | A robust and scalable suspension platform for AAV manufacturing

From challenge to triumph: how an experienced CDMO can supercharge your biotech journey

Coping with a Talent Shortage and Talent War in Cell and Gene Therapy

By Cyrill Kellerhals and Sarah O’Reilly, Andelyn Biosciences

Building a Bridge of Equivalence to Facilitate and Implement Rapid Process Changes in Gene Therapy Manufacturing

By Wade Macedone, Jonathan Rush, Samir Acharya, and Phillip Vermilion, Andelyn Biosciences

Optimizing Yields, Tech Transfer, and the Supply Chain for Viral Vector Manufacturing

By Andrew Moreo and Lenore Giannunzio, Andelyn Biosciences

Navigating Analytical Requirements for GMP Viral Vectors

By Will Fountain, Head of Analytical Development, Andelyn Biosciences

Leveraging Partnerships and a Unique History to Address Supply Chain

By Wade Macedone and Adam Lauber, Andelyn Biosciences

In-House Plasmid Production to Secure Supply Chains

In-House Plasmid Production to Secure Supply Chains By Kristin Heller, Andrew Moreo, and Jonathan Rush, Andelyn BioSciences

Early Plasmid Optimization For Long-Term Commercial Success

Early Plasmid Optimization For Long-Term Commercial Success By Kristin Heller, Plasmid Core Manager, and Andy Moreo, Head of Process Development, Plasmid and Viral Vector Core Facilities, Andelyn BioSciences

The Future of Viral Vector Manufacturing: Yield Optimization

The Future of Viral Vector Manufacturing: Yield Optimization By Andy Moreo, Head of Process Development, Plasmid and Viral Vector Core Facilities, and Lenore Giannunzio, Principal Research Scientist, Andelyn BioSciencesw

DMF Update

FDA has accepted Andelyn's GMP plasmid DNA drug master file (DMF), which enables the organization to vertically integrate its clients' manufacturing process, condensing timelines for developers to begin manufacturing to just three months.

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