Featured News
Monoclonal Antibodies: Science in Motion
Experts weigh in on NAMs, innovation, and monoclonal antibodies testing
As recent FDA guidelines signal a shift toward New Approach Methodologies (NAMs) and advanced in vivo approaches, monoclonal antibody (mAB) development is entering a new era. Charles River shares the FDA’s vision to streamline drug development, foster innovation, and promote responsible animal use. While the industry cannot yet fully move beyond animal models, we are investing in technologies and collaborative study designs that integrate NAMs and validated in vitro approaches.
Balancing Progress and Practicality
Regulatory updates around NAMs have sparked both excitement and questions among developers.
There’s excitement and optimism, but also some anxiety. While there’s acknowledgment that alternatives exist for evaluating antibody safety, the roadmap isn’t yet well defined.”
Lauren Gauthier, Head of Nonclinical Toxicology, Oncology and Cell Therapy, Takeda
The panel agreed that collaboration with regulators is key to translating early innovation into consistent global practice.
“Developers shouldn’t be afraid to approach regulatory authorities with innovative ideas,” noted Pramila Singh, Senior Principal Scientific Advisor at Charles River. “It’s an exciting time—science-based approaches are being encouraged.”
Dispelling Misconceptions in Monoclonal Antibodies
Even with decades of progress, antibody development still faces enduring misconceptions.
There’s a belief that monoclonal antibodies are always safe. Most toxicities are on-target, but off-target effects can still occur. Understanding your target and mechanism of action remains critical.”
Beatrice Gautier, Veterinary Toxicology Pathologist, Sanofi
Mary Ellen Cosenza, President of MEC Regulatory & Toxicology Consulting, added: “Sometimes the target is present in places we don’t expect it to be. Even with advanced profiling, there can be surprises.” These candid reflections emphasize that strong science and deep biological understanding remain central to antibody safety.
Discuss your needs with one of our experts and see how we can support and optimize your antibody development.
1FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal Antibodies