Manufacturers must provide evidence that their manufacturing process will effectively remove and/or inactivate biological agents known to contaminate source materials (microbial contaminants). This requirement extends to organisms other than viruses.
BioReliance routinely performs clearance evaluations of manufacturing operations for the reduction of microbial contamination for a wide range of microbes including:
The ICH Q5A regulatory guideline and 21 CFR Part 11 indicate that a manufacturer of biological products for human use should demonstrate manufacturing processes are free of microbial contaminants.
BioReliance research professionals have performed thousands of microbial contamination tests and microbial monitoring for clients in Biopharma. We can provide a fast turn around time and the highest quality testing to produce therapeutics that are microbe free and safe for use in humans.
Contact us for more information on how our microbial contamination services can meet your project needs.
What steps during the manufacturing process require microbial contamination testing?
Biological products and therapeutics, such as pharmaceuticals, medical devices, diagnostics and personal care products, have historically operated under very different GMPs. However, the considerations for microbial contamination control and monitoring are very similar. Development of a contamination control plan is critical to the success of the manufacturing process.
Multiple steps require microbial contamination testing including:
- Initial Start-up
- Ongoing Operations
- Pre-clinical Trials
- Regular Maintenance
One particular area of potential contamination is incoming bioburden. All raw materials used in the manufacturing process must be tested for microbial contamination, including any water used in the process.
BioReliance is one of the world’s leading CROs, offering multiple assays aimed at detecting microbial contaminants.
Custom assays also are available for your project needs – contact a scientist or use the search tool to the right.
What types of products require microbial contamination testing?
Elimination of contaminating bioburden is a crucial step in the manufacturing of any biological product. Residual contamination and batch cross-over can set a manufacturing process back months or even years.
BioReliance has a vast experience in microbial contamination testing of the following products:
- Human and bovine blood products and coagulation factors
- Equine and ovine blood products
- Human and animal urine derived products
- Tissue derived products
- Monoclonal antibodies
- Recombinant products
- Medical Devices (including collagen-derived products)
BioReliance is one of the world’s leading CROs, and can provide individualized microbial contamination testing, specific for your therapeutic or manufacturing process.
If you don’t see your particular biologic listed above, contact BioReliance for personalized assistance from one of our microbial contamination experts.
What types of assays are used to detect microbial contaminants?
Regulatory guidelines demand that therapeutics be tested for microbial contamination before production and distribution. Culture based methods combined with molecular methods are used to meet the turn around time needs of therapeutic production.
A confounding factor in microbial contamination of therapeutics is the presence of bacterial genomic DNA. Culture based methods alone will not detect this contaminating source.
BioReliance offers multiple assays for the detection of microbial contaminants including:
- Nutrient agar based culture
- Western blot analysis
- Real-time endpoint testing
This combination of assays achieves detection of low-level contaminants of multiple species of microbes. Due to the biological amplification of Q-PCR, BioReliance is able to add increased sensitivity, specificity, and speed to the detection of microbial contamination. These assays are performed under cGMP and have been validated to current ICH guidelines.
To find the microbial contamination assays you need, use the search tool to the right or contact one of our research staff here.