ADC Cytotoxic Drug Development
As one of the few antibody drug conjugate companies that offer CRO development services on cytotoxics, we offer pharmaceutical development of antibody conjugated drugs (ADCs) and other cytotoxic drugs in our dedicated 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 high potency cytostatic agents.
Many pharmaceutical ingredients of this class of small molecule drugs 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).
ADC formulation and ADC process development: 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. Following this customized antibody drug conjugate characterization by physico-chemical methods, process development towards a stable liquid or lyophilized drug product will be evaluated.
Cytotoxics: PJP’s long lasting experience and comprehensive know-how of lyophilization from various kinds of solvent systems, as well as liposome encapsulation (more information under: Drug Formulation Development), enables our customers to follow new paths in formulation and process technology for modern cancer drugs.
