As the cell therapy industry grows, so does the realization that biomanufacturing processes are critical to it’s clinical and commercial success. The challenge lies in that each individual cellular therapeutic has unique process requirements. So, there is no typical, one-size-fits-all manufacturing solution. Fortunately, industry players are working to develop biomanufacturing improvements and efficient workflows that can be broadly applied.
It is exactly these biomanufacturing improvements that are the focus of new manufacturing organizations developed through industry-academic (or government) partnerships. Specifically, their goal is to develop improved, cost-effective manufacturing solutions that will facilitate clinical and commercial success of cell-based therapies. Here are three recently announced efforts:
- Georgia Research Alliance, Georgia Tech and Atlanta-based Marcus Foundation together launched the $23 million Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M) at Georgia Institute of Technology. The goal of this research center is to develop processes that will ensure consistent manufacturing of high quality cell-based therapeutics at a low-cost. This is the first center of its kind in the US and will manufacture cellular therapeutics in collaboration with research and clinical institutions around the world.
- Catapult, the UK-based organization focused on building the Cell and Gene Therapy industry in the UK recently began construction on their new £55 million manufacturing center. Upon completion in 2017, this is expected to be the world’s first facility of its kind. It’s goal is to provide an infrastructure to manufacture cell therapeutics for late phase clinical trials and commercial supply. The facility will operate is like a ‘manufacturing hotel’. Clients will work with experienced personnel and core equipment, avoiding committing capital to a permanent commercial facility before knowing whether a product is going to be successful in the clinic.
- GE Healthcare recently teamed up with the Canadian Government and Center for Commercialization of Regenerative Medicine (CCRM) to establish the $28 million Centre for Advanced Therapeutic Cell Technologies (CATCT) in Toronto, Ontario. The goal of this new center is to accelerate the development and production of approved and commercially available cellular therapeutics for patients. This goal will be strategically accomplished by introducing new technologies to solve manufacturing challenges and providing cell therapy companies with facilities, equipment and expertise. Thereby, establishing and optimizing manufacturing workflows to produce large cell numbers required for clinical and commercial use. While GE and CCRM are spearheading this initiative, they have already built a strong industry consortium of nearly 50 collaborators ranging from large multinationals to emerging biotechnology companies to help implement their vision. Key companies include GE Healthcare, Lonza, Sartorius Stedim, Pall, and others.
These public-private manufacturing centers will begin to address the conundrum that can single-handedly inhibit success in the cell therapy industry. Beyond the basic need for increased manufacturing capacity, improved solutions for scale-up and commercialization of gene and cellular therapeutics in a reliable, efficient, and cost-effective manner is critical to sustain the growth of the industry. And we applaud the industry for joining forces to develop biomanufacturing improvements for these foundational issues that hold all stakeholders back.
To learn more about key manufacturing transitions, decisions and shifts in the cell and gene therapy industry, see our recent Market Brief. For more on biomanufacturing improvements, including new manufacturing systems and solutions, see our Market Report (coming March) and an earlier blog where we discuss new approaches to specifically address small-scale manufacturing.
Guest Blogger: Brittni Peterson is a currently in the PhD program in neuroscience at the University of Minnesota and an exceptional intern for Nelsen Biomedical.