FDA Guidances for Biological and Cell Therapy Products Seek To Bring Clarity to Drug Manufacturing

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This week, Business Insider called the the stem cell industry in the USA the “Wild West”, referring to the flurry of stem cell clinics (over 170 of them) currently operating throughout the USA, most of which with little or no government oversight.

These clinics have fluorished for a while, and while the FDA has not taken any formal action, it has began addressing loopholes that have allowed them to operating, one of which is a draft guidance released in December 2014 addressing the fact that the stromal vascular fraction, isolated from adipose tissue and containing adipose-derived stem cells, which is then used as a cell therapy product, is generally considered “more than minimally manipulated”, essentially sending the message that these clinics might have to go through formal FDA approval processes in the future.

Mushrooming stem cell clinics were not the only ones targeted by recent FDA guidances.

Last month, the FDA Issued a guidance, “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Product to a Reference Product,” wherein the agency calls for developers to provide clear clinical demonstration that a certain product is similar to a claimed reference product. This includes same biological and physical performance, including concentration and volume if the product is injectable.

And as recently as last week, the FDA issues a guidance, “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Draft Guidance for Industry,” which outlines conditions under which the FDA will not take action against outsourcing facilities engaged in mixing, diluting, or repackaging of biological products. It also highlighted that none of these activities are allowed for any cell therapy product outside of its BLA.

Finally, just this week the FDA issues a new guidance, titled “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products,” which focuses on changes made to chemistry, manufacturing and controls of biological products. Essentially, it seeks to clarify what “established conditions” are and when a manufacturer must report changes made to the production of a product. You canr ead the guidance here.

By the issuance of these guidances, the FDA is seeking to bring more clarity to the manufacturing of biological, chemical and cell therapy products, and it’s refreshing to see the agency responding to industry calls for such guidances. While they are not perfect (critics have reported many drawbacks to some of the recent guidances), they are a first step.


Akron Participates at Standardization Workshops

Akron’s efforts at contributing to the cell therapy field by being involved in standardization efforts have been one our top priorities. As a committee member of the Alliance of Regenerative Medicine, we are closely involved with regulatory efforts aimed at legislative changes for better industry standards.

This week and next week, Akron will participate at two related events focusing on advancing efforts at supporting standardization in the cell therapy field.

You can meet Akron at:

Click the links above for more information.

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