Gradient

Gene and Cell Therapy

Overview
Example Projects

Overview

Gradient supports the development of gene and cell-based therapies at all stages, including R&D, manufacturing, preclinical, and clinical.  Gradient scientists provide comprehensive research and risk assessment support, and assist our clients with understanding and conducting toxicological evaluations of these treatments and the related manufacturing processes.

Gradient's diverse team of toxicologists, risk assessors, industrial hygienists, and environmental scientists and engineers are able to provide expert advice on a broad range of topics.  We provide our clients with high-quality tailored work products that can be as in-depth or high-level as needed.  We take seriously matters of intellectual property and confidentiality.  We understand the time-sensitivity of submissions and the reality of moving deadlines, and can respond quickly to emergent issues and questions. 

“New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses." FDA Commissioner Scott Gottlieb, M.D., from "FDA approval brings first gene therapy to the United States"

Gene DNA Cell

 

Example Projects

Permissible Exposure Limits for Biological Drug Manufacturing Residuals

Full Description

Gradient conducted human health risk assessments for potential impurities and residuals in cell-based cancer treatments. Our monographs included a comprehensive review of the issues and regulations, toxicology and clinical data, and, when possible, a permitted daily exposure (PDE) limit.

Human Health Risk Assessment of Laboratory Cell Line

Full Description

Gradient identified and evaluated potential human health hazards associated with a mammalian cell line used to produce gene-therapy viral vectors. The information was used to inform manufacturing guidance and as support for regulatory applications.

Critical Evaluation of Vector Integration in Gene-modified Cells

Full Description

Gradient conducted a critical evaluation of known and hypothetical risks associated with viral vector-mediated gene modification of cells. We reviewed and integrated the available data and provided the client with science-based justification on target modification and qualification of the drug product.

Critical Review of Anti-CD28 Antibody Toxicology

Full Description

Gradient conducted a critical review and human health risk evaluation of anti-CD28 antibodies and antibody fragments (Fabs). Based on the available nonclinical and clinical toxicology data, we provided a summary of the potential human health effects and toxicology-based exposure limits for specific anti-CD28 antibodies.

Immunology of Novel Skin Cancer Treatments

Full Description

Gradient evaluated flow cytometry data to gauge human immune responses to skin cancer treatments. We aided in the development of new assays to better understand dermal tumor immunology.