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.
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 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.
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…
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…
The rapid increase of emerging cell and gene therapies is putting stress on the infrastructure that supports the collection and processing of cellular starting material. Industry standardization can help ease this strain. While there are many opportunities for standardization in cell collection and processing, one that could have an immediate impact is a quality system…