The ability to develop ADCs by combining protein formulation and process know how with cytotoxic drug expertise puts ProJect Pharmaceutics in a unique position within the biopharmaceutical industry.
ProJect Pharmaceutics is an ADC formulation company / ADC lyophilization company which operates ADC process development since many years. ProJect Pharmaceutics has been processing ADC molecules in its own dedicated cytotoxic safety laboratories for > 13 years, the company has worked on all generations of ADCs from 1st, 2nd, 3rd towards next generation now. We have developed over 25 ADCs for international top players in the pharmaceutical industry.
Most ADCs have a lower thermodynamic and colloidal stability due to the attachment of hydrophobic drug moieties leading to modified charge pattern and stronger hydrophobic interactions. Reduced solubility and a pronounced tendency to aggregation / denaturation may be the consequences, in particular in case of higher drug antibody ratios (DARs).
ProJect Pharmaceutics´s Predictive Formulation Analytics is the proven technology to quickly and reliably identify promising formulation candidates for ADCs and to overcome drug specific stability issues. This systematic and innovative scientific approach delivers optimized formulations for ADCs and reduces the need for extensive stability testing. Predictive Formulation Analytics complies with quality-by-design according to ICH.
Tailored to these optimized formulations the influence of process parameters in freeze drying on the critical quality attributes of the drug in its formulation will be reliably determined. The company operates a rational design of robust and efficient manufacturing processes and freeze-drying cycles tailored to the formulation and transfers those from its pilot labs to GMP.
The company not only provides specific solutions for the ADC, but alongside also takes care on development of intermediate mAb and linker payload moieties.
Intermediate mAb bulk formulation development:
Intermediate linker-payload bulk development: