Center for Breakthrough Medicines Offers Pre-clinical Packages with Plasmids, Cell Line, and Pre-clinical Vector Manufacturing with Capacity Available Now
Comprehensive Offering Delivers Higher Quality Material & Regulatory Support for INTERACT and Pre-IND Meetings
The Center for Breakthrough Medicines (CBM), a contract development, manufacturing, and testing organization (CDMO) is packaging their pre-clinical capabilities into an IND-enabling offering to help innovator companies manufacture high quality drug substance and drug product for pre-clinical studies needed for IND-enabling activities.
Pre-clinical assessment of investigational cell and gene therapy products is a critical milestone to move programs forward while balancing limited capital allocated to this R&D stage. The importance of high-quality pre-clinical material for IND-enabling studies is often underestimated, leading to programs not having the data required to get their IND accepted and limited cash and resources to redo studies.
CBM’s IND-enabling pre-clinical package will deliver end-to-end support for pre-clinical studies and includes complimentary off-the-shelf AAV rep-cap and helper plasmids, custom plasmid manufacturing, access to a proprietary cell line, streamlined process development services, scalable pre-clinical vector manufacturing services as well as regulatory support for INTERACT and Pre-IND meetings. This package enables therapeutic developers to generate high quality material and data in under five months and positions them to move rapidly towards IND approval and GMP clinical manufacturing.
CBM’s holistic pre-clinical offerings will supply drug substance and drug product for proof-of-concept, toxicology, safety, biodistribution studies, method development, interim reference standard, development stability, and drug product development critical for IND packages. Additionally, these productions utilize similar processing techniques as would be used for GMP manufacturing, eliminating comparability risks associated with process changes. Additional analytical testing and regulatory services are available to prepare data briefing packages for INTERACT and Pre-IND meetings. Upon pre-clinical manufacturing completion, clients have full transparency to the data from execution, production, and purification, a critical data set for the sponsor of any clinical program
“The past year has been a catalyst moment for gene therapies with approvals for AAV- and LV- based gene therapies driving renewed momentum in the pre-clinical pipeline,” said Avi Nandi, CBM’s Chief Technical Officer. “CBM’s pre-clinical program will help the next generation of gene therapy companies learn from the lessons of the last five years and lay a smoother path through clinical trials and regulatory submission.”
Visit https://breakthroughmedicines.com/process-development/ to learn more.
For highlights of pre-clinical capabilities up to 500L, see CBM’s presentation BioInsights Webinar – Ensure First-time Right GMP Production of Gene Therapies, now available for on-demand streaming.
About Center for Breakthrough Medicines (CBM)
The Center for Breakthrough Medicines (CBM) is a cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, manufacture and market life-saving therapies and treatments on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM has assembled the most accomplished cell and gene therapy experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, best-in-class pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities.
Purpose-built and patient-driven, CBM was designed from the ground up to be a more-effective CDMO; providing single-source, end-to-end solutions to deliver true partnership and unprecedented value to its customers through teamwork, transparency and speed-to-market dedication.