Preparing for a cell culturing industry

Anticipating new drug approvals that could show up as soon as 2017, the bioprocessing industry is gradually assembling the pieces that will, in fact, constitute a new form of pharmaceutical manufacturing: cell culturing, a.k.a. regenerative medicine, a.k.a. stem cell processing. Last week, GE Healthcare’s Life Sciences unit announced the acquisition of BioSafe S.A, a Swiss company with over 15 years’ experience in cell culture, primarily in cord blood processing to extract stem cells. A GE Healthcare statement noted that BioSafe has “proprietary products [that] offer significant advantages over conventional processing tools, with closed fluid pathways, built-in traceability and single-use consumables.” Olivier Waridel, Biosafe CEO, will continue to lead Biosafe within the new integrated GEHC structure.

Phil Vanek, GEHC GM of cellular technologies, explains the significance of the acquisition. “Conventional biotechnology uses living cells that are usually grown in batches, then lysed (broken open), with target proteins such as monoclonal antibodies that filtered and recovered. In cellular technology, the cells themselves are the product, and in the case of autologous (derived from the patient) cells, the need to prevent cross-contamination is paramount.” So, for example, BioSafe’s familiarity with single-use manufacturing components (such as bags or other containers that hold cells) is a key capability.

There have been cellular technologies in use in the past and currently—bone marrow transplants, for example, are a type of cellular therapy. Nevertheless, the supply chain aspects of what is being proposed are daunting. “Look at it this way,” says Vanek. “Autologous cellular therapies are expected to produce a patient-specific therapy that will cost several hundred thousand dollars. Are you going to ask the healthcare system to collect patient cells, process them, and then drop them in an express delivery box and put it on a truck?” Vanek expects that, at a minimum, most cellular therapy delivery will involve cryopreservation technologies, such that patient samples and treated cells will be shipped in frozen state, and have shelf lives that will enable successful storage and, ultimately, administration to the patient.

GEHC Life Sciences has made a number of key moves in this year to move the technology forward: in March, it joined with Mayo Clinic to form Vitruvian Networks, Inc., a provider of IT services in connection with cellular therapies, and in January, it announced the the BridGE@CCRM Cell Therapy Centre of Excellence, a US$31.5 million co-investment with the Canadian Government to promote new technologies for the production of cellular therapies in Toronto.

Meanwhile, the Georgia Research Alliance and several Georgia universities have formalized the National Cell Manufacturing Consortium (NCMC) and, in June, issued a 10-year roadmap for guiding US development in this area. “Most US investment in this field to date has neglected the advancement of cell manufacturing,” according to the report. “Federal agencies … invested nearly $3 billion in regenerative medicine from 2012–2014, most of which was focused on basic and clinical research of new therapies. Bringing these new life-changing cell-based medical products to market critically depends on the large-scale, cost-effective, reproducible manufacturing of a variety of cell types.”

The roadmap highlights key technological developments that will be needed in:

• cell processing
• cell preservation, distribution and handling
• process monitoring and quality control

along with better regulatory and workforce training efforts. The Georgia-based effort, with federal support, mirrors similar efforts going on in Canada, the UK, Germany, Australia and elsewhere; a global scramble for technological and business leadership is shaping up.

“You can liken this industry today to building an airplane while it’s flying,” concludes GE’s Vanek. “Researchers have been grabbing whatever technologies are available to address commercialization; we really don’t know what the future shape of the industry is going to be, but our company’s goal is to be flexible."