Gene & Cell Therapy

Gene and cell therapy is the confluence of genetics, cell biology, virology, and immunology enabling the treatment of complex diseases.

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 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.

Example Presentations:

Mohar, I; Lewandowski, T. 2021. “Toxicology-based Exposure Limits for Residual HEK-293T Cell DNA and Protein.” Presented at American College of Toxicology (ACT) 42th Annual Meeting.

Mohar, I; Lewandowski, T. 2020. “Risk Evaluation of Residual Recombinant Lentiviral Vector Capsid Protein p24.” Presented at American Society of Gene and Cell Therapy (ASGCT) Annual Meeting.

Mohar, I; Molloy, M. “Qualifying Biotherapeutics for Host Cell Residuals: What You Don’t Know Could Hurt You.” Gradient Webinar.

Mohar, I; Lewandowski, T. 2019. “Considerations for Qualifying VCN in Cell-based Therapies.” Presented at American Society of Gene and Cell Therapy (ASGCT) Annual Meeting.

What We Do:

Monograph Research

  • Safety considerations for vector and drug products (VCN, integration, biodistribution, oncogenicity)
  • Manufacturing components

Toxicology-Based Exposure Limits

  • Risk assessment (cell lines, antibodies, plasmid DNA, media components)
  • Manufacturing and release criteria
  • ICH-based methodology

Nonclinical Toxicology Support

  • Lab selection/cost-estimates
  • Program development
  • Study monitoring and interpretation
  • IND preparation
  • Novel cell/tissue analysis (protocols, isolation, flow cytometry)

Environmental Safety Assessments

  • Viral shedding
  • Genetically modified organisms
  • Manufacturing release


Related Services

Our Team