Product safety in biopharmaceutical manufacturing
Ensuring the safety of monoclonal antibodies (mAbs) production through rigorous product safety testing is crucial for the integrity and efficacy of biopharmaceutical products. Our molecular safety testing methods are designed to effectively detect contaminants, including bacteria, fungi, and viruses, ensuring compliance with stringent regulatory standards. Discover our fast, highly sensitive testing solutions designed to meet the demanding needs of your quality control process, and helping ensure the safety and regulatory compliance of your biotherapeutics.
Mycoplasma detection
Mycoplasma testing is essential for ensuring the safety and quality of biotherapeutic manufacturing and final therapeutic products. Regulatory agencies mandate sensitive and specific testing methods to comply with safety and quality standards. Undetected mycoplasma can compromise the quality, safety, and efficacy of biopharmaceuticals, posing health risks to patients and causing adverse reactions. Contamination during production can reduce yields and lower antibody quality. Thorough mycoplasma testing helps prevent production delays, enables the maintenance of product integrity, and helps ensure the delivery of safe and effective therapeutic antibodies.
Viral contamination testing
Minimize the adverse impact of adventitious virus contamination through in-process risk management testing
Ensuring the safety and efficacy of therapeutic antibodies requires rigorous in-process viral contamination testing, a critical component in biopharmaceutical manufacturing.
Two specific viruses of concern are Mouse Minute Virus (MMV) and Vesivirus. MMV is particularly notorious for its stability and resistance to heat and certain chemicals, posing a common threat to Chinese Hamster Ovary (CHO)-based production processes. Vesivirus, on the other hand, can also significantly compromise the integrity of biopharmaceutical manufacturing.
Implementing advanced viral contamination testing methods helps detect and mitigate these risks early in the production cycle. Doing so helps you maintain high safety standards, ensure regulatory compliance, and protect the quality and efficacy of your final therapeutic antibody products.
Rapid sterility testing
Raw materials and in-process rapid sterility testing in therapeutic antibody manufacturing addresses the need for early and accurate detection of microbial contamination. Traditional methods can take up to 14 days to deliver results. qPCR-based testing functions as a rapid risk assessment tool for detecting bacterial and fungal DNA during the production process. This advanced technique enables the detection of contaminants with higher sensitivity and greater speed, thereby helping to improve the overall quality assurance within biopharmaceutical production processes.
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