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4 Pharmaceutical Technology ® Trends in Manufacturing eBook May 2024 PharmTech.com Michaela Doláková, chief microbiologist Veronika Horková, microbiologist Klára Sochorová, senior quality compliance manager Daniela Rožková, chief technology officer, at SCTbio. Rapid Sterility Methods for CAR T-cell Therapies C ell and gene therapies are rapidly emerging as promising alternatives to treat patients with severe forms of cancer, particularly hematological malignancies, due to their targeted efficacy and high potency. These types of therapies are often referred to as advanced therapeu- tic medicinal products (ATMPs) and are gaining trac- tion in the public arena as a result of FDA's approval of chimeric antigen receptor (CAR) T-cell therapies. Six different CAR T-cell therapies are now approved by FDA for the treatment of certain types of lympho- mas, some forms of leukemia (1), and most recently, multiple myeloma (2). CAR T-cell therapies involve genetically engineer- ing a patient's own or a donors' T-cells to target and destroy cancer cells. They are highly complex and potentially risky treatments that are showing clin- ical and commercial success where other available treatments have failed. Due to the specialized nature of CAR T-cell ther- apy and the vulnerability of patients with compro- m ised im mune systems, ster i lit y is essent ia l for these treatments. As CAR T-cell products are made up of living cells, it is not possible to perform ster- ilization (e.g., sterile filtration) of the final product. Therefore, safe and effective CAR T-cell therapies rely on rigorous sterilit y testing to ensure patient safety and product quality. Sterility testing of autologous cell therapies In autologous cel l t herapies, such as CAR T-cel ls, sterilit y testing is an essential and critical step in the batch release process under the Code of Federal Regulations, Title 21, par ts 210 and 211 for current ALPHA TAURI 3D - STOCK.ADOBE.COM A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.