Cell and Gene Therapy Solutions

Through specialized expertise in cell and gene therapy, coordinated capabilities and impactful innovation across pre-clinical, clinical and post-approval phases, we’ll help you to reduce the time and risk in your therapeutic’s development.

  • Supported development of three FDA approved CAR T therapies

  • Helped to advance the first two FDA approved gene replacement therapies

  • More than 20 years of delivering development solutions for cell and gene therapies

Cell and Gene Therapy Education Center
Your Needs

Developing a cell or gene therapy is a uniquely complex process requiring specialized scientific, regulatory and logistical insights and capabilities. Whether you’re developing a viral (such as AAV) or nonviral-based gene therapy, an adoptive or autologous cell therapy, a stem cell therapy or other type of regenerative medicine, your program will face challenges that can delay or even derail your therapeutic’s development.

Overcome these challenges with the help of the Covance cell and gene therapy team and its coordinated, global capabilities that offers unparalleled technical, regulatory and commercialization expertise. Coupled with our program management, consultation and renowned capabilities in biomarkers and companion diagnostics, you can obtain comprehensive, integrated solutions that address the unique needs of your program.

By working with one CRO partner, you can trim your development timeline, simplify an already complex program and mitigate potential risks inherent to a program split across multiple vendors. In addition, with numerous expedited regulatory review and approval pathways, such as the Regenerative Medicine Advanced Therapy (RMAT) designation, a compressed and shortened development program may be possible. Let us help align and optimize your development plan and create a long-term, strategic vision for your program that will accelerate your cell and gene therapy’s development.

Staying ahead of the curve in the dynamic field of cell and gene therapies requires an ongoing investment in people, processes and technologies. To help ensure your cell and gene therapy programs continue to advance effectively and efficiently, Covance has formed strategic partnerships, made key acquisitions and invested in many impactful innovations to remain at the forefront of cell and gene therapy development.

Cell and gene therapies also require specialized therapeutic and specialty area expertise, in particular for rare diseases, pediatrics, oncology and immuno-oncology. Learn more about how we can mitigate risks, accelerate your development program and deliver precision medicine solutions Designed Around You®

Our Capabilities

Cell and gene therapies have already made a profound impact on patients’ lives and have the potential to impact many more. Whether you’re using CRISPR/cas9 for gene editing to develop a gene replacement therapy, engineering a CAR-T cell therapy or developing other innovative product types, you’ll benefit from our cross-functional capabilities that span early development to the clinic to commercialization and post-approval testing. 

Key Highlights:

  • Expertise in each phase and across the continuum
  • Coordinated capabilities from one partner
  • Focused investments in cell & gene therapy development
Enterprise Solutions
  • Preclinical, Clinical, Laboratory, Post-approval Solutions
  • Gene Therapies, Gene-modified Cell Therapies, Adoptive T-cell Therapies, etc.
  • Rare Diseases, Pediatrics, Oncology and Immuno-oncology
  • Scientific Strategy and Execution
  • Program Consultation and Management
  • Regulatory
  • Commercialization
  • Biomarkers and Companion Diagnostics

  • In vitro & in vivo Pharmacology & Toxicology
  • Bioanalysis: distribution, persistence & shedding
  • Biomarkers
  • Regulatory & Strategic Product Development Consulting
  • Clinical Development Preparation
  • CMC Analytical Testing
  • Commercialization Strategy

  • Clinical Studies, with focused expertise in Oncology, Rare Diseases & Pediatrics
  • Regulatory & Strategic Product Development Consulting
  • Biomarkers, including Companion Diagnostics
  • Central Labs
  • Bioanalysis: distribution, persistence & shedding
  • CMC Analytical Testing
  • Commercialization Strategy

  • Post-marketing Commitments, including long term follow-up
  • Real World Evidence
  • Pharmacovigilance
  • Patient Support and Call Centers
  • Regulatory & Strategic Product Development Consulting
  • Specialized Testing through LabCorp
  • CMC Analytical Testing