Gene Therapy

The replacement of a person's faulty genetic material with normal genetic material, known as gene therapy, may offer innovative solutions to treat or cure a disease or abnormal medical condition. A significant safety concern is the potential presence of Replication Competent Retrovirus (RCR) and Replication Competent Adenovirus (RCA) in retroviral or adenoviral vector-based gene therapy products, respectively.

RCR and RCA may develop at any step during the manufacturing process of gene therapy products. To ensure the safety of these therapies, the FDA has issued guidelines that encompass:

• Cell Line Development
• Cell Banking Services
• Cell Storage Services
• Cell Line Characterization
• Release Testing

Charles River’s Gene Therapy Program will help you accelerate your efforts to assure product safety and to meet FDA, ICH, and CPMP guidelines.

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