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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 team’s work ensures quality, potency and safety 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
  • Sequencing
  • Molecular Biology
  • Microbiology – Compendial Testing and Environmental Monitoring
  • Virology
  • Stability Programs

Advanced Analytical Techniques

Next-Generation Sequencing

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, accurately measured molecular weight, quantitation of viral protein and ratios, and glycan profiling of viral proteins and host cell proteins.

Empty vs Full Capsid, Partial Characterization

Quantitation 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 vector, lentiviral vector, plasmid DNA & nucleic acids, and cell therapy service 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 BSA
  • Residual DNA
  • Total Protein (BCA)
  • Rapid Mycoplasma
  • Capsid ID
  • Residual Plasmid
  • Residuals and characterization
  • Infectious Titer Assay
  • pH
  • Residual Host Cell Protein
  • Appearance
  • Residual DNAses
  • Osmolality
  • Residual Ligand
  • Bioburden
  • Endotoxin
  • Aggregation & Particle Sizing
  • Purity

Advanced Analytics & Extended Characterization

  • Proteomics
  • Capsid ID
  • Deamidation
  • Identity, characterization
  • Rapid Mycoplasma

Safety Testing

  • rcAAV

Lentiviral Vector

Release, in-process, characterization

  • Residual DNA
  • Residual Plasmid
  • Rapid Mycoplasma
  • Residual Plasmid DNA
  • Residual Host Cell Protein
  • Residual DNAses
  • Residual Ligand
  • p24 ELISA
  • Residuals and characterization
  • pH
  • Appearance
  • Osmolality
  • Bioburden
  • Endotoxin
  • Purity

Advanced Analytics & Extended Characterization

  • Identity
  • Characterization

Plasmids

Release, in-process, characterization

  • Rapid Mycoplasma
  • DNA concentration
  • Residual DNA
  • Residual Host Cell Protein
  • Residual Host Cell RNA
  • pH
  • Appearance
  • Endotoxin
  • Purity (% Supercoiled DNA)
  • Total Plasmid (AGE)

Advanced Analytics & Extended Characterization

  • Plasmid Sequence (NGS or Sanger)
  • Characterization

Cell Therapy

Release, in-process, characterization

  • Vector Copy Number
  • Transduction Efficiency (Flow Cytometry)
  • Flow Cytometry
  • Transgene ID
  • Characterization
  • Appearance
  • Endotoxin
  • Gram Stain

Safety Testing

  • Sterility (Rapid Sterility)
  • Mycoplasma (Rapid Myco)
  • Replication Competent Lentivirus
  • Mycoplasma (Rapid Myco)

Stability Studies

According to ICH Guidelines

  • Accelerated degradation
  • ≤80°C
  • -20°C
  • +2 to +8°C
  • +15°C to +25°C