The success of modern biologics depends not only on groundbreaking science but on the robustness, speed, and credibility of the testing programs that support them. Across the industry, long established testing paradigms are being re-examined as new modalities emerge, regulatory agencies promote innovation and animal reduction, and development timelines continue to compress.
Charles River publishes The State of Biologics Testing 2026 to help document and interpret this moment of change. Based on Charles River’s deep involvement in biologics testing worldwide, and informed by interviews with leaders across biopharma, quality, and regulatory functions, the report captures how organizations are navigating the transition—from traditional compendial methods to advanced technologies, digital tools, and risk-based approaches.
This report is intended to inform discussion and decision making, not to prescribe solutions. Produced in collaboration with GEN, it reflects the collective voice of an industry adapting to new scientific and regulatory realities.
