Featured News
pHelper: Simplifying Your Gene Therapy Supply Chain
Fit-for-purpose, off-the-shelf helper plasmid streamlines manufacturing
Immediately available and ready-to-use in GMP, High Quality (HQ), and Research grade, our pHelper offering is designed to secure consistent quality supply and streamline adeno-associated virus (AAV)-based gene therapy programs from early discovery through commercial manufacturing.
Helper plasmids are the latest in a comprehensive collection of contract development and manufacturing organization (CDMO) products and services developed to simplify complex supply chains and safeguard viral vector packaging in cell and gene therapy programs. The plasmids are reliably manufactured and released according to batch production records, with Chemistry, Manufacturing, and Controls (CMC) support and a Certificate of Analysis (COA) to underwrite regulatory filings and approval applications.
When using standard off-the-shelf plasmids, such as pHelper, AAV-based gene therapy developers can both accelerate production timelines and reduce costs while leveraging significant features and benefits, including:
In stock, ready to use helper plasmid available
Reliable production process, material, and personnel controls
Compliant with current regulatory guidelines
Reduces contamination risk and supports 3Rs
Cost saving from clinical to commercial applications
Supported multiple regulatory filings
“We are committed to supporting advanced therapy developers with a rapid supply of critical plasmid DNA starting materials to expedite their programs,” explains Andrew Frazer, PhD, Associate Director, Scientific Solutions, Gene Therapy CDMO Services. “The addition of in-stock packaging plasmids for RG, HQ, and GMP grade plasmids, combined with Charles River’s established plasmid and viral vector CDMO capabilities, will help to both accelerate timelines and ensure the highest quality product with one partner.”
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 significantly reduces plasmid production turnaround time for advanced therapy medical product (ATMP) and vaccine developers.
Join Andrew Frazer to explore how manufacturing advancements can accelerate your program through established platform approaches, off-the-shelf products, and supply chain simplification.
Watch On-Demand
Gene Therapy Spotlight Launch
“The launch of Charles River’s pHelper plasmids are the first in the off-the-shelf plasmid product portfolio aimed at supporting AAV-based gene therapy programs,” commented Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions, in a press release announcing the launch. “By reducing program development costs and simplifying supply chains, pHelper will help accomplish our ultimate goal of delivering safe, effective therapies to patients faster.”
The gene therapy product was formally introduced by Andrew Frazer, PhD, Associate Director, Scientific Solutions, during an invite-only showcase event on March 13, Gene Therapy Spotlight: Investment, Regulatory and Development Perspectives, held in conjunction with the Advanced Therapies Congress, London, UK.
For more information on our plasmid DNA and comprehensive cell and gene therapy development and manufacturing services, please visit: Cell and Gene Therapy CDMO Solutions.
Join us and gene therapy developer Purespring Therapeutics to explore common challenges and regulatory guidance for sourcing plasmid DNA to support long-term program delivery and how to set yourself up for success when working with CDMOs.
Watch On Demand