With more than 30 years' expertise in industrial scale manufacturing of APIs and over 20 years' experience in handling HPAIs according to cGMP, Cerbios is highly qualified in process development and manufacturing of New Chemical Entities with High Potency (High Potency Active Ingredients) characteristics from preclinical to commercial.
Cerbios is one of the few CMOs capable of handling Category 4 (SafeBridge®) from few grams to several kilograms under cGMP.
The long-term expertise in Biotechnology of Cerbios is paramount to an appropriate conjugation process and handling of ADCs like biologics
- Process development and manufacture of the cytotoxic drug-linker payload
- Bioconjugation and process development for the production of the drug substance with multiple scaffolds (mAbs and derivatives, wide variety of recombinant scaffolds).
Cerbios offers are tailor made and can be provided as a full package (chemistry and bioconjugation), or as stand-alone activities (payload or conjugation).
Our company can fully support all the stages of the ADC pipeline, starting from POC studies or internalizing already existing procedures for a fast track to the GMP manufacture.