Synergy Bioscience offers formulation development consulting services integrated as part of a comprehensive development and manufacturing program, but also we can offer this service as a standalone service.
Synergy Bioscience has experience developing both solid dose, capsules, inhalation, liquid and lyophilized formulations for a wide range of small synthetic molecules and large protein molecules, including enzymes, monoclonal antibodies, growth factors, complex glycoproteins, and novel recombinant constructs.
We also provide analytical method and development consulting services as part of the development consulting services. Please see the Analytical Development page.
In addition, Synergy Bioscience can support your product development activities by offering the following studies:
Protein is subjected to stress conditions (e.g. oxidation, extreme pH, elevated temperature, freeze-thaw cycling, agitation) in order to identify product sensitivity to various stress conditions and to confirm that the selected assays are stability-indicating.
A variety of excipients and parameters are examined under accelerated conditions to identify those providing the greatest product stability
Several candidate formulations are examined under real-time and accelerated conditions, typically over a period of three months, to provide an optimized final formulation together with preliminary stability data
Product stability is assessed in configurations to be used in a toxicology dose-ranging study or in the clinic
Product compatibility is assessed with materials used in candidate container closure systems or with materials used during manufacturing.