Cell & Gene Therapy

Cell and gene therapy are innovative fields of medicine that aim to treat, prevent, or potentially cure diseases—especially those with genetic origins—by targeting the root causes at the cellular or genetic level.

Cell Therapy involves the transfer of specific cells into a patient to repair or replace damaged tissues or cells. These cells can be:

• Autologous (from the patient)
• Allogeneic (from a donor).

Gene Therapy focuses on modifying or replacing faulty genes within a patient’s cells. This can be done:

• In vivo (directly inside the body)
• Ex vivo (outside the body, then reintroduced)

Clinical trials for cell and gene therapies (CGTs) present a distinct set of challenges due to the complexity, novelty, and regulatory sensitivity of these advanced modalities. Versiti, the premier partner in clinical trial support is uniquely positioned to support research and further manufacturing for patients awaiting these innovative therapies.

Every CGT study of new treatments requires 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.

Starting Biomaterials:

We can provide a wide variety of blood products to advance your research. Our expertise in blood collection, apheresis procedures, and donor management ensures availability and production of the highest-quality, most well-characterized human blood products for research.

Starting Biomaterials:

We can provide a wide variety of blood products to advance your research. Our expertise in blood collection, apheresis procedures, and donor management ensures availability and production of the highest-quality, most well-characterized human blood products for research.

Cold Chain Logistics:

Cold chain logistics refers to the specialized transport, storage, and handling processes required to maintain temperature-sensitive biological products—such as cell and gene therapies—within a strictly controlled temperature range throughout the entire supply chain. Our expertise in sample logistics ensure accurate, timely handling of CGT samples.

Regulatory Expertise:

Our expertise in regulatory pathway guidance ensures that CGT investigational products meet the rigorous standards of health authorities across different regions. These processes utilize strategic planning, regulatory expertise, and precise documentation to facilitate timely approvals, maintain compliance, and enable the progression from concept to market.

Integrated Trial Management:

We provide end-to-end trial management services, such as kit design, sample handling, study design, protocol writing, and clinical data management. Our dedicated experts act as an extension of your team to provide recommendations to improve trial efficiency, provide scalable solutions to support trials of all sizes, and ensure your project is completed on time and within budget.