Cell & Gene Therapy

Cell & Gene Therapy
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Combining Research and Novel Diagnostic Testing to Advance Cell and Gene Therapy Trials

Cell and gene therapies (CAGT) hold transformative potential for treating diseases that have been historically resistant to traditional medical approaches. Every CAGT study of new treatments presents a unique set of challenges that require an individualized, specialized approach. Our multi-disciplinary team provides expert guidance and support in navigating the clinical, regulatory and manufacturing challenges of your CAGT study to ensure its success.

 

We focus on:

  • Starting material for research or further manufacturing: Versiti specializes in sourcing high-quality, well characterized blood products critical for a wide variety of research and therapeutic applications.
  • Supporting regulatory strategy: Navigating the regulatory landscape in the development of cell and gene therapies can be daunting. Versiti's experienced team offers guidance in meeting regulatory requirements, streamlining submission processes, and ensuring consistent quality.
  • Driving clinical trial efficiency: Versiti’s central laboratory simplifies logistics and data integration in clinical trials to accelerate the development of life-saving treatments.

Our commitment to advancing science and improving patient outcomes ensures that your clinical trial is not just successful, but transformative for the future of medicine.

Versiti Blood Research Institute, Versiti Diagnostic Labs and Versiti Clinical Trial Services propel cell and gene therapy advancements by harnessing the power of blood research and novel diagnostic testing, aiding in disease discovery, treatment plans and patient care. For more than 75 years, Versiti has been a leader in blood health innovation, making us uniquely positioned to guide successful cell and gene therapy development.

 
Companion Diagnostic Testing
Versiti Diagnostic Labs’ development and testing services of companion diagnostics for therapeutic development.
 
Regulatory Strategy & Pathway Mapping
Versiti Clinical Trial Services delivers expert regulatory strategies and global filings to accelerate product approvals. Trusted guidance for life sciences and medical innovations.
 
Leukapheresis Products
Versiti’s peripheral blood mononuclear cell (PBMC) product is an enriched, fresh leukapheresis product composed of high concentrations of monocytes and lymphocytes, but may also contain lower concentrations of platelets, plasma and red cells.