Pharmaceutical DevelopmentPharmaceutical Development and Biologics
At InSymbiosis, our substantial experience in preclinical chemical optimization and chemistry, manufacturing and control (CMC) can facilitate our clients’ transition through lead optimization to the development and optimization of a clinical candidate. In addition to our chemistry related services, InSymbiosis can support our clients’ needs in the optimization, scale up and manufacture of biopharmaceutical products (proteins and antibodies).
Our experts start each program by determining the client’s exact needs, including discussion of regulatory, manufacturing and formulation strategies, as well as choice of expression system for biopharmaceutical products. Preclinical chemistry programs often begin with the development and optimization of chemical synthetic routes for the target compound followed by development of robust separation and purification strategies. Our chemical development capabilities are well supported by analytical services during this key transition period from early drug discovery to preclinical and clinical testing. Once the program is ready to consider formulation strategies, InSymbiosis works closely with a partner laboratory in order to provide dosage form development through to manufacture.
Please see our Pharmaceutical Development brochure for more details or Contact Us.