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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 · By modality
Antibodies, proteins and peptides often bind a target with the affinity needed to read a meaningful profile only in the nonhuman primate, which makes it the pharmacologically relevant species for much of this work. Alpha Genesis pairs that model with pharmacokinetics by validated immunoassay and careful immunogenicity assessment, so exposure and immune response are read together.
A biologic is characterized by its target biology. When the candidate binds the human target but not the rodent equivalent, the nonhuman primate is frequently the only species in which pharmacology and safety can be read at a clinically relevant dose, so the program is built around that model with rodent work included where it is informative.
Large molecules also raise questions that small molecules do not: whether the animal raises an immune response to the candidate, how binding to the target shapes clearance, and how the immune system itself responds. We design each study so exposure, immunogenicity and immune endpoints are generated and interpreted as one connected read-out.
What this program covers
The nonhuman primate work, the ligand-binding bioanalysis and the immune and pathology endpoints all sit inside Alpha Genesis, so the program is designed and delivered as a connected whole.
For many antibodies and proteins the nonhuman primate is the pharmacologically relevant species, expressing a target that binds the candidate with the affinity needed to read a meaningful safety and exposure profile.
Quantitation of antibodies, fusion proteins and peptides by validated ligand-binding immunoassays, with LC-MS/MS applied where a peptide or small protein is better measured by mass spectrometry.
Tiered anti-drug antibody assessment with screening, confirmatory and titer assays, and neutralizing-antibody evaluation, interpreted alongside exposure to explain shifts in clearance.
Study designs that account for target-mediated drug disposition, where binding to the target drives nonlinear pharmacokinetics across the dose range and shapes the sampling schedule.
Cytokine measurement and cytokine-release assessment for candidates that engage immune effector function, read against baseline and across scheduled time points.
Flow-cytometric immunophenotyping of circulating lymphocyte and leukocyte populations to characterize pharmacologic and off-target effects on the immune system.
Subacute and chronic repeat-dose toxicology in the nonhuman primate at clinically relevant dose levels, with recovery cohorts to assess reversibility of findings.
Tissue distribution and clearance for modalities where the question applies, informing exposure at the intended site of action and in clearance organs.
Hematology, clinical chemistry and coagulation with board-certified toxicologic pathology, including a high-level view of tissue cross-reactivity for antibody candidates.
Where it leads
The pharmacokinetic, immunogenicity and immune data developed here feed directly into the repeat-dose toxicology and safety work that supports a first-in-human submission. When a biologic is ready to move toward the clinic, the same team carries the program into safety and toxicology and the full IND-enabling package, with GLP applied to the definitive studies where the submission requires it.
Discuss your program
Tell us what you are developing, the species in which your target is expressed and the decision the data needs to support. Our scientific team will review it and follow up to discuss the study plan, including the immunoassay strategy, the immunogenicity approach and whether GLP or non-GLP work fits the stage of your program.