Charles River Laboratories International, Inc. (NYSE: CRL) has launched the Retrogenix® Non-Human Protein Library, a first-in-class in vitro tool designed to help biopharmaceutical clients assess off-target binding within a non-human proteome. This innovative library aims to de-risk in vivo studies and facilitate the selection of appropriate non-human species for research.
“Developed in-house using the unique Retrogenix® platform, the new library provides early insights into how therapeutics interact with non-human protein targets in vitro,” said Aidan Synnott, Ph.D., Corporate Vice President of Global Discovery. “These insights are generated without the lengthy timelines and costs associated with ex vivo or in vivo studies, enabling clients to advance to safety studies, clinical trials, and IND applications with highly relevant data and increased confidence.”
Confirming the conservation of potential off-targets across species enhances the interpretability of in vivo results, ultimately reducing risk by ensuring safety studies are conducted in appropriate models from the outset. Along with the non-human protein library, Charles River offers the ability to screen observed human off-targets against suitable non-human homologous proteins, informing the next steps in drug development.
Screening for Off-Target Effects
The Retrogenix® platform boasts the industry’s largest library of human proteins, featuring over 6,500 human plasma membrane and secreted protein clones. This extensive resource provides a reliable screening tool for identifying primary target receptors and assessing potential off-target binding issues. The new non-human protein library enhances this platform, allowing clients to select the right models before starting in vivo studies, thus saving time and contributing to the development of safer, more effective drugs.
Off-target screening is an established aspect of the IND submission process, typically performed through tissue cross-reactivity (TCR) studies. Data from the Retrogenix® platform has become a valuable complementary or alternative data point across various modalities, therapeutic areas, and international regulatory agencies.
Driving Innovation in the 3Rs
Designed in silico and synthetically generated, the biosynthetic non-human protein library emphasizes the principles of the 3Rs—Replacement, Reduction, and Refinement—by leveraging technological innovations to advance research responsibly.
“The integration of the Retrogenix® Non-Human Protein Library into our drug discovery portfolio enhances the precision and effectiveness of lead candidate selection,” stated Professor Julie Frearson, Ph.D., Corporate Senior Vice President & Chief Scientific Officer. “Technology is fundamental to innovation, and as we drive change in drug development, these advancements allow us to refine our use of research models while supporting the discovery of novel medicines.”
In alignment with its commitment to the 3Rs, Charles River has initiated the Alternative Methods Advancement Project (AMAP), focusing on scientific and technological innovation to advance animal alternatives in research.
About the Alternative Methods Advancement Project (AMAP)
The Alternative Methods Advancement Project (AMAP) is a Charles River initiative dedicated to developing alternatives to reduce the use of animals in testing. As we enter the next frontier of drug development, AMAP will facilitate strategic and purposeful investing to lead the way toward a future where more patients receive needed treatments and medicines safely, swiftly, and successfully. In keeping with our commitment to the 3Rs, we are dedicated to pursuing scientific and technological innovations to explore new and exciting ways we can further reduce the use of animals in testing. The guidance of AMAP will help us align our investments, partnerships, product and service initiatives, and advocacy efforts as we focus on our goal of investing $300 million over the next five years to further enhance this critical mission and drive industry-wide adoption of alternatives.
About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them.
