Charles River Laboratories International, Inc. has launched its off-the-shelf pHelper offering, which is designed to secure supply and streamline adeno-associated virus (AAV)-based gene therapy programs from early discovery through commercial manufacturing. It is available in Research Grade (RG), High Quality (HQ), and Good Manufacturing Practice (GMP)-grade.
 
Helper plasmids are the latest in a comprehensive collection of contract development and manufacturing organization (CDMO) products and services developed to help simplify complex supply chains and safeguard viral vector packaging in cell and gene therapy programs. This plasmid product is manufactured and released with Chemistry, Manufacturing and Controls (CMC) information and a Certificate of Analysis (COA) to support regulatory filings and approval applications.
 
Using standard off-the-shelf plasmids such as pHelper AAV-based gene therapy developers can help accelerate production timelines. According to the company, features and benefits include:
            •          Immediate, reliable supply
            •          Fit-for-purpose, consistent quality
            •          Kanamycin antibiotic resistance
            •          Animal component-free production
            •          License and royalty-free, from research to commercial
            •          History of use in AAV production for a range of serotypes, therapeutic trans-genes, and scales
 
Plasmid DNA CDMO Services 

The addition of pHelper plasmids follows the launch of the eXpDNA™ plasmid manufacturing platform, established over decades of plasmid DNA CDMO scale-up experience, which is designed to significantly reduce plasmid production turnaround time for advanced therapy medical product (ATMP) and vaccine developers.