Process Development
CONNECT WITH AN EXPERTThe importance of first-time right process development (PD), whether for preclinical studies or for scale-up and commercial readiness, cannot be overstated. It is critical to increasing yields, achieving product quality expectations, and lowering the cost of goods while meeting clinical development and commercial readiness milestones. We offer phase appropriate process development support from preclinical, to clinical and commercial.
The Center for Breakthrough Medicines (CBM) has a PD team with unrivaled experience building and optimizing biopharmaceutical processes for early-stage, clinical and commercial advanced therapies.

Strategic development drives flawless GMP execution

Developing Strategy
Implementing Strategy
Technology Transfer
Viral Vector Process Development
Upstream
- Suspension and adherent manufacturing platforms for Adeno-Associated Virus (AAV), Adenovirus, Lentivirus, and other novel viral vectors
- Research cell and virus banking (RCB & RVB)
- Process development - de novo or review of current process
- Pilot production to support IND-enabling studies
Downstream
- Viral vector purification capabilities across all processing steps: filtration, chromatography, and ultracentrifugation
- Process development - mitigation of scaling impact risk (yield, impurities)
- Process validation / BLA-enabling activities
- Pilot production to support IND-enabling studies
Drug Product & Analytics
- High-throughput formulation development
- Drug product process development
- Drug product characterization
- Stability and force-degradation studies
Preclinical Manufacturing
- R&D plasmid manufacturing
- Access to proprietary cell line
- Streamlined process studies
- Preclinical vector manufacturing
Cell Therapy Process Development
Drug Substance
- Process development and characterization for both autologous and allogeneic products
- Process validation / BLA-enabling activities
- Pilot production to support IND-enabling studies
- Technology transfer / GMP readiness
Drug Product
- Formulation development
- Formulation & fill process automation and closure
- Cryopreservation cycle development
- Container closure development
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.