THE CLINICAL QUALITY YOU DEMAND. THE QUANTITIES YOU DESIRE.
When you’re ready to take your vector process out of the lab, and into a clinical trial, let Genezen be your partner for these crucial next steps.
Genezen works with the vector production facility at Indiana University, founded by Dr. Ken Cornetta. Additionally, Genezen has a master service agreement with the Cincinnati Children’s Hospital Medical Center, also a leader in viral vector technology. Because of these relationships, we can offer our clients access to both the research talent and the manufacturing capacity custom designed to meet the needs of early stage clinical trials.
We take regulatory compliance very seriously. All our team members receive regular HIPPA compliance training, using only anonymized data collection and reporting techniques. Our facilities are FDA and CLIA compliant and inspected regularly. Our production and distribution methods are cGMP certified, to ensure you will always have a clean and effective vector product, no matter whether your product is in storage or being shipped.
Vector Manufacturing Services:
• Foamy Virus
• Gamma Retrovirus
• Plasmid DNA
Manufacturing Process/Quality Control:
• 8 vector testing bays (correct?)
• ------- square feet of manufacturing space
• Qualified Person (QP) certification
• Aseptic fills
• cGMP certified manufacturing
• Master cell bank production
• Working cell bank production
• HIPPA compliant
• FDA compliant
• T-75 ml. Small Productions up to Larger Scale Pre-clinical Grade Quantities
• Certified Clean Room Manufacturing, Under Hood
• Chromatography and filtration systems for scalable purification
• Secure cell bank room with fully validated and monitored vapor phase LN2 storage
• Access to cGMP compliant master cell banks for common cell lines including HEK-293, WISL and MDCK
• Disposable/closed systems for virus harvest and concentration
• Established quality control methods including plaque/viral/titer, viral particle HPLC assays, host impurity assays (DNA, RNA, protein) and process impurities (ex. Benzonase)
For more information on our manufacturing services, contact us for a consultation.