Gene Therapy Toxicology

With a mission to help humanity, Lovelace Biomedical is proud to serve clients across the United States as a not-for-profit preclinical contract research organization. Alongside our pharmaceutical and biotechnical partners, we research disease causes and cures—improving treatments, client health, and—ultimately—the quality of life for humanity.

An integral part of our research is the study of toxicology, which ranges from non-GLP investigational toxicology, to GLP regulatory toxicology. Each study consists of a customized design and various Endpoints, including, toxicokinetic, clinical, psychological, immunological, and genetic. Using toxicology to assist with the careful research of gene therapy, Lovelace Biomedical prides itself on being one of the longest-running preclinical gene therapy toxicology programs.

If you’re looking for a partner to pursue gene therapy toxicology, prepare to push the limits. Based in
Albuquerque, NM and serving the U.S., Lovelace Biomedical is the nation’s premier choice for preclinical research, and we can’t wait to partner with you in bettering the medical industry.

At the core of our gene therapy toxicology studies is an evaluation of the safety, efficacy, and biodistribution of gene therapy products—which we’ve expertly conducted for more than a decade. Consisting of experimental design and content of pivotal, pre-IND packages, our preclinical studies adhere to GLP standards in species and provide final reports to submit to U.S. and European regulatory agencies.

  • Focusing on integral endpoints, Lovelace Biomedical carries out the following to evaluate the efficacy, general toxicity, vector biodistribution, gene expression, and immunogenicity for gene therapy products:Simultaneously measure safety and efficacy of gene therapies by developing advanced study
  • designs
  • Evaluation of traditional and non-traditional dosing routes
  • Monitor immune responses to vector expressed protein
  • Measure biodistribution of vector and transgene expression
  • Monitor immune responses to vector or expressed protein

Trusted Expertise, Trusted End Results

Lovelace Biomedical is trusted throughout the country for preclinical research—and the proof is in our achievements. We’ve run complex IND-enabling programs to support gene therapy development for over 10 years and have over 50 scientific staff who are experienced with pre-IND gene therapy programs. Additionally, our 300,000-square foot lab allows us to execute quality research and includes GLP-compliant operations—and finally, as of 2020, Lovelace Biomedical produced an estimated $204 million in sales of gene therapy products. For more information and to inquire about potential partnerships, please contact us online.