Analytical Development
& Testing Services
The Center for Breakthrough Medicine’s Analytical Development and Testing team provides analytical method development, method transfers, qualification and validation services to ensure quality, potency and safety throughout product development and manufacturing with the ultimate objective of safeguarding end-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.
Laboratories & 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
- Virology
- Microbiology – Compendial Testing and Envirornmental Monitoring
- Sequencing
Advanced Analytical Techniques
Next-Generation Sequencing
aDNA 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
precise, robust, accurate, and absolute quantification of plasmid quality, viral titer, vector copy number, percent modified cells, and residual host DNA.
Mass Spectometry
peptide mapping, accurately measure molecular weight, quantitation of viral protein and ratios, glycan profiling of viral proteins and Host Cell Proteins.
Empty vs Full Capsid, Partial Characterization
quantitate empty, partial, and full capsid ratios, identify impurities affecting product quality, therapeutic effect, and safety.
Bioassays and Potency Package
cell-based bioassays for multiple cell lines, virus product strength, infectivity / media tissue culture infections dose (TCID50), translation potency, polypeptide chain expression, functional protein potency assay.
