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Ready, Set, Go: Off-the-Shelf Plasmids Streamline AAV Therapies
Expediting gene therapy production timelines by up to 66%
When it comes to starting materials, quality, predictability, and availability are critical. Our reliable, ready-to-use plasmid products are manufactured and released with CMC guidance and according to batch production records, with a Certificate of Analysis (COA) to support Investigational New Drug (IND) and Clinical Trial Application (CTA) filings.
Complementing a portfolio of lentiviral packaging and AAV Helper plasmid products, the addition of AAV Rep/Cap (RC2, 5, 6, 8, 9) plasmids supplements an extensive range of contract development and manufacturing organization (CDMO) products and services, reducing manufacturing efforts by up to 66%.
"Gene therapy clients leveraging the Rep/Cap offering, combined with our established CDMO capabilities and phase-appropriate approach can expect reduced development costs, risks, and timelines while ensuring the highest quality product,” explains Andrew Frazer, PhD, Associate Director, Scientific Solutions, Gene Therapy CDMO Services.
Our Rep/Cap plasmid has been used to successfully support the production of a range of AAV serotypes carrying various therapeutic transgenes at multiple development and GMP production scales, and completes a comprehensive range of off-the-shelf plasmid products to support AAV and LVV production, plus the eXpDNA™, nAAVigation®, and Lentivation™ manufacturing platforms, established over 20 years of plasmid and viral vector CDMO track record to accelerate turnaround times.
Ignite the Path to Gene Therapy Breakthroughs
With a phase-appropriate approach in mind, our premium AAV, LVV products and services, as well as plasmid DNA products streamline your gene therapy from discovery to commercial manufacture, supporting every phase in between. Invest early in your product and gain decades of experience with us.
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Advanced Therapies Week Launch
“The launch of our off-the-shelf Rep/Cap offering is the latest in a series of portfolio enhancements designed to streamline adeno-associated virus (AAV)-based gene therapy programs,” commented Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions, in a press release announcing the launch. “The reduction in production time and improved efficacy of the supply chain will help accomplish our ultimate goal of delivering safe, effective therapies to patients faster.”
During his presentation, How to Expedite your Gene Therapy Program: Platform Manufacturing Approaches, at Advanced Therapies Week on January 17, Ramin Baghirzade, PhD, Senior Director, Global Head Commercial, Gene Therapy CDMO Services, will explore the benefits of ready-to-use products, alongside platform production approaches, to ensure speed and predictability.
In addition, Matthew Hewitt, PhD, Vice President, Technical Officer CGT & Biologics, is set to host The Future of Cell and Gene Therapy Manufacturing, Development, and Commercialization on January 18. This expert panel discussion will cover hot topics in the industry, including market access, decentralized manufacturing strategies, and the next generation of CGT production.
For more information on our plasmid DNA and comprehensive cell and gene therapy development and manufacturing services, please visit our Cell and Gene Therapy CDMO Solutions page.
Packaging Plasmids for AAV Manufacturing
Using standard off-the-shelf plasmids, such as Helper and Rep/Cap plasmid required for AAV production, offers the advantage of being immediately available, reducing development costs and simplifying supply chains.
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