International regulations for allogeneic cell source material

When you procure cellular starting material or distribute a cell or gene therapy product across international borders, you must consider the country or regional regulatory requirements at play and where they diverge. Allogeneic cell therapy sponsors face common challenges when treating a global patient population with therapies using healthy adult donor starting material.

Effect of rapid cell therapy growth on collection capacity

The rapid growth of the cell and gene therapy industry is a positive for patients. However, it comes with increasing demand for high-quality cellular source material collected at apheresis centers. Managing collection capacity impacts from this growth requires understanding challenges from the perspective of the apheresis center and collaboration across the industry to develop solutions.

The promise allogeneic NK cell and iPSC therapies hold

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.

Creating scalable cell therapy collection processes

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.

Martin Maiers is the Vice President of Innovation at the NMDP/Be The Match

HLA’s future impact on allogeneic cell therapy development

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…

Erin Rasch, Vice President of Sales and Business Development for Be The Match BioTherapies

Maintaining business continuity during COVID-19

Just like for all businesses, March 2020 began what would become months of uncharted territory for our Be The Match BioTherapies® team. Overnight, travel to visit with cell therapy partners and potential clients was grounded. Conferences where connections are made…canceled. Even team meetings that were once in person moved online. But through these challenges, resiliency…