The United States is a leader in engineering biology research and supporting science and technology fields. However, both local and national markets need further investment to translate the development of these new tools into robust technologies that will support reproducible biomanufacturing.
With its unique business model and advanced research and technologies, San Antonio-based biomedical products manufacturer INCELL is on a mission to propel biomanufacturing in regenerative medicine forward.
Research in regenerative medicine requires specialized expertise, facilities, and sizable amounts of capital. Work on regenerative tissue engineering – using molecular biology as the foundation for replacing, engineering, or regenerating human cells, tissues, or organs to restore or establish normal function— also requires biotechnology manufacturing, a vital part of growing the biotech ecosystem that isn’t discussed as much.
With attention focused on how advanced manufacturing is growing across industry sectors, the Rivard Report visited INCELL’s headquarters off I-10 and DeZavala to learn more about the state of the biomanufacturing industry.
INCELL Excels at the Cellular Level
INCELL is a biomedicine products manufacturer and contract services provider, which manufactures and develops effective treatments for unmet medical needs – conditions for which there exists no satisfactory method of diagnosis, prevention, or treatment.
“We’re at the precipice of total kick ass cell biotechnology,” said INCELL founder, Chief Science Officer, and CEO Dr. Mary Pat Moyer.
A biomedical scientist, entrepreneur, and technology business leader with more than four decades of experience in business and science, Moyer was a professor of surgery but is not a surgeon. In 1981 she became the first female faculty member in the UT Health San Antonio Long School of Medicine’s department of surgery and their first Ph.D. (rather than an M.D.) professor.
Moyer’s path has been a nontraditional one, and it has served her well in the fields of regenerative medicine and infectious diseases. INCELL’s main business units are in cell and tissue therapies as well as vaccines and infectious diseases.
“Things have changed so much, as in the tools and the science, especially the cell biology and genetics,” Moyer said. “I started out as a basic scientist, trained in microbiology and molecular virology. A virologist has to know cells well because viruses are intracellular parasites.”
Moyer brought that cellular knowledge to the medical school’s surgery department, where she was hired to “create research in the department.” Moyer developed her knowledge base in what is now known as regenerative medicine – cell, tissue, and gene technologies, tools, and therapies.
Since Moyer founded INCELL in 1993, the company has developed unique formulas of manufactured sterile media and cell culture products which have been shipped worldwide over the past 10-12 years. This includes two unique INCELL human colon cell lines licensed for research use in cancer, nutrition, environmental, and cell biology studies. INCELL also does contract services for the development, manufacturing, research, and testing of cells, tissues, vaccines, and solutions, thus helping many biotech companies globally.
The media solutions and reagents are part of human tissue bioprocessing used either as direct products or grown as replicating cell cultures which INCELL cryostores in suspended amination. Scientists and doctors use these stored tissues, stem cells, and functional cells to help patients suffering from arthritis, cancer, neural degeneration, cardiovascular diseases, and damaged tissues needing renewal and repair, to name a few applications.
The pathway from concept to patient use requires biomanufacuturing, which INCELL specializes in.
Biomanufacturing Is Essential to Biotechnology
Moyer sees a gap in scientists’ and the public’s knowledge when it comes to commercializing a medical product. It takes more than a good idea and money; an educated workforce, sustained funding streams, quality product manufacturing, and an understanding of the market are also essential.
“When people talk about [taking an idea from] ‘bench to bedside,’ there’s typically no mention of manufacturing,” Moyer explained. “People may think manufacturing is ‘blue collar,’ but it’s critical in order to get anything to the clinic when the patient can use the product.”
INCELL, Moyer stressed, is a small biotech business, rather than a venture capital fueled company. It is difficult and takes longer to go this route, but Moyer has focused on building a strong foundation in a company with well-trained staff, quality contract services, and innovative biotech products for the clinical market.
“You have to work out your basic manufacturing, product release, and safety protocols – scientists typically don’t have training [in] this aspect of commercialization,” Moyer added. “As a business owner I have to invest huge amounts of time and resources to train staff. Young people out of school and university labs may have a good knowledge of conceptual science and general procedures; however, they are inadequately prepared to work in their scientific discipline in industry.”
INCELL was built as a collaborative industry-research-government-education biotech company business model with capital from product sales, competitive contracts, and government small business grants. It adopted a different business model for personalized stem cell medicines with collection and manufacturing kits for specific medical needs. INCELL’s on-site cryostorage facility uses its world-class solutions to store human cells and tissues intended for clinical use.
“We cryostore tumor cells and blood cells from patients at our facility,” Moyer said. “We can grow those cells, and then work as part of a clinical discovery team with medical professionals, scientists, other labs, and patients to help determine if there are personalized therapies – such as targeted drugs or vaccines for cancer or immunotherapies – that could be developed to treat a specific patient’s disease.”
However, Moyer decided a new collaborative team approach with multiple companies would lend itself best to supporting the research, development, and commercialization of so many new and different therapies.
A Family of Companies
In 2016, Moyer set up the Foundation for Cell, Gene and Tissue Innovations (CGTI) as a nonprofit that participates in tissue or cell collections and accepts charitable donations for research, product development, and pre-clinical and clinical testing of manufactured products. Moyer also formed 4RMED to oversee clinical trials and regulatory needs for CGTI, INCELL, and their clients. 4RMED oversees the human subjects research protocols, manages Investigational New Drug Applications (INDs) for drugs and biological products, and prepares documents in support of medical devices and combination products applications.
“Our vision for personalized medicine is that we will have components ready to go on site at INCELL or on location with qualified hospital or clinical partners,” Moyer explained. “For a patient presenting with a targeted disease, INCELL or its collaborating clinical sites, could offer off-the-shelf processes, products, or participation in ongoing clinical studies for a faster response time.”
With projects and products in the queue that address unmet medical needs and many targeted diseases, the cell therapy products will be commercialized by new “spin-off companies” funded through private and public investors and supported through INCELL’s affiliated incubator company TEKSA Innovations Corp.
In June 2016, INCELL announced its new partnership with a Belgian investor group formed by Wisetree Invest and 4 for Cells, expected to fuel 50 new jobs at INCELL’s headquarters in San Antonio over the short term. The resulting joint venture company Bioturnkey will have a U.S. location in San Antonio and a site in Belgium.
Moyer opted for a collaborative partnership with INCELL and Bioturnkey working in both the U.S. and Europe. The parallel development of biotech products with coordinated manufacturing and commercialization in both markets would reduce delays, costs, and complications for new products entering the clinical markets in both places. By working in tandem, the partners can ensure products meet regulatory requirements so products are ready in about the same time frame in both markets.
The Bioturnkey business plan is to accelerate developing personalized medicine and cell therapy products by linking INCELL’s quality manufacturing technologies with closed bio-isolators and “ready-to-go” systems in Europe and the U.S. Moyer described this collaborative approach as a startup accelerator because the newly created companies can take advantage of manufacturing expertise and techniques already in place at INCELL and, therefore, get products to market faster.
According to Moyer, it’s an exciting time to be working at the forefront of regenerative medicine. “It is my passion and my life’s work to see these products get to the clinic,” she stressed.
The leveraged, collaborative support via CGTI, INCELL manufacturing and testing, 4RMED clinical trials, TEKSA incubation of new companies, and collaborative business initiatives with Bioturnkey and other entities in the U.S. and globally, should help catapult San Antonio’s growing regenerative medicine industry forward.