Cell and gene therapy manufacturing is characterized by complex processes and high costs, with each batch often being specific to an individual patient. The loss of even a single batch due to contamination or other issues can be devastating, both financially and for patient care. This highlights the critical need for reliable and rapid microbiological monitoring methods, such as Biofluorescent Particle Counters (BFPC), to efficiently measure sterility and reduce risk.

BAMS (BioAerosol Monitoring System), a BFPC manufactured by MicronView, offers a solution by providing real-time, accurate, and sensitive detection of microbial contaminants. Unlike traditional methods that can take days for results, BAMS delivers actionable insights in real-time, allowing for immediate intervention to prevent total batch loss. BAMS can be successfully used to evaluate airborne microbial and overall particulate levels at critical points in the production process. This capability is invaluable in maintaining the sterility and integrity of cell and gene therapies, ensuring that each batch meets the highest standards of quality and safety.

At the heart of BAMS technology is its ability to differentiate between biological particles (such as contaminating microbes) and inert ones (such as dust particles) with enhanced precision. This level of specificity is crucial in the cell and gene therapy industry, where even the smallest contamination can have profound consequences. By providing early detection and differentiation of contaminants, BAMS helps mitigate the risks associated with manufacturing these complex therapies, ultimately saving time, money, and most importantly, ensuring a high level of patient care.

Benefits of BAMS in Cell and Gene Therapy Manufacturing:

• Real-Time Monitoring: Provides rapid and accurate detection of microbial contaminants, allowing for immediate corrective action.
• Enhanced Specificity: Differentiates between biological and inert particles with high precision, reducing false positives.
• Cost Savings: Prevents batch loss due to contamination, saving time and resources.
• Improved Efficiency: Streamlines monitoring procedures and minimizes the risk of human error.
• Regulatory Compliance: Aligns with Annex 1 requirements for continuous environmental monitoring.

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