Clinical Wing

Laboratory Director: Angelique Camp

Clinical-Grade Manufacturing and Testing Services

Clinical-grade products are manufactured in a 1200 sq. ft. facility that consists of four Class 10,000 production suites, a central equipment and storage hallway and office space.  The facility operates in full compliance with the cGMP regulations for Phase I studies for serious and life threatening diseases.  Compliance with cGMP is maintained through a comprehensive set of Standard Operating Procedures and the use of several Quality Control Systems.
 
Safety and sterility testing are performed at full cGLP at established contract testing labs.  All testing protocols are reviewed prior to testing and all test results are reviewed by the JVL Director and Quality Assurance.  Purity and potency testing is performed in dedicated space at the JVL using a sliding-scale approach to the cGLP requirements similar to that employed for cGMP regulations.

Clinical-Grade Platforms Available

• AAV (Serotypes 1-8)
• Adenovirus
• cGMP Plasmids
• Cell-based products

Scheduling and Pricing

• Clinical vectors are povided at cost to academic or non-profit organizations
• Pricing is based on pilot lots to establish vector yield
• Productions are scheduled according to established procedures
• Scheduling should be done as ealy as possible to avoid delays 

Other Services

• Help with preparing Pre-IND and IND packages
• Preparation of CMC data packages
• Coordinating the submission of
• Help with developing product-specific assays
• Help with RAC, IRB, and IBC submissions