Viral Vector Production
RVV & LVV: Safety & Scalability for Optimal Efficiency
Crafting retroviral viral vectors (RVV & LVV) for advancements in cell and gene therapy research, development, and clinical trials demands meticulously orchestrated and efficient procedures. A strategic CDMO collaborator is pivotal to guaranteeing product integrity, scalable production, stringent quality assurance, adept risk management, and unwavering regulatory compliance.
Look no further than the Roswell Park GMP Engineering & Cell (GEM) Manufacturing Facility. With decades of expertise in cell and gene therapy research, we stand as the preferred choice. Explore how our seamless viral vector production integrates seamlessly with on-site cell manufacturing, offering direct delivery solutions for clinical trial participants. Choose excellence with Roswell Park for your needs in the dynamic field of cell and gene therapy.
Opting for Roswell Park's GEM Facility as your CDMO partner guarantees unwavering consistency, stability, and purity in each viral vector production cycle.
Experience & Vigilance in RVV Safety
Safety is of the utmost importance in creating retroviral vectors – especially when scaling up GMP-grade products for Phase 1 and 2 clinical trials. The Vector Development & Production team at Roswell Park collaborates closely with you to assess your project requirements and establish a custom cGMP production plan.
Our single-use technology, closed process platform, and rigorous quality control protect the integrity and purity of your vectors. Comprehensive analytical assays confirm the required standards at every key step. It is a delicate balance of consistency and capacity — and Roswell Park has the decades of expertise needed to identify every opportunity for optimal efficiency.
Established RVV Production Process
- Establishing a master cell bank (MCB)
- Master cell bank certification
- Manufacture of cGMP retroviral vector supernatant
- Vector supernatant harvest and filtration
- Vialing and storage
- Certification of final product
Optimized LVV Scalability & Reproducibility
Roswell Park's LVV production facility adheres to current good manufacturing practices (cGMP), crafting compounds that align with precise criteria for identity, strength, quality, and purity. This guarantees that the resultant viral vector product meets the necessary standards for Phase 1 and 2 clinical trials and complies with the stringent regulations outlined by the Food and Drug Administration (FDA) guidelines.
Rely on our well-established protocols that craft suspension technologies for maximum stability and reproducibility. Throughout the process, we implement thorough analytical cell line testing and frequent assays customized to meet your specifications.
Established Transient Transfection RVV and LVV Manufacturing Process
- Cell plating of certified cells
- Transfection
- Transfection media removal
- Vector supernatant harvest
- Purification and concentration
- Vialing and storage
- Certification of final product
Notable Publications
McGray AJR, et al. BiTE secretion by adoptively transferred stem-like T cells improves FRα+ ovarian cancer control. J Immunother Cancer. 2023 Jun;11(6):e006863. doi: 10.1136/jitc-2023-006863.