GI Partners Acquires CDMO and Cell Solutions
As Rose BioSolutions, the established CDMO and Cell Solutions businesses continue to support the biotechnology ecosystem with cell sourcing capabilities and CDMO services to accelerate your advanced therapy from development to delivery.
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Streamline your Gene Therapy with Viral Vector CDMO Solutions
With various production strategies available, it can be difficult to choose the one that best suits your GMP viral vector manufacturing program. As an established viral vector contract development and manufacturing organization (CDMO), our viral vector center of excellence offers the flexibility of multiple manufacturing platforms and frameworks, integrated plasmid production capabilities, and the know-how built over decades supporting advanced therapy programs. From off-the-shelf research products and packaging services through custom GMP viral vector manufacture, our team can support you from concept to cure.
With the experience and dedication to quality required to scale up your viral vector gene therapy project into a patient-ready product, explore our range of viral vector production capabilities:
- GMP AAV Production
- GMP Adenovirus Production
- GMP Lentivirus Production
- GMP Retrovirus Production
- Custom GMP Virus Production
Ready to discuss an upcoming viral vector manufacturing program?
Employ Viral Vector Manufacturing Platforms to Cut Timelines in Half
With key benefits to gene therapy developers including reduced time to clinic, experience, and predictability, the Lentivation™ lentiviral vector and nAAVigation® adeno-associated viral (AAV) vector production platforms are designed to streamline and secure your clinical or commercial supply.
Simplifying supply chains by integrating the three pillars of phase-appropriate plasmid DNA manufacturing, viral vector production, and in-house testing, our established platforms enable a cost-effective and reliable path to GMP in less than seven or eight months, respectively, reducing production timelines by up to 60% compared to traditional manufacturing workflows.
Expedited development and 100% in-house analytics
Differentiated concept to cure CDMO and integrated testing powerhouse
Cost-effective, reliable path to GMP, clinic, and beyond
Need to reliably tech transfer an existing viral vector program? Explore Modular and Fast Track tech transfer frameworks
Explore our Viral Vector CDMO Facility
Specializing in GMP-compliant production of adeno-associated virus (AAV), lentivirus, adenovirus, and retrovirus for gene and gene-modified cell therapies.
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Viral Vector Production Process
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Cloning and Construct Evaluation
With extensive experience in the design and cloning of gene therapy vectors, we have a comprehensive toolbox including promoters, cDNAs, and reporter genes, and can help design custom constructs as required. Use our in-house AAV backbone, off-the-shelf Rep/Cap and Helper plasmids, or we can use yours. The team is well versed in troubleshooting challenging sequences.
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Upstream Production
We adopt a fully single-use upstream production process using our robust platform in adherent HEK293T cells.
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Downstream Purification
Vector material is harvested, clarified, and (depending on the scale) purified by ultracentrifugation or affinity chromatography and ultracentrifugation using fully single-use materials. The platform process couples high recovery with high purity.
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Aseptic Fill Finish
Several aliquot sizes are available, depending on batch size, to suit your application.
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In-House Analytics
In addition to providing genome titer determination, as a market leader in analytics, we offer a range of optional QC tests such as endotoxin, bioburden/sterility, and SDS-PAGE.
Insights to Support your CGT Program
Optimize your viral vector manufacturing strategy with case studies covering the transition from adherent to suspension culture, the "QC Tax", and EU vs. US regulatory standards.
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From Concept to Cure
Cell and gene therapies have the potential to transform patient care by providing life-changing treatments for genetic illnesses. Our viral vector CDMO team offers end-to-end workflows from early discovery including viral vector research products and services through GMP manufacturing to commercial scale. We work with you every step of the way to ensure your therapeutic meets the highest standards of quality, regulatory compliance, and safety.
Frequently Asked Questions (FAQs) About Viral Vector Manufacturing
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What is the time frame for generating clinical-grade viral vectors?
The production of clinical-grade viral vectors can traditionally take 10-15 months to complete, as there are many steps involved in the process to ensure the quality and safety of the final product.
Charles River’s established nAAVigation® (AAV) and Lentivation™ (LVV) production platforms have the capability to cut a viral vector gene therapy program timeline to GMP by more than half versus traditional process development, translating to fewer than eight months for AAV and seven months for lentiviral vector.
The first stage of any campaign is process developbment, in which various parameters involving the source plasmids, producer cell lines, and purification methods are optimized and then scaled up to generate the increased amounts of material required for clinical trials.
Production Stage Purpose Process Development Services Upstream Optimization of parameters for scale-up and production, including culture and transfection conditions - Process optimization using scale-down models (T-flask, shake flask, 10L stir tank reactor)
- Cell growth optimization
- Media/feed screening and optimization
- Transfection/infection optimization
- High-density cell culture and transfection/infection
- Harvest, lysis, and clarification
Downstream Optimization of product recovery, purification, and formulation procedures - Column and membrane chromatography (affinity, ion exchange, size exclusion, mixed-mode, automated chromatography platforms)
- Bioprocess filtration (tangential flow, hollow fiber, depth filtration)
- Ultracentrifugation
GMP QC Services Ensures safety, potency, purity, and identity of final GMP drug product - Formulation studies
- Vial compatibility studies
- Viral clearance studies
- Viral stability studies
- Long-term stability studies
- Assay development
Once the scale up is complete a series of runs are performed to determine if the process and procedures yield the expected amount of virus and if the runs comply with regulatory guidelines. Quality control testing is conducted during this time to confirm the final product’s identity and purity, and finally, sterility and stability testing are performed to determine if the final product is deemed ready for use in patients.
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How to choose a viral vector production platform?
Many factors affect the decision of what type of viral vector to use in your experiment. Some considerations include how well the virus infects target cells, whether it integrates into the host genome, what size insert it can accommodate, and whether it will elicit an immune response. Our viral vector CDMO experts have the know-how to help you decide which platform is right for your specific needs. Speak with the team to explore your needs and to start your viral vector manufacturing journey.
Get your copy of our Viral Delivery Guide and choose the right viral vector for your research.