Process development scientists work side-by-side with clients to optimize upstream and downstream processes intended for the robust cGMP manufacture of viral vectors at commercial-ready scales, and the bioprocessing of autologous and allogeneic cellular therapies such as CAR-T cells, TILs, TCRs and regenerative medicine cellular products.
Testing and Analytical Services
To complement process development and manufacturing operations, The Center for Breakthrough Medicines provides extensive analytical development and testing capabilities for advanced therapies and biopharmaceuticals. With parallel tracking methods in place CBM offers on-site access to testing capabilities resulting in accelerated development and manufacturing timelines. CBM Testing platforms support:
- Analytical Test Development & Assay Transfers
- Process Development Testing (R&D)
- In Process & Release Testing (GMP)
- Raw Material Testing (GMP)
- Safety & Characterization Testing (GMP)
- Stability Programs & Storage
- Custom Assays & Assay Validation
The Center for Breakthrough Medicines offers an on-site, scalable end-to-end solution for clients with plasmid capabilities. Plasmid manufacturing services include all necessary resources to support cell and gene therapy programs from pre-clinical through commercial cGMP.
Adeno-associated viral (AAV) vectors play a central role in the delivery of gene therapies and as a vehicle for gene editing approaches. The Center for Breakthrough Medicines offers a full range of AAV production scales and platforms to serve the research, preclinical, clinical and commercial manufacturing clients including:
- Transient transfection in both adherent and suspension cells
- Baculovirus and other viral co-infection methods
- Producer cell lines
- Single-use technologies for streamlined clinical development processes
- Testing and product characterization using next-generation analytical methods
Lentiviral and retroviral vectors have relatively large payload capacities. They can transfect dividing and non-dividing cells for CAR-T cell therapy development which gives them potential to serve as stand-alone vectors for gene therapy.
The Center for Breakthrough Medicines offers scalable vector production for research, preclinical, clinical and commercial manufacturing clients. Cutting-edge single-use technologies support rapid process development efforts with access to extensive testing and product characterization expertise and capabilities via next-generation analytical methods.
Co-located process development, testing, characterization, and commercialization support services help ensure successful delivery of clinical and commercial material for our clients.
The Center for Breakthrough Medicines offers a full range of production support from research into preclinical, clinical and commercial manufacturing phases. Cutting-edge manufacturing platforms leveraging single-use technologies support rapid development and production efforts across scales. Next generation analytical methods for testing and product characterization round out an unparalleled combination of co-located services for clinical and commercial success.
The Center for Breakthrough Medicines provides clients with capabilities for the manufacture of cGMP Master Cell Banks (MCB), Working Cell Banks (WCB), Master Viral Banks (MVB), and Working Viral Banks (WVB).
On-site testing for the release and characterization of these banks allows for a streamlined and accelerated availability of these critical starting materials.
The Center for Breakthrough Medicines features customizable manufacturing suites staffed by industry experts. Workflows and equipment configurations are aligned to develop and produce innovative advanced therapies. Flexibility is built into each process to meet client-specific needs.
For autologous products, we employ the most sophisticated scheduling, supply chain and inventory control systems aligned with in-process testing, quality control, and lot release programs to overcome manufacturing challenges.
For allogeneic products, well-characterized cell banks may be scaled-up with adherent systems or single-use bioreactors to meet the clinical and commercial demand for cell products at significant scale.
Our manufacturing capabilities include but are not limited to the following:
- Autologous and Allogeneic CAR-T cells
- Tumor infiltrating lymphocytes (TILs)
- Enhanced T-Cell receptors (TCRs)
- Stem cell therapies and induced pluripotent stem cells (iPSCs)
- Tumor cell vaccines
- Dendritic cell and NK cell adoptive Immunotherapies