Lab service providers are seeing rising demand for nitrosamine testing, in vitro release and permeation testing, and microbiome database capabilities, according to conversations at recent industry conferences reported by BioSpace on June 25. The trend reflects a growing focus among sponsors on derisking safety and performance quality early in drug development.
Nitrosamines, classified as probable human carcinogens that can form unintentionally during drug manufacturing, have become an area of heightened concern. Samuel Garcia, business development manager at AMSbiopharma, said the company has received more than 10 inquiries related to nitrosamines in excipients, active pharmaceutical ingredients, and final products over the past several months. Regulatory scrutiny has also increased: "In late autumn 2023, the FDA had issued final guidance on the recommended acceptable intake limits for nitrosamine impurities." In April 2024, Novartis paused enrollment of new patients in ribociclib early breast cancer studies due to evolving regulatory guidance on intake limits for nitrosamines.
For topical products, equipment vendors are promoting in vitro release testing (IVRT) and in vitro permeation testing (IVPT) as cost- and time-saving regulatory options following a recent European Medicines Agency guideline. Dr. Michael Felkel, regulatory affairs manager at Dermapharm AG, wrote that "the importance of in vitro tests such as IVRT and IVPT has increased significantly." He added that the EMA guideline considers IVRT a critical quality attribute: “In addition, according to the equivalence concept provided in the EMA guideline, IVRT can be a useful tool for demonstration of equivalence...for so-called simple formulations.” Felkel also pointed out challenges with harmonizing requirements between different regulators: “These include meeting the equivalence criteria of the guideline and lack of harmonization (EMA guideline vs. FDA/USP requirements), which might be critical for globally acting companies.”
Microbiome data is another growing area within lab services. Such data can help identify responders to drugs or illuminate affected biological pathways; however, gut microbial metabolism is often overlooked during drug discovery processes. Providers like Sequential Bio aim to collaborate with contract research organizations; Carla Brown from Sequential Bio noted previous partnerships with service providers in Scotland and the U.K., adding that Sequential Bio raised $3.5 million in its first equity round this March.
Lab service providers say these trends are shifting their role from routine test vendors toward becoming regulatory-savvy partners who help sponsors navigate evolving standards while extracting actionable data.
