Toxicology


AAALAC Accredited
Animal Facilities

70+Years Toxicology Experience

Custom Study Designs & Specialty Routes Available

Lovelace Biomedical is a globally recognized leader in general and specialized toxicology. Our team conducts a full range of toxicology studies under both Good Laboratory Practice (GLP) or non-GLP guidelines. We integrate quality, leading-edge expertise in non-standard dosing routes, and evaluation of routine and novel endpoints to meet study goals.

Key Capabilities


    • Experience with small molecule, biologic (antibody, protein, peptide, siRNA, ADC), gene therapy and cell therapy programs
    • IND-, NDA-, BLA-enabling safety programs
    • Expertise in wide range of dosing methods, including IV, PO, SC, IM, IP, IA, IT. Industry leader in inhalation, intra-tracheal and intranasal delivery
    • Wide range of dosimetric (including tissue-specific compound analysis), toxicokinetic, clinical, physiological and genetic assays
    • Full spectrum of safety pharmacology endpoints and studies, including telemetry systems
    • Experienced study directors with more than half of the team at the Ph.D. level
    • Full histopathology, immunohistochemistry, and morphometric capability
    • Integrated bioanalytical capabilities including method development and method transfer
    • Single site location to accomplish all study activities under one roof by a dedicated team
    • Industry-leading animal behavioral management and enrichment program
    • AAALAC-accredited animal facilities
    • SEND-compliant dataset generation

  • Laboratory Building Icon
    300,000 square feet of laboratory space
  • Award Winning Medal Icon
    50+ cross-trained research technicians
  • Research Staff Icon
    500+ Staff centralized in Albuquerque, New Mexico
  • Calendar Icon
    70+ Years of toxicology experience
Download our Toxicology Fact Sheet

IND-Enabling Programs

Lovelace Biomedical has an extensive record of successfully designing and executing regulatory toxicology studies for submission to U.S. and European regulatory bodies, including the FDA and EMEA, with capabilities to address regulations of other countries, as well. Our toxicology, bioanalytical, pathology and genetic toxicology capabilities are combined in a centralized facility, allowing us to efficiently conduct an array of IND-enabling studies.

Our scientists work closely with sponsors to design programs that achieve their goals while minimizing timeline and investment. Beginning with non-GLP investigational toxicology and dose-range finding studies, we focus on generating the data needed to support regulatory submissions. Our team is recognized for its excellence in tackling the many challenges of highly innovative drug classes and new delivery mechanisms, while also bringing the experience and foresight to proactively address the many unseen complexities of seemingly routine programs.

Highlights


Species

  • Canine
  • Non-human primate
  • Rat
  • Mouse
  • Ferret
  • Hamster
  • Gottingen, Yucatan or Yorkshire swine
  • Guinea pig
  • Rabbit

Routes of Administration

  • Standard routes: IV, IM, IP, SC, PO, Dermal
  • Inhalation (nose-only, head-only or whole body)
  • Nasogastric
  • Arterial (hepatic artery, carotid artery or femoral artery)
  • Intravenous infusion: Bolus, intermittent, continuous
  • Intracerebral, intraventricular or intrathecal

Endpoints

  • Serum chemistry, hematology
  • Telemetry (HR, BP, ECG, etc.)
  • Serum or tissue-based biomarkers
  • Clinical Pathology / Hematology
  • Histopathology
  • PK / TK and biodistribution
  • Ocular pharmacology and toxicology
  • Imaging
    • Radiography
    • SPECT
    • MRI / fMRI