Regulation of Biological Products and Biopharmaceutical Products
Biological products comprise a wide array of products, all of which are regulated in the US by FDA’s CBER (Center for Biologics Evaluation and Research) division and include regulation of blood, blood components, bioassays biosmiliars, biobetters, and biotherapeutics. While biologicals like blood and blood components have long been regulated, regulation of biosimiliars and biopharmaceuticals is relatively new.
With regulations comes the need for testing to ensure regulations are being adhered to. As biologic comes from biological materials, there are different requirements for their development and testing than there are for traditional pharmaceuticals. Unlike traditional drugs which have exact known chemical structures, biological products makeup and structure are not as easily identified
For a biologic product to gain FDA approval, it must follow a similar approval process as pharmaceuticals. First, there must be laboratory and animal testing to ensure the safety and accuracy of the product. After initial testing the product must be studied in human clinical trials. Once a successful clinical trial has been completed, meaning the product was found safe and effective for the intended use, all testing and trial data is sent with a biologics licensing application to the CBER to await approval for marketing.
Sometimes CBER will perform confirmatory tests on lots of biological products or perform their own research regarding a products safety, purity, and effectiveness. So as to not run into any issues, it is important to perform thorough testing of biologics during the testing and clinical trial phase.
For more information regarding FDA’s CBER office, visit their website.
Biological Product Test Requests Received by Contract Laboratory
- Large biologics company needs GLP toxicology laboratory for human health and safety testing as follows: acute oral infectivity and toxicity, acute pulmonary infectivity and toxicity, intravenous infectivity, acute dermal toxicity, dermal irritation, and genotoxic potential for 16 samples including 4 studies for end products and 12 studies for bacterial actives.
- URGENT. LONG TERM TESTING. Biologics company needs bioanalytical laboratory for carbonic anhydrase activity testing in red blood cells.
- Bioanalytical laboratory needed for biologics testing for residual simethicone from antifoam treatment in fermentation process for biological product for human use
- Medical device company needs virology laboratory for virus testing of surgical products Biologics
- Europe GMP bioanalytical laboratory needed for physiochemical testing of biologics: pH, Osmolality, appearance, LC based methods Bioassays: ligand binding and cell based assays
- LONG-TERM TESTING Pharmaceutical company needs product safety laboratory for General Safety Test of Biologics Testing as described in CFR 21 610.11 GENERAL BIOLOGICAL PRODUCTS STANDARDS, . Aproximately 800 tests annually
- Bioanalytical lab needed for non-GMP ESR testing on biological products
Contract Laboratory has hundreds of test requests that can be seen here! If your research organization is looking for a laboratory to perform research or testing of a biological product, submit a test request on our website!
Originally posted 2017-06-07 13:45:23.