To deliver on the mission of improving health and improving lives, patients need access to safe and effective treatments. As part of safety testing, abnormal toxicity tests, also known as general safety tests, are often performed when a drug manufacturer creates a batch of its licensed pharmaceutical or biotechnology-derived product.
Even though manufacturing follows a strict quality control process, abnormal toxicity testing can detect unexpected issues, such as contaminating impurities, the decomposition of products, or a change in production processes, all of which can cause increased toxicity of an approved drug.
Drug manufacturers often rely on CROs like us for their abnormal toxicity testing. Al Catalano, our Operations Manager II of BioCMC, shared a few insights for finding a partner to support this test for quality and safety.
Supporting testing for global pharmaceuticals
“For products that are already marketed, many European pharmaceutical companies are looking for a partner in the U.S. that can support their general safety testing,” explained Al. “The Medicines and Healthcare products Regulatory Agency (MHRA) audited our GMP lab at our Greenfield site so we are approved to support drug manufacturers in the EU and U.S.”
This partnership works through a mutual recognition agreement between the MHRA and the FDA. Testing in the U.S. is permitted for product release in Europe, where this type of in vivo testing has been largely discontinued.
“Manufacturers are looking for a testing partner that has a solid quality management system as well as a high level of experience and training,” said Al. “Our team follows current or cGMP regulations and can help manufacturers understand any of the requirements of USP compendial monographs. We can also help them through feasibility, validation, and batch release protocol development and testing to develop specific and or generic methods for this analysis of their product(s) together based on our 30 years of running these assays and customize their safety testing, as needed.”
USP reference testing beyond abnormal toxicity
The Greenfield BioCMC team also offers several other methods, such as
- USP <121> Insulin bioidentity/biopotency
- USP <123> Glucagon biopotency
- USP <88> Biological reactivity tests, in vivo
“The industry has been transitioning some of these methods to cell-based assays,” added Al. “But it is important to note that some countries won’t accept in vitro alternatives and will only accept in vivo test results. However, by offering both types of testing, we can give sponsors more choices in their safety testing. And, we can a wide range of services, from cell-based assays for protein chemistry, mass spec and other related solutions to support GMP batch release.”