At Nelson Labs we perform a variety of tests to support chemistry, manufacturing, and controls (CMC) for pharmaceutical and biopharmaceutical products from drug development through commercialization and life-cycle management.
We can support your internal quality processes, including sterility (USP 71) testing in a cleanroom or isolator, particulates (USP <787> and USP <788>) testing using a variety of methods, bacterial endotoxin, filter validations, container closure integrity testing (CCIT), and USP compendial testing. We have the expertise to support this testing whether the product is terminally sterilized with gamma, e-beam, or ethylene oxide (EO).
We also provide analytical services, such as stability studies, stress studies, organic impurities identification and characterization, and testing for extractables and leachables (E&L) and elemental impurities (USP <232> and USP <233>).
Additionally, we provide quality control of active pharmaceutical ingredients (APIs), starting material, intermediates, finished products, impurities, and degradation products.
View any of the fact sheets listed below to learn how we can support commonly required tests for pharmaceutical and biopharmaceutical products .
- Microbiological Testing for Pharma & BioPharma Products
- Raw Materials & Container Closure Integrity Testing for Pharma & BioPharma Products
- Residual Solvents & Elemental Impurities Testing for Pharma & BioPharma Products
- Stability Management for Pharma and BioPharma Products
- Sterility Testing of Parenteral & Ophthalmic Drug Products in Support of Your Sterility Assurance Program
We can also help to support your facility with environmental and water system testing and validate cleaning processes inside the cleanroom. Together with our sister company Sterigenics, we can help you evaluate alternatives to aseptic processing with a variety of terminal sterilization methods.
We have a long history of partnering with pharmaceutical and biopharmaceutical companies. We have over 700 scientists, technicians, and service specialists performing the tests listed above in multiple labs around the world. With our decades of expertise we stand behind the quality of our results and the strength of our customer partnerships.
Learn more about the major testing categories for pharma and biopharma below.