 |
Formulation Development
CMC Biologics offers formulation development services integrated as part of a comprehensive development and manufacturing program, but also as standalone services. CMC has experience developing both liquid and lyophilized formulations for a wide range of proteins, including monoclonal antibodies and Fc fusions, enzymes, growth factors, complex glycoproteins, and novel recombinant constructs.
Formulation samples are stored in monitored temperature- and/or humidity-controlled incubators. Samples may be analyzed by any of the analytical methods described on the Analytical Development page.
Lyophilized Formulation Development
Lyophilization cycle development and optimization are performed on a VirTis Genesis EL pilot freeze-dryer, which provides excellent scalability to manufacturing scale. Lyophilized samples may be analyzed by any of the analytical methods described on the Analytical Development page.
Typical Studies Performed
Stress-degradation
- 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
Preformulation
- A variety of excipients and parameters are examined under accelerated conditions to identify those providing the greatest product stability
Formulation Selection
- 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
In-use Stability
- Product stability is assessed in configurations to be used in a toxicology dose-ranging study or in the clinic
Material Compatibility
- Product compatibility is assessed with materials used in candidate container closure systems or with materials used during manufacturing
|
