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
Droplet Digital PCR and Digital PCR
Mass Spectrometry
Empty vs Full Capsid, Partial Characterization
Bioassays & Potency Package
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.

Explore Our Assay Tables
AAV Vector
Release, in-process, characterization
- Vector Genome Copy Titer
- Residual DNA
- Rapid Mycoplasma
- Residual Plasmid
- Infectious Titer Assay
- Residual Host Cell Protein
- Residual DNAses
- Residual Ligand
- Endotoxin
- Purity
- Residual BSA
- Total Protein (BCA)
- Capsid ID
- Residuals and characterization
- pH
- Appearance
- Osmolality
- Bioburden
- Aggregation & Particle Sizing
Advanced Analytics & Extended Characterization
- Proteomics
- Deamidation
- Rapid Mycoplasma
- Capsid ID
- Identity, characterization
Safety Testing
- rcAAV
Lentiviral Vector
Release, in-process, characterization
- Residual DNA
- Rapid Mycoplasma
- Residual Host Cell Protein
- Residual Ligand
- Residuals and characterization
- Appearance
- Bioburden
- Purity
- Residual Plasmid
- Residual Plasmid DNA
- Residual DNAses
- p24 ELISA
- pH
- Osmolality
- Endotoxin
Advanced Analytics & Extended Characterization
- Identity
- Characterization
- Next Generation Sequencing
Plasmids
Release, in-process, characterization
- Rapid Mycoplasma
- Residual DNA
- Residual Host Cell RNA
- Appearance
- Purity (% Supercoiled DNA)
- DNA concentration
- Residual Host Cell Protein
- pH
- Endotoxin
- Total Plasmid (AGE)
Advanced Analytics & Extended Characterization
- Plasmid Sequence (NGS or Sanger)
- Characterization
Cell Therapy
Release, in-process, characterization
- Vector Copy Number
- Flow Cytometry
- Characterization
- Endotoxin
- Transduction Efficiency (Flow Cytometry)
- Transgene ID
- Appearance
- Gram Stain
Safety Testing
- Sterility (Rapid Sterility)
- Mycoplasma (Rapid Myco)
Stability Studies
According to ICH Guidelines
- Accelerated degradation
- -20°C
- +15°C to +25°C
- -80°C
- +2 to +8°C
Contact us to discuss how CBM’s integrated capabilities can support your program
Viral Vector Manufacturing
CBM’s viral vector capabilities efficiently and consistently delivers high yields in AAV, Lentivirus, HSV and Adenovirus vectors, accelerating the development of new therapies.
Cell Therapy Manufacturing
CBM has one of cell therapy’s most experienced teams and the largest single site facility in the industry. There is no greater centralization of expertise.
Our Experienced Team
Our team brings a wealth of experience from biopharma and advanced therapy CDMOs, ensuring that there is no safer place for your product.