Meeting the Urgent Demands of ATMPs with Rapid Microbial Testing
Advanced Therapy Medicinal Products (ATMPs)—including gene therapies, somatic cell therapies, and tissue-engineered products—are the future of medicine. But producing and delivering these therapies presents unique challenges. Unlike traditional pharmaceuticals, ATMPs often have short shelf lives and require quick administration to remain effective. This article explores when rapid microbiological methods (RMMs) are the right choice over traditional compendial methods.
Understanding Quality Control (QC) Challenges for ATMPs
Short Shelf Life
ATMPs, like CAR-T cell therapies, are produced in small, patient-specific batches. Due to limited stability, they often need immediate administration to retain potency. Traditional microbiological tests, especially those for sterility, are culture-based and can take days or even weeks. For short-lived ATMPs, this delay is impractical—by the time results are available, the therapy may no longer be viable.
Small Production Volumes
Unlike mass-produced drugs, ATMPs are created in small, personalized batches. QC methods that require large sample volumes risk reducing the amount available for patient treatment, forcing a choice between testing a precious sample or saving it for the patient.
Contamination Risks
Many patients receiving ATMPs are immunocompromised or in critical condition, making them more susceptible to infections. This heightens the need for rapid, highly sensitive QC methods to ensure contaminant-free ATMPs.
Microsart®️ ATMP Sterile Release allows QC results within 3 hours.
When to Consider Rapid Microbiological Methods
The pharmaceutical industry has long relied on compendial methods—mainly culture-based tests—outlined in pharmacopeial guidelines like the U.S. Pharmacopeia (USP) or European Pharmacopeia (EP). These are well-validated and widely accepted for conventional products, but they fall short for ATMPs in terms of speed and practicality.
RMMs solve this problem. They allow timely and safe release of ATMPs without compromising efficacy. These methods provide results in hours rather than days, use only small sample volumes, and support agile production workflows that catch issues before the final product is ready for administration.
Regulatory Support for Rapid Methods
The regulatory landscape for ATMPs is evolving, and agencies like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are increasingly supportive of RMMs.
The EMA has specific frameworks for ATMPs that emphasize rapid, accurate QC, encouraging alternative methods to boost patient safety and efficacy. Similarly, the FDA’s Center for Biologics Evaluation and Research (CBER) supports RMM adoption, reflecting a commitment to balancing strict QC with the need for prompt product release.
The Solution for Fast Release Testing
Sartorius offers a range of rapid microbial testing products designed specifically for ATMPs, such as the Microsart® ATMP Sterile Release Kit. With this kit, labs can detect bacterial and fungal contamination within three hours, and is a lot shorter than traditional sterility testing times.
Explore the resources below to discover why QC labs trust Microsart® kits for fast and reliable product release testing. You can also try them for free—request it here.
- Quantitative and Digital Polymerase Chain Reaction (qPCR/dPCR): Unlike traditional methods, PCR methods identify microbial DNA directly, avoiding false negatives that may come up in culture-based tests. While dPCR is a newer technique, qPCR is widely used for ATMP QC. It is highly sensitive and detects microbial DNA in just hours.
- ATP Bioluminescence: This technique measures ATP to indicate microbial contamination, providing a rapid total microbial load assessment. Although it lacks the specificity of DNA-based methods, it’s ideal for environmental monitoring and in-process testing.
- Fluorescence-Based Detection: Using fluorescent dyes that bind to microbial cells, these methods deliver fast, real-time monitoring, making them effective in detecting viable microorganisms.
