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Momenta is a biotechnology company with a product pipeline of both complex mixture generic and novel drugs. Our complex mixture generics and follow-on biologics effort is focused on building a thorough understanding of the structure-process-activity of complex mixture drugs to develop generic versions of marketed products. While we use a similar analytical and development approach across all of our product candidates, we tailor that approach for each specific product candidate. Our first objective is to apply our core analytical technology to thoroughly characterize the structure of the marketed product. By defining the chemical composition of multiple batches of a marketed product, we are able to develop an equivalence window which captures the inherent variability of the innovator`s manufacturing process. Using this information, we then build an extensive understanding of the structure-process relationship to design and control our manufacturing process to manufacture reproducibly an equivalent version of the marketed product. Where necessary, and as required by the U.S. Food and Drug Administration, or FDA, we will supplement an application with additional supportive structure-activity data (e.g., immunogenicity, pharmacodynamics). Our goal is to obtain FDA approval for and commercialize generic or follow-on versions of complex mixture products, thereby providing high quality, safe and affordable medicines to patients in need.
Resolution Medical Overview Medical Device and Component Manufacturing, Development, Testing, and other Engineering Services.
Berg Pharma focuses research on understanding how alterations in metabolism relate to disease onset. The company has a deep pipeline of early-stage technologies in CNS diseases and metabolic diseases that complement its late-stage clinical trial activity in cancer and prevention of chemotoxicity. Armed with use of the Berg Interrogative Biology™ discovery platform that translates biological output into therapeutic candidates, Berg Pharma is well positioned for rapid commercialization of its intellectual capital.
PCA Pharmacy is a Louisville, KY-based company in the Healthcare, Pharmaceuticals, and Biotech sector.