Clinical Stem Cell Manufacturing

Introduction

There are an increasing number of promising new stem Cell Therapy candidates in development and many are showing promising results in clinical studies. As more stem cell therapies move from the lab to the clinical setting, there is increased interest in identifying best practices for stem cell manufacturing. Many researchers have specific questions about scaling up stem cell production, optimizing culture media, selecting the right manufacturing equipment, and the regulatory requirements for clinical production. If you have questions regarding stem cell manufacturing, then please join us for a special Ask the Expert session “Clinical Stem Cell Manufacturing.”

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Question 1

Hello, I am Brazilian and pharmacist, and I would like to know in which areas and or services with stem cells, a pharmacist is able to act, and what specializations are suggested to my occupation for that purpose (stem cells).

The role of the pharmacist in the administration of stem cell therapies has yet to evolve, in my opinion. Currently, pharmacists are being utilized in stem cell clinical trials in two ways; 1) to dispense cellular therapies (from a bag to syringes, for example) to maintain the blinding of the physician administering the therapy and … Continued

Question 2

What do you think is the biggest hurdle faced when moving stem cells from lab to clinical manufacturing?

The biggest hurdle in my mind is changing the mindset from research to developing a definition of the product/therapy. There are many technical issues such as scale up, closed system development, serum free media, quality control, etc but none of these can be successfully addressed until you understand the critical aspects of the therapy you … Continued

Question 3

Can you explain the difference between autologous and allogeneic stem cell therapies in terms of how they are manufactured clinically.

All stem cell therapies should be manufactured under Good Manufacturing Practices (GMPs). The primary difference between allogeneic and autologous are the source of the cells for the therapy. Allogeneic therapies are manufactured in large batches from unrelated donor tissues (such as bone marrow) whereas autologous therapies are manufactured as a single lot from the patient … Continued

Question 4

What do you think is the importance of having serum free and/or animal free media in clinical stem cell manufacturing?

Animal-free, chemically defined media would be the ideal choice for all stem cell manufacturing from the standpoint of consistency and control of materials. However, not all cells can be expanded and/or differentiated without serum or other animal derived materials. The use of animal derived materials is acceptable with the appropriate sourcing of materials and testing … Continued