Watch Insights on the ISPE Guide: ATMPs – Allogeneic Cell Therapy with Guide Co-Lead Erik Steffensen
Key Takeaways from Steffensen’s Video
Allogeneic cell therapies hold immense potential for the future. We can now see very interesting clinical data for each treatment of eye diseases with allogeneic cell therapies, type 1 diabetes, and also Parkinson’s disease, so this is a very interesting area to follow.
Additional Insights from Steffensen
Steffensen: For allogeneic cell therapies, the process begins with healthy donor cells that are expanded—essentially multiplied—and may be differentiated into the desired type of cell. After recovery, purification is limited because harsh steps could damage the cells. This contrasts with conventional biologics, which rely on chromatographic purification steps; such steps are not feasiblefor allogeneic cell therapies.
It is important to ensure that raw materials are of high quality because impurities and other substances present in them often end up in the final product. Additionally, everything the product comes in contact with during manufacturing must meet strict standards.
This allogeneic Guide provides comprehensive direction on designing the manufacturing process, including detailed process steps, equipment recommendations for various scales, also guidance regarding facility designs, and GMP requirements. What makes this Guide very unique is its focus on emerging technologies, offering insights from industry experts and state-of-the-art knowledge to support you as you progress in this field. The hope is that you enjoy the Guide and find it helpful.
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