In addition to commercial cell therapy CDMOs, there are other industry players that support the cell therapy industry, including academic and medical CDMOs. While these groups do contribute to the cell therapy CDMO market, their manufacturing capabilities are limited in scale and best suited to small, early-stage clinical trials.
For example, Cellular Therapeutics was awarded a contract from the UK Cell and Gene Therapy Catapult to produce a new cell-based cancer therapy in August 2015. Cellular Therapeutics is manufacturing the engineered cells for the Cell and Gene Therapy Catapult over a 2 or 3 year period, providing enough clinical material for ongoing Phase I and II trials, which are due to complete recruitment in 2017. However, preliminary manufacture was carried out at the UCL Institute of Child Health/Great Ormond Street Hospital cell therapy production unit.
This allowed the first patient to be enrolled into the trial in December 2014, but additional capacity was needed to accelerate the project. It is not uncommon for academic institutions to provide very small-scale, early-stage cell therapy CDMO services, but typically, they cannot provide the throughput or economies of scale provided by dedicated commercial and non-profit organizations.
Academic institutions involved in cell therapy manufacturing include:
- Stanford’s Lab for Cell, Gene Medicine in Palo Alto
- Waisman Biomanufacturing, a facility in the Waisman Center at UW–Madison
- Center for Advanced Cellular Therapeutics, Penn Medicine campus
- The Massachusetts Accelerator for BioManufacturing – Recently expanded its facilities
- Upstate Stem Cell cGMP Facility at the University of Rochester Medical Center
- University of Miami’s Interdisciplinary Stem Cell Institute, Clinical Research Cell Manufacturing Program (ISCI-CRCMP)
- TUMCells a joint initiative of Faculty of Medicine Technical University Munich (TUM)
A medical clinic with cell therapy manufacturing expertise is:
- Mayo Clinic Built a Manufacturing Facility for Cardio3 Trials (Cardio3 is now Celyad)
To view commercial CDMOs, see “Cell Therapy CDMOs – Role of Contract Manufacturing for Cell Therapies.”