Cell and gene therapy developers are pursuing allogeneic approaches, which ideally could be produced in greater quantities and be available “off-the-shelf.” Those using natural killer (NK) cells and cells derived from induced pluripotent stem cells (iPSCs) are creating buzz in the industry. Drs. Sarah Cooley, Stephen Gottschalk and Stephan Grupp offer their insights.
The COVID-19 pandemic impacted nearly every aspect of the cell and gene therapy supply chain. That required companies throughout the cell and gene therapy industry to pivot quickly to continue to deliver for patients. Be The Match BioTherapies® was no exception.
As a cell and gene therapy developer, your cell collection protocol requirements and specifications will impact your apheresis center network selection strategy and your ability to efficiently scale your processes. Any time your protocols or processes differ from those in place at a center, there are likely implications for training, forms and standard operating procedures (SOPs), which can delay your first collection.
As your cell or gene therapy moves toward commercialization, supply chain readiness is critical. But what does it take to develop a successful supply chain strategy to support a commercial launch? Orchard Therapeutics and Be The Match BioTherapies® have first-hand experience.
After raising a record $19.9 billion in funding in 2020, doubling the previous year, the cell and gene therapy industry shows no signs of slowing down. Forecasters predict more record growth this year, especially in terms of regulatory decisions; at least nine new products have been approved or are up for approval in the United…
Allogeneic cell therapies are inherently complex. But they also hold the potential to scale to treat large segments of the population. Martin Maiers, MS, is the Vice President of Innovation at the National Marrow Donor Program® (NMDP)/Be The Match®. He and his team develop software and analytical methods used to predict factors that can impact…
On the last day of February, millions of people came together globally to honor Rare Disease Day. It’s a day dedicated to raising awareness of rare diseases, the impact they have on people’s lives and the importance of developing treatments to improve quality of life for patients and families around the world. The National Institutes…
For many in the field of cell and gene therapy, 2020 had a singular theme: COVID-19. Dozens of clinical and preclinical trials were launched in labs around the world to test the efficacy of cell therapies to target complications from COVID-19 infection. But while the pandemic drew most of the media attention, it wasn’t the…
There is no question the COVID-19 pandemic has disrupted cell therapy logistics like never before. Supply chain challenges are no longer the exception, but the norm. So how can companies overcome autologous cell therapy logistics challenges to deliver time-sensitive source material and manufactured therapies on time? It’s not easy in our current environment, but it…