Blue Stream offers in-depth structural characterization services suitable for CMC Product Characterization programs. CMC Product Characterization programs are defined by the nature of the product itself, and will vary accordingly. Blue Stream will initially confer with the Sponsor regarding precisely which assays are necessary for satisfying the CMC section of their IND filing. Blue Stream is available to provide consultation and/or guidance as needed. Subsequently, Blue Stream will proceed with the laboratory and documentation activities as defined:
- Primary structural characterization services
- Secondary and higher order structural characterization services
- Pre-formulation support services
- Pre-IND Stability Program management
- Activity/potency assay development
During the execution and completion of a CMC Product Characterization program, Blue Stream gains superior understanding of the structure and activity of a particular molecular entity or product. As a result, many of our clients request that, in addition to providing a robust CMC Product Characterization program, we move into the development and qualification of analytical assays used for pilot-scale and Phase I/II in-process testing, and cGMP stability and Lot Release Programs.