YEMASSEE, SOUTH CAROLINA / ACCESS Newswire / October 14, 2025 / Alpha Genesis, Inc. (AGI), one of the United States' largest nonhuman primate research and breeding organizations, today announced a significant expansion of its Good Laboratory Practice (GLP) program following more than $3 million in new infrastructure and personnel investments. The expansion builds on several years of successful GLP operations and was undertaken to meet increasing client demand for IND-enabling toxicology and pharmacokinetic studies conducted under full regulatory compliance.

"Over the past few years, we have conducted a growing number of GLP studies for commercial and government sponsors," said Dr. Xavier Westergaard, Chief Scientific Officer of Alpha Genesis. "We recognized that the biggest challenge many clients face is not finding a qualified partner but getting started quickly. This expansion was about increasing our physical capacity and staffing so that sponsors can initiate a GLP study in weeks rather than months."

AGI's GLP operations are designed to deliver regulatory-grade, audit-ready data packages aligned with FDA 21 CFR Part 58 and OECD GLP Principles. The recent investment strengthens the company's capacity across its entire research infrastructure, enabling faster startup times and greater study volume.

AGI's expanded GLP capabilities include:

• An experienced, fully independent Quality Assurance Unit that provides continuous oversight of study conduct, inspections, and reporting.

• Validated electronic data-capture and archival systems that ensure complete traceability and integrity of regulated data.

• Modernized laboratory and vivarium facilities supporting pharmacokinetic, toxicology, and safety pharmacology studies in rhesus and cynomolgus macaques, with flexibility to accommodate additional nonhuman primate species as required by sponsors.

• Secure documentation controls with real-time QA review, SOP traceability, and version-controlled regulatory documentation.

• Expanded technical staff and enhanced training programs to support simultaneous GLP studies with consistent compliance.

AGI's vertically integrated model, which combines on-site breeding, research, and QA oversight, allows the company to offer industry-leading turnaround times. Sponsors can initiate GLP studies in less than one month, compared to the six months or longer typical at many large CROs.

"Our focus has always been on scientific quality and responsiveness," Dr. Westergaard added. "By expanding our GLP facilities and personnel, we have made it possible for sponsors to begin studies almost immediately while maintaining the same regulatory rigor and data integrity expected by the FDA and OECD."

AGI's continued investment in GLP operations strengthens its position as a leading U.S. contract research organization specializing in nonhuman primate regulatory studies. The company's integrated capabilities support IND-enabling toxicology, pharmacokinetic, and safety pharmacology programs with a focus on quality, transparency, and speed.

About Alpha Genesis, Inc. (AGI)

Founded in 2003, Alpha Genesis is a fully integrated nonhuman primate CRO headquartered in Yemassee, South Carolina. AGI provides comprehensive preclinical research, breeding, and contract study services to pharmaceutical, biotechnology, and academic partners worldwide. Its capabilities span discovery pharmacology, GLP toxicology, safety pharmacology, and translational research, all conducted under strict ethical and regulatory oversight. Visit www.AlphaGenesisInc.com for more information.

Contact Information

Dr. Xavier Westergaard
Chief Scientific Officer
xwestergaard@alphagenesisinc.com

SOURCE: Alpha Genesis, Inc.