Introducing formulation and lyophilization process development for cytotoxic and other highly potent drugs, including cytotoxic drug immunoconjugates (antibody drug conjugates, ADCs).
We offer pharmaceutical development of ADCs and other cytotoxic drugs in our new safety laboratory with predictive analytical methods and high-end freeze drying capabilities implemented.
The ability to develop Antibody Drug Conjugates (ADCs) by combining protein formulation and process know how with cytotoxic drug expertise puts ProJect Pharmaceutics in a unique position within the biopharmaceutical industry. Our safety facilities in dedicated labs and a profound understanding of the challenges when processing highly potent drugs enable us to provide specific solutions for ADCs and other cytostatic agents.
Many pharmaceutical ingredients of this class show limited solubility in water and rapid degradation during compounding, filling and freeze-drying. ADCs in particular have a lower thermodynamic and colloidal stability due to the attachment of hydrophobic drug moieties leading to modified charge patterns and stronger hydrophobic interactions.
Reduced solubility and a pronounced tendency to aggregation and denaturation may be the consequences, in particular in case of higher drug antibody ratios (DARs).
PJP´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.
PJP’s long lasting experience and comprehensive know-how of lyophilization from various kinds of solvent systems, as well as liposome encapsulation, enables our customers to follow new paths in formulation and process technology for modern cancer drugs.