ADC / Cytotoxic Drug Development

cytotoxic-drug-development

Formulation and lyophilization process development for Antibody Drug Conjugates (ADCs), cytotoxics and other highly potent drugs

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 new safety facilities in dedicated labs and a deep 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 degrade rapidly 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 pattern and stronger hydrophobic interactions. Reduced solubility and a pronounced tendency to aggregation and denaturation may be the consequences, in particular for 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 lyophilisation from various kinds of solvent systems as well liposome encapsulation enables our customers to follow new paths in formulation and process technology for highly potent drugs.

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