When you work with Genezen, we streamline the process of contracting with academic institutions. Our team works with you from early vector design all the way through the production of a clinical grade vector. Come to us with your viral vector and testing needs and we will connect you with the dedicated experts to advance your project efficiently and ensure you are ready for regulatory scrutiny.
We manufacture your vectors in cGMP compliant manufacturing facilities using validated processes. Our cell manufacturing services include a wide variety of primary human cell types and can help you develop and scale up your ex-vivo gene transfer and cell therapy clinical trials. Additionally, we provide testing services in dedicated vector testing labs for your vector and clinical trial samples. All testing is QA reviewed and certificates of analysis are issued for your records.
We can work with you to develop a process with your gene of interest or adapt your current process for scaling up to GMP production. Genezen has valuable experience in viral vector production with specific expertise in lentivirus and retrovirus.
We take regulatory compliance very seriously. All our team members receive regular HIPAA 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.
Manufacturing Process and Quality Control
- Certified clean room manufacturing
- Chromatography and filtration systems for scalable purification
- Qualified Person (QP) certification
- Aseptic fills
- cGMP certified manufacturing
- Master cell bank production
- Working cell bank production
- FDA compliant
- T-75 ml small productions up to larger scale pre-clinical grade quantities
- HIPAA compliant
- 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 HEK293, 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)
TRANSDUCED CELL MANUFACTURING
Our cell manufacturing services include a wide variety of primary human cell types and can help you develop and scale up your ex-vivo gene transfer and cell therapy clinical trials. We can also transfer your at-scale technology to our cleanroom facilities to advance your research to clinical stage. Additionally, we offer more than minimally manipulated cell and tissue procedures performed aseptically in accordance with compliance requirements.
- Hematopoietic progenitors and stem cells
- T lymphocytes and other immune cells
- Embryonic and induced pluripotent stem cells
- Enrichment or depletion of specific subsets
- Genetic modification (transduction)
- Expansion, differentiation
- Product cryopreservation
- Cellular stability studies
- Thaw and preparation for infusion
Compliant with GMP (21 CFR 211), GTP (21 CFR 1271) and facility holds a Type V Master File (MF-BB) with the FDA.
- RCL Co-culture
- RCL by PCR
- GALV RCR
- Ecotropic RCR
- Direct RCR
- ADA Isoenzyme Analysis
- DNA Isolation
- Vector Insert Stability
- In-Vitro Viral Assay
- E1A qPCR
- SV40 qPCR
- Residual Benzonase
- Residual Human DNA
- Vector Copy Number by qPCR
For more information on our services, contact us at firstname.lastname@example.org or submit this form.
9900 Westpoint Dr, Suite 128
Indianapolis, IN 46256
Noyes Pavilion, Lab E536
1800 N. Capitol Ave.
Indianapolis, IN 46202