Gene and Virus Therapy - Viral Vector Production Laboratory Services

GMP Manufacturing, Large-scale Production and Purification, and Quality Control Assays

• Apply and/or develop viral vector manufacturing processes for new viral vector products to significantly increase the scale of virus production and purity of the viral product
• Develop appropriate quality control assays to characterize the viral product
• Use the developed manufacturing process and quality control assays to produce and characterize large-scale viral vector preparations for advanced efficacy studies and/or toxicology / pharmacology studies
• Operate and maintain a small but versatile Good Manufacturing Practices (GMP) manufacturing facility
• Convert a viral vector manufacturing process to conform to GMP
• GMP production and storage of master cell banks, master virus banks and the final clinical viral products
• Coordinate all of the clinical product safety testing required for release of the product to the clinic
• Obtain/prepare and archive all of the required GMP documentation of the product manufacturing process, product safety testing, GMP facility testing, and personnel training
• Provide all appropriate descriptions of the manufacturing process, product safety testing, and facility design and operation as well as participate in all formal reviews of this information to obtain approvals from all internal and external governing and regulatory bodies