Chinese contract research organization GemPharmatech has expanded its presence in the United States with a new facility in San Diego, announced on April 17. The facility is designed for laboratories and housing genetically engineered mouse models, aimed at enhancing their capabilities in offering lab rental space, mouse breeding, and in vivo preclinical studies. This move is part of GemPharmatech’s strategy to grow its U.S. business from Nanjing, China.
This expansion comes in response to the FDA’s April 10 announcement to phase out animal testing requirements for monoclonal antibodies. This decision has created significant reactions within the industry. While GemPharmatech continues to focus on its advanced genetically engineered mouse models, it is also exploring new alternative methods due to changing demands.
Other contract research organizations, such as Charles River Laboratories, are also reacting to these changes. Charles River plans to adopt new alternative methods involving computer models and human organoids by April next year. They are exploring innovative methods such as virtual control groups and AI technologies to reduce animal testing. Despite an initial drop in stock prices, the broader industry sentiment remains optimistic about transitioning to these new methods.
Jim Corbett, CEO of organ-chip company Emulate, believes the FDA’s announcement serves as an incentive for the industry to adapt gradually to advanced technologies. Certara, a drug developer, has also announced a new service to assist biopharma clients in moving away from animal testing, offering regulatory advice, preclinical development planning, and biosimulation technology.
In conclusion, the CRO industry is undergoing significant changes following the FDA’s decision to phase out animal testing for specific drugs. Companies like GemPharmatech, Charles River Laboratories, and others are investing in alternative methods, indicating a shift towards innovative testing technologies to meet evolving market demands.
