As your cell or gene therapy operations scale from early-phase clinical trials to larger populations in late-stage trials and commercialization, your supply chain complexity — and risk — increases. Anticipating common setbacks and actively planning for their solution requires a specialized and collaborative approach with your supply chain partner. Keep these key considerations top of…
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…
As the world responds to the COVID-19 pandemic, a growing number of biotech companies are pursuing clinical trials to determine the efficacy of using cell therapies to halt the virus’s deadly march. One such example is the use of mesenchymal stem cells (MSCs), multipotent stem cells found in a variety of tissues such as bone…
This piece written by Joy Aho, PhD, Senior Product Manager, Be The Match BioTherapies®, was originally published on CellandGene.com in April 2020. We’re living through unprecedented times, both as individuals and as a nascent cell therapy field. The COVID-19 pandemic has had negative implications for manufacturing and shipping across nearly all industries, including very pronounced…
Even before COVID-19 reached pandemic levels, teams at the National Marrow Donor Program® (NMDP)/Be The Match® had their eye on an important part of the cell therapy supply chain—donor collections. Collections from allogeneic donors are critical to getting time-sensitive life-saving cell therapies to patients around the world. But donors often must fly to the apheresis…
Updated March 27, 2020 (original story follows) Editor’s note: It’s been just over one month since we first shared how established relationships have helped our organization navigate the impacts of the coronavirus on the cell therapy supply chain. Since then, much has changed. Just a few days after we posted the story, reports from Italy…
The emergence of novel cell therapy technologies has led to questions about the necessity of human leukocyte antigen matching (HLA matching) in the development of potential “universal” allogeneic cell therapies. After all, if you can eliminate alloreactive responses, what role would HLA matching play? Martin Maiers, MS, is the Vice President of Biomedical Informatics for…
Looking back at the headlines in advancements in cell and gene therapy in 2019, one theme that comes to mind is collaboration. New partnerships have encouraged progress in the field. One example is the recently announced alliance between Harvard and MIT to develop a Center for Advanced Biological Innovation and Manufacturing. And cooperation between stakeholder…
One patient, one product. The successful on-time delivery of cell and gene therapies isn’t just good business—it’s a matter of survival for patients. When there’s no room for mistakes, an advanced approach is needed to overcome supply chain disruptions that create barriers to successful on-time delivery. Severe weather, customs complexities and flight delays are three…