Cell therapies are regulated as biologics under the Center for Biologics Evaluation and Research division of the FDA. All somatic cell therapies are regulated as biologics, however, some of the human cell therapy products are not considered biologics because of the safety concerns of infectious disease transmission.1

Since cell therapy products are very unique and have challenges as it pertains to the use and the effects on the body, the FDA uses existing regulations for drugs and biologics to regulate cell therapy. This means that 21CFR 1271 for tissues, 21CFR600 and 610 for biologics, the investigational new drug requirements from 21CFR 312, and drug manufacturing requirements from 21CFR 211 and 212 are all applicable.

Testing requirements for cell therapy products are the same as cell banks. Since in-process testing requirements are not defined by the regulations the FDA recommends the methods outlined in 21CFR610. Because of the uniqueness of cell therapy products, FDA does provide manufacturers the option to propose test methods that are tailored for their products, however, the manufacturer will be required to provide evidence of equivalence of these tests to 21CFR610.

Some of the tests required are potency, sterility, purity, and identity. Some of these tests may take longer to get the results and the cells may die in the meantime. In such cases, FDA states that it tries to be flexible with the final product testing and considers all other options too.

Cell and gene therapy research and development are growing at a faster rate in the US. Establishing appropriate manufacturing controls remains a hurdle because of the ability to reproduce consistent products, variability in the bioassays, etc. Amidst the pandemic, plasma transfusion being considered a potential therapy against COVID-19 is evidence that cellular therapy has the potential to be a solution for the unmet needs of the healthcare industry.

EMMA International is here to assist with all of your quality and regulatory needs for your cell therapy products. Give us a call today at 248-987-4497 or email us at info@emmainternational.com.


1FDA (March 2021) Cellular & Gene Therapy Products retrieved on 03/27/2021 from https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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