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AAALAC-accreditedUSDA-licensedOLAW-assuredPreclinical research & animal resources for global programs +1 (843) 589-5190 info@alphagenesisinc.com
Research animal retirement and lifetime care, now available through Alpha Genesis. Professionally managed lifetime care for retired research primates, with expert social reintroduction into stable outdoor groups led by veterinary staff deeply experienced in laboratory-animal medicine.
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Program
Alpha Genesis evaluates the safety profile of a candidate in rodent and nonhuman primate models, from early dose-range finding through definitive repeat-dose toxicology. Studies are designed to generate the endpoints that support development decisions and regulatory submission.
A safety program answers a defined set of questions: what happens across the dose range, which organs are affected, whether findings reverse, and what margin exists relative to the intended exposure. We design each study around those questions.
Toxicology, safety pharmacology, pathology and clinical laboratory work are run and read together, so the safety picture holds up as a single body of evidence when it moves into a development decision or a regulatory submission.
What this program covers
The in vivo work, the clinical laboratory and the pathology all sit inside Alpha Genesis, so the program is designed and delivered as a connected whole.
Acute, subacute and chronic studies across dose levels in rodent and nonhuman primate models.
Cardiovascular, respiratory and central nervous system evaluations to characterize functional effects.
Early studies that set tolerated dose levels and inform the design of the definitive program.
Hematology, clinical chemistry, coagulation and urinalysis read at scheduled intervals.
Tissue processing, microscopy and board-certified pathology read-outs on target and off-target organs.
Continuous ECG, blood-pressure and body-temperature monitoring integrated into study endpoints.
Anti-drug antibody and neutralizing-antibody assessment for biologics and other large molecules.
Scheduled and terminal necropsy with organ weights, gross observations and tissue archiving.
Studies conducted to GLP for regulatory submission or as non-GLP work to inform internal decisions.
Where it leads
The definitive GLP toxicology and safety pharmacology studies form the safety section that supports a first-in-human submission. When a candidate is ready to move toward the clinic, the same team carries the safety work into the full IND-enabling program.
Discuss your program
Tell us what you are developing and the decision the safety data needs to support. Our scientific team will review it and follow up to discuss the study plan, including whether GLP or non-GLP work fits the stage of your program.