UNITE
DEVELOP
Your Trusted Partner for the Next Generation of Advanced Therapies
MANUFACTURE
BREAKTHROUGH
THE CBM DIFFERENCE
Capacity at Scale
Center for Breakthrough Medicines (CBM) is an advanced therapy
We offer turnkey expansion with modularly-designed and BLA-ready suites for high throughput and maximum yield.
patients that need them. Our end-to-end capabilities include plasmid
Single-Site CDMO
focused CDMO dedicated to delivering life-changing treatments to the DNA, viral vector manufacturing, and cell therapy production from
pre-clinical to commercial scale, with drug substance, drug product, and
analytical services all at a single site. Our team leaders were involved in
commercializing the first cell & gene therapies at leading biopharmas and CDMO’s, and are ready to help guide your innovations from concept to clinic to commercial.
Our capabilities are co-located on a single campus for seamless hand- off between development, manufacturing, and testing.
Expert Team & Partners Our leaders, hailing from top-tier CDMO’s and biopharmas, were involved with bringing the first cell and gene therapies to market, and our academic partners are pioneers in the field.
CAPABILITIES & CAPACITY AT A SINGLE-SITE
Flexible Ways of Working Viral Vector Suites
Cell Therapy Suites
Analytical Assays
We are willing to put skin in the game with flexible terms and milestone-based arrangements.
Integrated Analytical Capabilities THE ONLY FULLY INTEGRATED, END-TO-END PLATFORM
Cutting-edge analytical infrastructure and techniques enable us to rapidly get the critical answers around safety, efficacy, and potency.
FOR ADVANCED THERAPIES R&D
Process Development
Viral Vectors
Plasmid DNA
Cell Therapy
Cell Banking
Analytical Testing
Quality & Regulatory
Customizable Solutions www.breakthroughmedicines.com
Purpose-Built GMP Manufacturing Clinical and commercial GMP manufacturing with end-to-end capabilities from process development through drug substance manufacturing and drug product filling are supported with full testing capabilities.
UNITE
DEVELOP
MANUFACTURE
Process Development
BREAKTHROUGH
Viral Vectors
FULLY INTEGRATED, END-TO-END PLATFORM FOR
FULLY INTEGRATED CAPABILITIES
Plasmid DNA
ADVANCED THERAPIES
Analytical Testing
Research & Development
Cell Therapy
Quality & Regulatory
We provide an innovator company approach to vector and
process design. Our experts assess manufacturability early on
and mitigate risk during development to support the successful and rapid scale-up of high-quality advanced therapies.
Process Development Our experienced team will work side-by-side with yours to optimize upstream and downstream processes for cGMP
Cell Therapy Manufacturing
therapies. We support development through plasmid vector
workflows support autologous products with sophisticated
manufacture of viral vectors and autologous or allogeneic cell
In over 20 cell therapy suites, our flexible equipment and
selection, cell line selection, cell banking, formulation and drug
scheduling and supply chain management, and allogeneic
product development, and process optimization.
products scaled up in adherent and suspension systems.
Plasmid DNA Manufacturing
Cell Banking
Our production capabilities include plasmid DNA and other
CBM offers clients the capability to manufacture cGMP
therapeutics. We have full resources available to support cell
Viral Banks (MVB), and Working Viral Banks (WVB). Integrating
nucleic acids that form the genetic foundation for many
Master Cell Banks (MCB), Working Cell Banks (WCB), Master
and gene therapy programs and rapidly progress them from
this process, including characterization and release services,
R&D to cGMP production.
ensures the safety and longevity of the crucial cell line.
Analytical Development & Testing
Viral Vector Manufacturing
Our Analytical Development and Testing capabilities occupy
With one of the world’s largest single-site viral vector facilities,
efficiently located to be seamlessly integrated with production.
production of Adenovirus, AAV, Lentivirus, and other viral- based
200,000 square feet of lab space on our campus, and are
We provide method development, method transfer, qualification and validation to ensure quality, potency and safety.
Center for Breakthrough Medicines
we have over 20 cGMP suites modularly designed for scalable therapeutics. Clients also have the option to utilize a proven platform licensed from the lab that pioneered gene therapy.
Email: info@cfbm.com www.breakthroughmedicines.com
411 Swedeland Road King of Prussia, PA 19406