Stem cell therapy sterility assurance is becoming more important in the pharmaceutical industry. The genetic manipulations of the cells involved create a powerful tool to treat serious diseases, such as cancer. In 2017, the Food and Drug Administration (FDA) made several advancements towards the regulation of stem cell therapy:
- Published perspective on stem cell therapy in the New England Journal of Medicine
- Increased regulation enforcement for stem cell clinics
- Released new guidance, Regulatory Consideration for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
To regulate this industry, the FDA uses a risk-based enforcement approach with considerations for how and why the products are used. FDA’s discretion for how regulations will be enforced ends November 2020. Companies responsible for ensuring full compliance should contact the FDA before the cutoff to remove uncertainty regarding the regulatory status of their products and to determine whether the products are subject to premarket approval. FDA guidances are intended to help bring innovative, safe, and effective products to patients as efficiently as possible.
Bacterial Infections after Stem Cell Product Usage
In early 2019, the Centers for Disease Control and Prevention (CDC) reported bacterial infections after use of stem cell products and are currently investigating the ReGen Series. The FDA inspection of the ReGen product manufacturer found problems with its process, including that the facility had not screened the umbilical cord blood donors for diseases such as HIV, hepatitis B, and hepatitis C. Patients reported symptoms of pain, swelling, and chills within a few days of receiving the stem cell product, which was later recalled.
The European Medicines Agency (EMA) released their point of view on stem cell medicinal products in 2011. This documentation is used in conjunction with previously published guidance, EMEA/CHMP/410869/2006, which addresses general aspects of cell-based medicinal products. For genetic modification of stem cells, consult the draft guideline EMA/CHMP/GTWP/671639/2008.
This paper also covers:
- Current EMA Standards for ATMPs
- Risk Assessment
- Manufacturing Clean Area Systems
- Storage System
- Aseptic Process Simulation
- Quality Control
- Viable and Total Particle Monitoring
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