ATMP Sterility Testing

ATMP Sterility Testing

Stem cell therapy is a groundbreaking field in the pharmaceutical industry, offering powerful tools for treating severe diseases such as cancer. The genetic manipulations involved in this process, however, necessitate stringent regulations to ensure sterility and safety. In 2017, the Food and Drug Administration (FDA) took significant steps toward regulating stem cell therapy, marking a pivotal moment in the industry. This blog provides a background in ATMP sterility testing and the FDA in relation to the paper linked below that outlines guidelines on good manufacturing practices specific to Advanced Therapy Medicinal Products.

ATMP Sterility Testing FDA Initiatives
Stem Cell Therapy Sterility Assurance

The FDA, recognizing the critical importance of ATMP sterility testing, implemented several key advancements in 2017:

  1. Published Perspective in the New England Journal of Medicine: The FDA showcased its commitment to transparency by publishing a perspective on stem cell therapy in a reputable medical journal, providing insights into the regulatory considerations and challenges associated with this innovative treatment.
  2. Increased Regulation Enforcement: In response to the growing importance of stem cell therapy, the FDA intensified its enforcement efforts, particularly focusing on stem cell clinics. This move aimed to ensure compliance with established regulations and standards within the industry.
  3. Released New Guidance: Regulatory Consideration for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Minimal Manipulation and Homologous Use:

    The FDA released a comprehensive document, clarifying the considerations for human cells, tissues, and cellular products. This guidance emphasized the importance of minimal manipulation and homologous use in the context of stem cell therapy.

Risk-Based Enforcement Approach to ATMP Sterility Testing

To effectively regulate the stem cell therapy industry, the FDA employs a risk-based enforcement approach, taking into account how and why products are used. It is crucial for companies involved in ATMP Sterility Testing to proactively engage with the FDA. The agency’s discretion in enforcing regulations concluded in November 2020, urging responsible companies to seek clarity on the regulatory status of their products and determine whether premarket approval is necessary.

Bacterial Infections and Regulatory Response

In early 2019, concerns arose when the Centers for Disease Control and Prevention (CDC) reported bacterial infections linked to the use of stem cell products. The FDA conducted an inspection of the ReGen product manufacturer, revealing issues with the screening process for umbilical cord blood donors. The facility had neglected to screen for diseases such as HIV, hepatitis B, and hepatitis C. Patients experienced adverse symptoms, leading to the recall of the stem cell product.

The paper linked below provides guidelines on good manufacturing practices specific to Advanced Therapy Medicinal Products (ATMP).

Want to learn more?

Download the full paper here


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