Gene Therapy Toxicology: Download
Gene Therapy
Gene Therapy Toxicology
Lovelace Biomedical has one of the longest-running gene therapy toxicology programs of any contract research organization, with more than a decade of experience conducting preclinical studies to evaluate safety, efficacy and biodistribution of gene therapy products.
Lovelace gene therapy toxicology program consults on experimental design and content of pivotal, pre-IND packages and provides final reports for submission to U.S. and European regulatory agencies. Preclinical studies in gene therapy are run in compliance with GLP standards in species ranging from rodents to nonhuman primates.
What We Do
- Develop novel study designs to concurrently measure safety and efficacy of gene therapies
- Monitor immune responses to vector or expressed protein
- Measure biodistribution of vector and transgene expression
- Evaluate traditional and non-traditional dosing routes
Endpoints That Matter
- Efficacy
- General toxicity
- Vector biodistribution (qPCR)
- Gene expression
- Immunogenicity
10+ Years
running complex IND-enabling programs to support gene therapy development
50+
lovelace Biomedical scientific staff experienced with pre-IND gene therapy programs
300,000
square feet lab space, including GLP-compliant operations
$204 million
estimated sales of gene therapy products in the U.S. by 2020
Lovelace Biomedical is the leading CRO for performing Gene Therapy nonclinical development. We have been working with the FDA and scientists with leading pioneers in the industry to advance gene therapy products to the clinic for over 12 years. In 2007 our Gene Therapy pharmacology/toxicology Center was established by the NIH along with pioneers at the University of Pennsylvania. We have maintained this core for over 12 years, and have built on its foundation a successful resource for biotechnology and pharmaceutical companies aiming to advance their candidates from discovery to clinical stage by GLP enabling studies as rapidly as possible.
Gene Therapy Toxicology Expertise
End Points
- PCR Development & Validation
- Biodistribution & Gene Expression
- Clinical Pathology/Histopathology
Regulatory Support
- Pre IND
- Pre IND Package Development
Specialized Dose Delivery
- Inhalation
- Intra-Articular
- Cerebral
- Epicardial
- Ocular
- Intravenous Infusion
- Spinal
Disease Models
- Animal Model Propagation
- Animal Model Development
Animal Models
- NHP
- Canine
- Swine
- Rabbit
- Ferret
- Guinea Pig
- Rat
- Mouse
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