Loading…
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.
Learn more
Program · By modality
Alpha Genesis runs preclinical programs for AAV and other vectors, characterizing where the vector distributes, whether the transgene is expressed, and how the immune system responds. Specialized delivery routes and nonhuman primate models for central nervous system and systemic administration are performed in house under veterinary oversight.
For a vector-delivered therapy the central questions are delivery and distribution: where the vector reaches, at what genome copy number, and how much clears or sheds over time. Alongside that sits expression, whether the transgene produces its intended product in the target tissue, and the immune response to both the capsid and the transgene product.
Safety follows from those answers. The biodistribution, expression, immunogenicity and pathology data are generated and read together, so the program reads as one connected body of evidence rather than a set of separate studies.
What this program covers
The dosing, the molecular read-outs and the pathology all sit inside Alpha Genesis, so the vector biology and the safety picture are built by the same team.
Vector genome copies quantified across target and non-target tissues, with shedding assessed in serum, urine and other matrices over time.
Expression of the delivered transgene measured at the RNA and protein level in the tissues the vector is designed to reach.
Humoral and cellular responses to the capsid and to the transgene product, including pre-existing neutralizing antibodies where the design requires it.
Intravenous, intrathecal, intracisternal and intraparenchymal administration performed under veterinary oversight with anesthesia and recovery management.
Nonhuman primate models for central nervous system and systemic delivery, with cohorts matched by serostatus where the program calls for it.
Early proof-of-concept work in disease-relevant rodent models to confirm activity before translational studies begin.
Single- and repeat-dose safety evaluations across dose levels, with GLP and non-GLP options matched to the stage of the program.
Histology, immunohistochemistry and board-certified pathology read-outs on the nervous system, dorsal root ganglia, liver and other target organs.
qPCR, ddPCR, ELISA and cellular assays that quantify vector, transgene and the biological response together.
Where it leads
Biodistribution, shedding, expression and immunogenicity form the core of the nonclinical picture a first-in-human submission relies on. When a vector is ready to move toward the clinic, the same team carries the work into the definitive safety and IND-enabling program. The in-life delivery and bioanalytical methods behind it are described on the gene-therapy capability page.
Discuss your program
Tell us about the construct, the delivery route and the decision the data needs to support. Our scientific team will review it and follow up to discuss the study plan, including the models, the dosing approach and whether GLP or non-GLP work fits the stage of your program.