GenCure (San Antonio, Texas, USA) today opened the first phase of a new biomanufacturing center 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.
“The new GenCure BioManufacturing Center 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.
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.
“The 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.”
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, according to 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, a subsidiary of BioBridge Global, is a not-for-profit organization focused on enabling the development of cell- and tissue-based therapies and companies by providing access to source materials, cGMP manufacturing experience and clinical trials support.