We can perform initial assessments, gap analyses, and audits of your firm or contract manufacturing firms according to the requirements of Title 21; Part 211 of the U.S. Food, Drug, and Cosmetic Act; entitled Good Manufacturing Practice for Finished Pharmaceuticals.
We provide a suite of services for the identification and evaluation of senolytic drug compounds, from cell-based assays to animal models and lifespan studies. Standardized and validated in-house assays are available along with custom or novel analysis techniques.
Wide range of rodent surgical models offered. Both rat and mouse available with capacity of up to 10 mice or 6 rats simultaneously. Previous surgical models include medial meniscus tear models, sciatic nerve crush injuries, in utero surgery, and ischemia/reperfusion injury models.
Xenograft models available in immunocompetent and immunocompromised rodent strains. Systemic or local engraftments performed, with nude models available. End-point capabilities include tumor size tracking, tumor histopathology, or systemic engraftment efficiencies.
Good Laboratory Practices (GLP) are quality assurance standards for nonclinical laboratory studies detailed in Title 21; Part 58 of the U.S. Food, Drug, and Cosmetic Act. We offer compliance services including status assessments and audits.
Our veterinary staff provide a variety of services including general husbandry, functional testing, and clinical endpoint determination. We currently offer rodent services and plan to begin offering large animal services starting in early-to-mid 2018.
Our stem cell services include cultivation, differentiation, and characterization of pluripotent and multipotent stem cells. We have studied a dynamic range of downstream applications spanning functional culture-based assays to in vivo xenograft and disease models.
Our protein engineering services are currently offered for microbial expression systems (E.coli, yeast), and include protein expression, optimizations, functional characterization, and pilot-scale (10L) bioreactor manufacturing.
Our rodent lifespan study services include consulting on study design, comprehensive analytical and biomarker endpoint packages based on intervention strategy, and study execution in our on-site specific pathogen free (SPF) vivarium.
Our drug discovery services include assay development, high throughput drug screening, and hit validation. Using proprietary RecombiPure technology, we support state-of-the-art drug screening of protein-protein and protein-drug interactions.