From product development to final production, we perform microbiological testing in our cGMP laboratories. A major facet of quality control is testing for bacteria, yeast and mold, and pathogens, including: S. aureus, Salmonella, E. coli, P. aeruginosa, Clostridia, and C. albicans. USP methods, the same as for pharmaceutical products, are used to test the raw materials and/or the finished product for microbial contamination. Microbac’s cGMP microbiology group performs testing as per USP/NF, EP or client methodology. We provide environmental, pharmaceutical water, raw material, API, and product testing support.
Our analytical testing and research services support the development, approval, and manufacture of raw materials and finished products. An experienced team of scientists will work with you to meet your product testing needs and chemical characterization requirements for identification, quantification and impurities of ingredients and materals. Comprehensive solutions, delivered with a focus on customer satisfaction and service, build strong, beneficial, and lasting relationships.
Microbac has the capability to use Next Generation Sequencing (NGS) and quantitative polymerase chain reaction (qPCR) for biosafety and other life science- based testing. These approaches can be employed for adventitious agent detection, assessing the genetic stability of cell lines, virus seed stocks, and cell substrates. Other molecular service offerings include residual host cell DNA testing, analytical protein analysis, and confirming the identity of viral and bacterial seed stocks. Microbac also offers custom NGS services that are specific to customer needs.
The advent of the biopharmaceutical age has opened new avenues of disease treatment and prevention. However, these biopharmaceutical products, such as monoclonal antibodies, recombinant proteins, vaccines, blood derivatives and animal products carry an inherent risk of transmitting infectious viruses due to the source material used, manufacturing processes, and routes of administration, creating a need for a consistent and thorough viral clearance solution. The purpose of a Viral Clearance evaluation is to assess the capability of a manufacturing production process to inactivate and/or remove potential viral contaminants. Experience and knowledge in selecting the most relevant target viruses, appropriate purification steps, and viral clearing agents are critical in the design and implementation of a cost-effective and high-quality viral clearance study.
Environmental surveillance and forensics are critical for the development and manufacture of life science products. Living systems are complex, adaptive and involve at a minimum an understanding of both chemical and microbiological parameters that can range from the molecular to production scale. Microbac understands biological systems and can test for and characterize microbiological contaminants as isolates or mixed samples using both culture and PCR-based technologies. Such testing can provide a comprehensive understanding of processes and the identification of key interactions controlling contamination.