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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.
Mirum Pharmaceuticals (NASDAQ: MIRM) is dedicated to creating life-changing therapies for patients with liver diseases. We are advancing our lead product candidate for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC) — conditions with a profound and devastating impact on quality of life for young patients and their families. Untreated, these conditions can lead to liver failure and inflict life-altering symptoms including stunted growth and severe, non-stop itching. Under current standard of care, patients often require a liver transplant and are at higher risk of many serious health issues. Working closely with patients and caregiver communities, we intimately understand the challenges of living with cholestatic liver diseases. Based on a wealth of data from clinical trials spanning multiple years and involving more than one hundred patients, we believe our approach can address the underlying cause of symptoms and liver damage. Our goal is to give families their lives back.
New Health Sciences is developing Hemanext, a technology designed to improve the safety and efficacy of transfusion therapy through novel storage methods.
ZEST Dental Solutions has been manufacturing overdenture implant attachment systems as a global leader and being one of the top dental implant manufacturers for over forty years.
Our mission is simple: we are focused on changing the world for children with autism. Learn more about our ABA Services.