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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.
Clearside Biomedical, Inc. is a clinical-stage biopharmaceutical company developing first-in-class drug therapies to treat chronic, blinding diseases of the eye.
At Runatek, were ending the Opioid Crisis with innovative technology
NewLink Genetics is a biopharmaceutical company focused on discovering, developing, and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer. Founded more than 15 years ago, NewLink Genetics continues to be at the forefront in immuno-oncology treatments led by a diverse group of industry professionals and physician-scientists. Personal cancer stories inspire our relentless research and development in advancing treatments. Our grand passion is to change the cancer treatment paradigm and make a difference in patient lives every day.
Homepage for InnerScope Hearing Technologies, a hearing care company who sells Direct-to-Consumer Hearing Aids.