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