Rockville, MD. Rise Therapeutics announced today that they have successfully initiated operations of their GMP manufacturing facility based in Rockville, MD. Funding to help set up this GMP manufacturing operation came from the National Institute of Health (NIH) Commercialization Readiness Pilot (CRP) Program Grant, which 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. Launching of operations for this facility was also supported by the financial contributions of the Montgomery County Economic Development Corporation.
For this initial buildout phase, Rise has dedicated one of its two laboratories to GMP manufacturing and GMP analytical testing, which will support production, release, and stability testing of clinical product. The facility will allow Rise to carry out strain engineering, process development, analytical characterization, and clinical GMP manufacturing of microbial-based products, including Live Biotherapeutic Products (LBPs) and microbiome-based medical food products. With its emphasis on its Flexible Clean Space ManufacturingTM operations, the new facility has the following attributes:
- For GMP drug substance production, this facility is equipped with a fully-closed production system consisting of microbial fermentation up to the 100L scale, TFF-based filtration and concentration, lyophilization at the full scale, and milling and blending. All operations are capable of being executed under aerobic or anaerobic conditions throughout the process.
- Processes utilize single-use approaches such as disposable bioreactors, disposable flow paths, and disposable filtration media that couples with our advanced strategies to purify and concentrate bacterial masses with precision.
- For analytical assays used to release GMP product and perform stability assessments, the laboratory is equipped with all the required instruments that are validated for their purpose and carry supporting documentation such as SOPs and Protocols.
- Using GMP validated equipment, the facility can perform excipient blending for purposes of drug product production. These blends can support further GMP manufacturing or development studies with the encapsulation of drug product.
- Capsule Drug Product is also manufactured in this space, and Rise has equipment for hard-shell capsule encapsulation and the associated analytical units for release testing, including tap density, disintegration, and dissolution.
“Since it can be prohibitively expensive for small startup companies and academic labs to use traditional CMOs, as it can be quite costly to contract these activities, we have made extra capacity for the GMP production facility available to other groups as a better avenue to support their product development interest for microbial-based products,” stated Dr. Fanger, CEO and President of Rise Therapeutics.
“With the increasing use of beneficial microbes in the context of disease management and treatment, there is a keen focus being applied at Rise to develop these microorganisms as drug candidates. In doing this, we are raising the bar in terms of lot-to-lot consistency in product quality and making enormous strides in defining the underlying methods with which to define this product quality. By applying such fundamental drug development principles to this emerging space of Live Biotherapeutic Products and medicinal microbiome-based foods, we are building a strong foundation to be a leading developer and producer of microbial related products. We have a strong team of engineers and scientists who lead the charge in advancing our philosophy into GMP-ready processes”, added Sathya Janardhanan, Vice President of Development and Manufacturing.
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.