Adeno-associated virus (AAV) is a popular gene therapy vector used for delivering therapeutic genes to target cells. However, producing high-quality AAV vectors at scale is a complex and challenging process, and the resulting AAV products can exhibit variability in their quality and potency. Access to a proven AAV platform process improves the consistency, reproducibility, and quality of AAV production.
AAV Adherent Platform at CBM
The Center for Breakthrough Medicines (CBM) is the exclusive CDMO partner of University of Pennsylvania’s Gene Therapy Program. The Platform’s downstream process has an average recovery of 30%, results in greater than 80% full capsids by analytical ultracentrifuge analysis and can pool up to three upstream runs into a single downstream harvest with a typical yield of 4.8E16 total GC at harvest.
CBM customers have immediate access to the manufacturing procedures developed by pioneers in the gene therapy field. The iCellis 500 Adherent Platform can facilitate the rapid manufacturing of high-quality advanced gene therapy products, having completed nearly 100 successful production scale batches and supporting manufacturing of four clinical phase programs. Learn more about the platform below.
Well-Established AAV Platform Technology
- • Production cell line
- • Production plasmids
- • Established adherent process
Advanced Platform Analytics
- • Limited assay development
- • Testing performed onsite
- • Reduced sample requirements
- • Reduced testing turn-around times
GMP Experts
- • State of the art cGMP vector manufacturing suites
- • Right-first-time execution
- • Critical reagent procurement and testing
AAV Expertise
- • Experts co-localized onsite
- • Access to next generation of AAV technology
- Well-Established AAV Platform Technology
-
Well-Established AAV Platform Technology
- • Production cell line
- • Production plasmids
- • Established adherent process
- Advanced Platform Analytics
-
Advanced Platform Analytics
- • Limited assay development
- • Testing performed onsite
- • Reduced sample requirements
- • Reduced testing turn-around times
- GMP Capabilities
-
GMP Experts
- • State of the art cGMP vector manufacturing suites
- • Right-first-time execution
- • Critical reagent procurement and testing
- AAV Experts
-
AAV Expertise
- • Experts co-localized onsite
- • Access to next generation of AAV technology
CBM Expertise
CBM is an advanced therapy CDMO dedicated to developing life-changing treatments to our customers. We offer unparalleled flexibility to work alongside our subject matter experts in development labs and GMP operations in our manufacturing suites.
Our comprehensive viral vector capabilities are fully integrated on a single campus for seamless transition between development, manufacturing, and testing. Learn more here.
Interested in discussing your advanced therapy needs?
Genesis Vector Manufacturing SolutionsTM
CBM’s vector manufacturing capabilities cut time to GMP drug product by more than half. In-house capabilities include: plasmid manufacturing, first-time right process development, high throughput vector manufacturing of drug substance and drug product, analytical and testing, regulatory, supply chain, and R&D services all at a single source.
CBM Thought Leadership
White Paper: Process Platforms vs. Custom Process Development for AAVs and Gene Therapies
