Preparing For Future Changes To USP <87>: What Customers Should Know Today

By Jillian Miller, Microbiology Manager at Pace® Life Sciences

With revisions to USP <87>, Biological Reactivity Tests, In Vitro, expected to be released in December 2026, organizations involved in pharmaceutical, healthcare, and medical technology applications should begin assessing how evolving requirements may affect material qualification, supplier oversight, and biological evaluation strategies. Current testing approaches—including agar diffusion, direct contact, and elution methods—have long supported the assessment of biological reactivity in mammalian cell cultures, but future frameworks are expected to incorporate more advanced in vitro technologies and risk-based decision-making.

Industry trends point toward greater use of quantitative cell viability measurements, enhanced biological screening methods, and scientifically driven testing strategies that generate deeper insights into material-biological interactions while supporting broader efforts to reduce reliance on animal testing. These developments are not expected to create a one-size-fits-all testing model, but rather encourage approaches tailored to product risk and intended use.

Organizations that evaluate potential impacts now can better prepare for future implementation, minimize qualification risks, and maintain continuity across development and commercial programs as regulatory expectations evolve.