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.
Cord blood’s unique, naïve biology often comes up as a reason to use it as an allogeneic cell therapy source material. But as Cleveland Cord Blood Center Executive Director Marcie Finney explains, there are 4 non-biological factors cell and gene therapy developers should also consider.
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.
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.
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…
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…
Sourcing your starting material from high-quality, healthy donors matters when you are manufacturing an allogeneic cell therapy. Any misstep can mean delays in your allogeneic therapy’s development. That makes your choice of a cell sourcing vendor critically important. Our team has sourced and collected cells for time critical cell therapies from more than 100,000 volunteer…
Travel disruptions caused by COVID-19 have meant little more than delayed holidays or missed work meetings for most of us. They’re inconveniences, but hardly life-threatening challenges. But for patients who depend on cell therapies to provide potentially curative treatments, the pandemic’s canceled flights and closed borders have posed a real threat to their wellbeing. In…
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…