Rise Therapeutics Prepares for Internal GMP Manufacturing Supported by the NIH’s Commercialization Readiness Program
Rockville, MD. Rise Therapeutics announced today that they have received funding associated with the National Institute of Health (NIH) Commercialization Readiness Program (CRP), enabling Rise to establish in house GMP manufacturing capabilities. The NIH’s CRP assists small businesses with technical assistance and late-stage development projects that are not typically supported by SBIR and STTR Phase II and Phase IIB grants or contracts.
With this funding, Rise will be dedicating a substantial portion of its lab space to GMP manufacturing and analytical testing. The facility will allow Rise to develop and produce first-in-class GMP products in the microbial and Live Biotherapeutic Product (LBP) space. Rise Therapeutics will utilize its Flexible Clean Space ManufacturingTM configuration to advance its own drug pipeline and products it supports for its partners. The infrastructure can be used for production of GMP master cell banks, drug substance, and drug product. In addition, the facility will be sufficiently equipped to support analytical testing used to release GMP product and for long-term stability assessment.
“We are grateful to have the support of the NIH’s Commercialization Readiness Program. GMP manufacturing is an expensive process for small businesses, and we are excited to be able to move forward in building out this facility,” said Dr. Gary Fanger, CEO and President of Rise Therapeutics. “Rise is focused on developing immunological-based biological medicines using a unique and proprietary oral biologics delivery platform. With this infrastructure build out, we will now be able to more efficiently transition these programs through clinical validation with our internal clinical GMP manufacturing infrastructure.”
Dr. Fanger has been involved with clinical GMP manufacturing facility buildouts previously. These prior GMP manufacturing facilities supported product translation of NIH-funded discoveries and launched multiple drug candidates into clinical trials. Dr. Christian Freguia, newly hired at Rise Therapeutics as VP of Research and Manufacturing, has led GMP manufacturing for both small molecule and biologic drug candidates, which resulted in impressive final yields and passed release specification to enable dosing in Phase 1 trials. With this level of expertise alongside the support of multiple ex-FDA CMC consultants who are advising Rise on their manufacturing approach, Rise’s state-of-the-art GMP production facility will add importantly need manufacturing capacity for microbial based products.
About Rise Therapeutics
Rise Therapeutics is an emerging, privately held company located in Rockville, Maryland which leverages its expertise in synthetic biology and immunological drug development to create novel cellular-based immune therapies. With a strong emphasis on product development and its internal clinical GMP manufacturing infrastructure, Rise is focused on developing immunological-based biological medicines using a unique and proprietary oral biologics delivery platform. Unlike traditional biological therapies which require injection or infusion, Rise Therapeutics’ delivery platform allows simple, convenient, and cost-effective oral capsule delivery of targeted protein therapy. Our drug development focus is driven by new microbiome-related discoveries enabling development of targeted, first-in-class immune modulatory drugs for the treatment of inflammation, autoimmunity, cancer, and infection. In the context of its expertise in synthetic biology medicine, proprietary TPX oral drug delivery platform, and clinical GMP manufacturing capabilities, Rise is creating and rapidly advancing life changing cellular-based medicines to the market. For more information, go to www.risetherapeutics.com.