Analytical Development & Testing Services
The Center for Breakthrough Medicine (CBM) provides Analytical Development and Testing including analytical method development, method transfers, qualification and validation services. Our approach encompasses the FDA domains of safety, potency, purity, stability, and identity throughout product development and manufacturing, with the ultimate goal of safeguarding patients.
Our testing services occupy 200,000 square feet of GMP laboratory space, located on one campus to provide clients with access to capabilities and direct support without having to outsource to multiple laboratories.
CBM also offers production of GMP Master and Working Cell Banks, as well as Master and Working Virus Seed Stocks. Characterization and release testing is also offered as part of CBM’s banking services.
Testing services include:
- Analytical Development, Method Qualification and Validation
- GMP Characterization, In-Process and Lot Release Testing
- Rapid Release Programs
- Process Development R&D Support
- Cell-Based bioassays
Release, in-process, characterization
Vector Genome Copy Titer
DNA and RNA sequencing, plasmid sequencing, individual cell characterization identification of rare populations not detectable in pools, viral sequence integration verification, and analysis of on- and off-target effects.
Droplet Digital PCR and Digital PCR
Robust and accurate quantification of plasmid quality, viral titer, vector copy number, percent modified cells, and residual host DNA.
Mass Spectrometry
Peptide mapping, molecular weight measurement, quantification of viral protein and ratios, and glycan profiling of viral proteins and host cell proteins.
Empty vs Full Capsid, Partial Characterization
Quantification of empty, partial, and full capsid ratios, identification of impurities affecting product quality, therapeutic effect, and safety.
Bioassays & Potency Package
Cell-based bioassays for multiple cell lines, virus product strength, infectivity / media tissue culture infections dose (TCID50), translation potency, polypeptide chain expression, and functional protein potency.
Testing Platform & Capabilities
Product release analytical testing panels are customized for each AAV & lentiviral vector, plasmid DNA & nucleic acids, and cell therapy program. CBM also offers the capability to support biologics, vaccines and other advanced therapies.