Highly Potent APIs
The increasing focus on high-potency active pharmaceutical ingredients (HPAPIs) in pharmaceutical development pipelines, driven by the demand for oncology drugs, has led to a growing requirement for the capability to safely handle and contain these hazardous ingredients. Many CDMOs claim to be able to handle HPAPI manufacturing, but relatively few can legitimately manage the hazards associated with the complex production challenges.
At Cambrex, we have been reliably developing and manufacturing high-potency APIs and compounds for years, including immunosuppressants, cytostatics/protein kinase inhibitors, ultra-potent cytotoxic drug substance, drug linkers, PEG and cyclodextrin polymeric conjugations and toxins for antibody drug conjugates (ADCs). At our High Potency Development Center (HPDC) in Charles City — a controlled-access facility with barrier isolation, airlocks and cascading air differentials equipped to handle low ng/m3 occupational exposure limits (OELs) — we can develop a range of HPAPIs, including compounds classified as ultrapotent. Our HPDC houses cross-functional high-potency teams, including experts in chemistry and toxicology, who will work closely with your development team to ensure that we can safely and effectively develop and manufacture your compound.
Our cytotoxic, cytostatic and controlled substances capabilities include:
- Highly regimented safety protocols
- Controlled access to all areas
- Best-in-class barrier isolation
- Process development
- Scale-up of toxicology lot to commercial quantities in a cGMP environment
- Development and manufacturing of high-potency APIs to < 10 ng/m3 OEL
- Lab scale cGMP manufacturing up to 20 L
- cGMP kilo lab up to 150 L
- cGMP pilot plant
- Commercial manufacturing up to 16,000 L
- Multipurpose solids-handling suite
- cGMP micronization facility