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.

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…

Representation of cell therapy production disruption due to COVID-19 pandemic

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 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…

Representation of NMDP/Be The Match donor collection network

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…