Gene Therapy

Gene Therapy

Gene therapy can cure disease by replacing a faulty gene or adding a new gene in body's cell of patient. However, there is some potential risks of this technique such as unwanted immune reaction, targeting the wrong cells, infection caused by the virus and the possibility of causing a tumor. So it is critical to perform detailed preclinical and clinical trials even though it can take many years. CD BioSciences is dedicated to providing tailored clinical studies depending on the characteristics of clients' product to speed up its availability.

Explore Our Clinical Services to Facilitate Your Gene Therapy Program

CD BioSciences is specialized in the design, execution and delivery clinical studies with a focus on gene therapy. We provide adequate studies to assess the feasibility and risks of the gene therapy products. The detailed clinical studies include:

• Pharmacokinetic studies include shedding studies addressing the excretion of gene therapy material products, biodistribution studies and pharmacokinetic studies of the transgene product.
• Pharmacodynamic studies address the expression and function of the gene expression product.
• Immunogenicity studies evaluate immune response to the transgene product.
• Efficacy studies demonstrate efficacy in the target population to evaluate the duration of the therapeutic effect.
• Clinical safety studies focus on the Infusion-related reactions and cytokine release, infection and inflammatory responses, immune mediated adverse effects, over-expression of the transgene, risk of tumour development and any unintended transduction of tissues.
• End-to-end, entire clinical trial development solutions including bioanalytical lab testing, clinical pharmacology, early phase clinical trials, late phase clinical trials, clinical data management, analysis and reporting, regulatory submissions etc.  

Moreover, by collecting and analyzing insights from patients and their families, disease communities and advocates, CD BioSciences provides long term monitoring of patients who have been treated with a gene therapy and gives long term efficacy and safety follow up.

Our Highlights

• Our configurable workflows with high flexibility can satisfy the unique requirements of your gene therapy product.
• Our highly trained experts with rich experience in gene therapy studies work collaboratively with our clients to finish the clinical trials.

CD BioSciences is dedicated to providing tailored services to help our clients overcome the difficulties in the clinical trials and speed up the gene therapy development process. If you want to get more information about our service, please feel free to contact us to discuss how can we move us forward together on the journey of getting your gene therapy product to market.