Do race, ethnicity and ancestry still impact HLA genotyping?
Race, ethnicity and ancestry. How are they different? And, as testing and cell therapy science evolves, do they still impact HLA genotyping? That was the focus of discussion
Don’t overlook histocompatibility in allogeneic cell therapy
Many allogeneic cell therapy developers believe they can overcome HLA barriers. However, HLA is only one factor to consider, and the issue of histocompatibility should not be overlooked.
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.
HLA, histocompatibility and the science of cell source selection
Allogeneic cell therapy development has been top-of-mind in recent years as autologous cell therapies see continued success. For more than three decades, the largest group of HLA experts in the world has worked to create a unique cell source selection expertise. That expertise holds value for allogeneic cell and gene therapy developers, too.
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.
6 considerations when evaluating cell sourcing vendors
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…
How COVID-19 is changing the production of cell therapies
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…
Managing donor collections during the COVID-19 pandemic
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…
The role of ‘super donors’ in cell therapy scalability
Updated July 29, 2021 Allogeneic cell therapy developers face a challenge as the cell and gene therapy industry grows. How can they meet the future demand for allogeneic donors that allows them to scale their capabilities to reach larger numbers of patients while maintaining consistency? Some companies suggest the use of a dedicated donor pool…