MilliporeSigma's BioReliance® testing services is the leading GMP and GLP testing services provider for the development of your therapeutics. Regulatory bodies such as the US Food & Drug Administrators (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) require products to be tested for compliance before release. Our clients include producers of traditional pharmaceuticals, medical devices, chemicals and other products, as well as biopharmaceuticals.
In biopharmaceutical manufacturing, every product produced for preclinical and clinical studies, as well as the global pharmaceutical markets, require testing to demonstrate regulatory guideline compliance. Our biopharmaceutical testing services use a wide range of tests and technologies to ensure your product is compliant and safe for human use.
Enjoy the benefits of our high-quality customized analytical testing and organic synthesis services spanning a wide variety of compounds and techniques for support of client-specific reference materials.
Whether you’re preparing for first-in-human clinical trials or scaling up for global distribution of a life-changing therapeutic biologic, our cGMP-compliant bulk harvest release testing services protect your investment at every step.
Cell and viral bank testing is an important part of a robust viral detection strategy. We partner with you to conduct a risk assessment and develop strategies for cell line characterization and genetic stability studies.
Our cell culture media stability and testing services can provide an assigned expiration date for custom products, or test for nutritional component data to optimize your bioprocess.
With all biologics released into global pharmaceutical markets requiring GMP testing of final product, we offer a wide range of assays and lot release testing services to help you demonstrate compliance with regulatory guidelines.
Our rapid alternatives to traditional biosafety testing methods can reduce the time and volume requirements that pose barriers for gene-modified cell therapies and other advanced therapy medicinal products, while also helping to mitigate risk and increase facility utilization for established therapies such as mAbs.
Viral Clearance studies are critical to the validation of downstream processes, ensuring viral clearance process steps are effective and reproducible in the biopharma manufacturing setting.