New Gencure Biomanufacturing Facility for large-scale production of adult stem cells to support development of new cellular therapies

GenCure, a subsidiary of BioBridge Global, today opened the first phase of a new GenCure biomanufacturing facility designed to address a critical roadblock slowing the advancement of cellular therapies and the field of regenerative medicine: A lack of access to large-scale stem cell manufacturing and support services required for cGMP (Current Good Manufacturing Process)-compliant production of biologics for use in human clinical trials and commercial manufacturing.

Biologics development and manufacturing organization supports transfer of laboratory research from preclinical evaluation through clinical trials and commercialization

“The new GenCure BioManufacturing Facility is one of only a handful of independent manufacturing facilities in the U.S. for human bone marrow-derived mesenchymal stromal cells (hMSCs), the most widely used type of stem cell in both research and clinical settings,” said GenCure Chief Operating Officer Becky Cap.

The new GenCure biomanufacturing facility is opening with an initial 1,300 square feet of ISO class 6 clean-room space, with build-out to 10,000 square feet to be completed in 2018. Later phases call for a larger biomanufacturing center to provide additional clean room facilities. GenCure, a not-for-profit, wholly owned subsidiary of BioBridge Global, operates an existing 6,600 square feet of laboratory and clean-room space used for cell and tissue processing. Other BioBridge Global subsidiaries operate an additional 27,000 square feet of laboratory space dedicated to testing and processing operations at the organization’s San Antonio headquarters.

“The new GenCure biomanufacturing facility allows us to launch our flexible biomanufacturing center, with initial efforts focused on hMSCs because of the significant demand for this cell type,” Cap said. “However, the facility also allows for flexible production of other stem cell products and derivatives – hMSCs derived from other sources, such as adipose tissue (fat), birth tissue (placenta and umbilical cord), induced pluripotent stem cells, or extracellular vesicles. We are currently working with potential customers in these areas.”

In addition to providing contract manufacturing services, GenCure also offers development services, based on BioBridge Global’s broad expertise in process and analytical development, high-volume quality control testing, pharma-grade quality management systems and regulatory guidance.

“A point of differentiation for the GenCure BioManufacturing Facility is the scope of the services we can offer to support customers ranging from university researchers to biotech start-ups to established pharmaceutical companies entering the cellular therapy arena,” said Cap.

Mike Fiske, GenCure Vice President of Cell Manufacturing, noted, “The GenCure BioManufacturing Center is unique in that it not only provides a key bridge from discovery research to the evaluation of products in human clinical trials, but it is also capable of providing scale-up and commercial manufacturing expertise.”

GenCure has worked with a number of collaborators to develop economical platforms for large-scale manufacturing of stem cells, while maintaining their critical quality attributes – two requirements for converting laboratory discoveries into cost-effective therapies.

In 2016, BioBridge Global and GenCure led a team including the U.S. Army Institute of Surgical Research and biotech firms Rooster Bio (based in Maryland) and StemBioSys (based in San Antonio), which was awarded a $7.8-million contract from the Medical Technology Enterprise Consortium (MTEC) to develop large-scale manufacturing capabilities for clinical-grade stem cells to be used in research and therapeutic applications.

GenCure and Rooster Bio expanded their collaboration last year, when GenCure was named as the preferred manufacturer of Rooster Bio’s proprietary media components and “off the shelf” human mesenchymal stem cell banks. GenCure has also entered into development and manufacturing agreements with stem cell technology developer StemBioSys Inc.

QualTex Laboratories, GenCure’s sister company, provides in-house quality control services for the release testing of final products.  QualTex, one of the largest independent nonprofit infectious disease testing labs in the United States, is working towards developing and expanding capabilities for cell characterization in this space.

“The result of these collaborative efforts is that we are enabling the development of new cell and tissue-based therapies that advance regenerative medicine and result in tangible benefits for patients,” Cap said. “As we open the new GenCure BioManufacturing Center, we’re celebrating a significant contribution to the BioBridge Global mission of saving and enhancing lives through the healing power of human cells.”

Source:
http://www.gencurebiomanufacturing.org/gencure-opens-biomanufacturing-center/