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Analytical Development & Testing Services for Advanced Therapies

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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.

Center for breakthrough medicines cell therapy analytical development and testing team member

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, reducing sample volumes needed by up to 50%.

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 in under 6 weeks
  • Rapid Release Programs – same day for Core Labs
  • Process Development R&D Support
  • Cell-Based bioassays
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Release, in-process, characterization testing

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.

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Center for breakthrough medicines team member viewing cell-based bioassay results

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