Formulation Development

Our Pharmaceutical Development team is highly skilled in the development of biopharmaceuticals including standard monoclonal antibodies, recombinant proteins, fusion proteins, antibody-drug-conjugates (ADCs) and peptides. Our experienced Pharmaceutical Development team comprises 20 scientists (>40% with Ph.D. or M.S.) and sees continual growth to meet client demand and support ongoing expansion.

Formulation development services are available for liquid and lyophilized drug product dosage form. The service offerings comprise the complete biopharmaceuticals formulation development activities:

• Pre-formulation, candidate developability assessment;
• Formulation screening and process development;
• Lyophilization process development;
• Container-closure system selection and qualification;
• Long-term and accelerated drug substance and drug product stability studies according to ICH guidelines;
• In-use stability studies;
• Extractable & Leachable testing for pharmaceutical container-closures;
• Drug product manufacturing process setup, design and process development;
• Manufacturing of pre-clinical and clinical stage drug product;
• Regulatory support for drug product sections IND documentation;