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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 helps sponsors move from exploratory work toward the studies and data an IND requires. We plan the program, select the models and doses, run the rodent and nonhuman primate work and assemble the package on one timeline.
An IND rests on a set of nonclinical studies that fit together: the right species, the right doses, and safety, exposure and pathology data that read consistently across the program. We plan those studies as one body of work rather than a set of separate tests.
Alpha Genesis coordinates the planning, in vivo execution, bioanalysis, pathology and reporting on a single timeline, so the data you generate is the data your regulatory team can build on. GLP and non-GLP options are available across the program.
What the package includes
From program planning through study sequencing and reporting, the work sits inside Alpha Genesis and runs on one timeline.
We map the studies and data needed to support an IND and set the order in which they run.
Rodent and nonhuman primate model selection based on the biology of the candidate and the endpoints required.
Dose-range finding and tolerability work to set the levels carried into definitive studies.
Single and repeat-dose pharmacokinetics, toxicokinetics, exposure-response and target engagement.
Acute and repeat-dose toxicology studies, with GLP and non-GLP options available.
Cardiovascular, respiratory and central nervous system safety endpoints integrated into study design.
Quantitation by LC-MS/MS and ligand-binding assays, with method development and validation.
Necropsy, histology, immunohistochemistry and board-certified pathology read-outs.
Hematology, clinical chemistry and coagulation endpoints across dose levels and time points.
Tissue distribution and clearance across dose levels and collection time points.
Anti-drug antibody and immunogenicity sampling built into the study schedule where indicated.
We sequence the studies and deliver the reports and data package that document the program.
One organization
The value of the package is in how the studies connect. Dose-range work sets the levels for the definitive studies; PK and toxicokinetics tie exposure to the safety findings; pathology and clinical pathology are read against the same design. When one organization runs the program, those links hold.
Alpha Genesis plans the sequence, runs the rodent and nonhuman primate work and reports the results as a single line of work, so the package arrives coordinated rather than reconciled after the fact.
IND-enabling development is the stage where earlier discovery and safety work converge into a submission-ready package. See how the full program runs under one team.
Integrated Preclinical DevelopmentDiscuss your program
Tell us about the candidate, the target indication and the timeline. Our scientific team will help you scope the studies and sequence the work that builds toward your IND.