Ask the Expert – GMP Proteins for Cell Therapy Manufacturing

By on May 8, 2017
Ask the Expert

GMP (Good Manufacturing Practice) growth factors and cytokines designed for therapeutic manufacturing are a critical component in defined medias. To date, the cell therapy industry has accepted the term GMP for this reagent class despite the fact that there is no direct oversight by regulatory authorities. These proteins are intended to be used during further manufacturing and do not come in direct contact with the patient. In fact, cell therapy manufacturers need to take steps to ensure that reagents used for further manufacturing are removed before the cells can be used in the clinic. In addition, FDA-regulated, clinical grade proteins that can be directly used as therapeutics may also be described as GMP, leading to confusion of the term “GMP” within different contexts.

We recently published a blog, “GMP Proteins for Cell Therapy Manufacturing: Top 6 Things to Know,” that discusses what you should look for in a supplier. It was a popular piece with readers, so we asked the author, Tim Manning, if he would host an Ask the Expert session on the topic. Tim was kind enough to agree to answer questions from readers this week on the topic of GMP protein manufacturing.

This should be of interest to anyone interested in cell therapy research or those manufacturing cells that will be used as therapeutics.

This Ask the Expert session is sponsored by R&D Systems and is hosted by Tim Manning, Product Manager for Proteins at R&D Systems, a Bio-Techne brand. He has an extensive knowledge of protein production and manufacturing, quality control, and GMP guidelines. Before joining Bio-Techne, Tim received his PhD in from the University of Alabama at Birmingham and was a Postdoctoral Fellow at the University of California, San Diego.

Please take advantage of the opportunity to ask our expert a question and participate in a lively discussion on GMP proteins for cell therapy manufacturing.

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