Viral Vector Manufacturing Services

The path to clinic for cell and gene therapies is complex, challenging, and time consuming. Offering expert guidance, established production platforms with industry leading timelines, unmatched quality, and operational excellence, our team works hand in hand with therapeutic developers to streamline and simplify viral vector programs. As a CDMO partner you can trust, allow our viral vector manufacturing experts to help you achieve a seamless transition from clinic to commercialization.

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Streamline your Gene Therapy with Viral Vector CDMO Solutions

Employ Viral Vector Manufacturing Platforms to Cut Timelines in Half

Viral Vector Production Process

From Clinic to Commercialization

Viral Vector CDMO Center of Excellence | Rockville, MD

FAQ’s

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 your drug development journey.

With the experience and dedication to quality required to scale up your viral vector gene therapy project into a patient-ready product, we offer a 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?

talk to the team

"Given the limited investment for rare disease groups like ours, FOXG1 Research Foundation has created a model that allows us and other patient advocacy groups to operate like a virtual biotech company; independently and efficiently driving drug development. The success of this model hinges upon operating as a highly efficient team while also partnering with organizations that are equally passionate about bringing treatments to children with the highest unmet need and significant burden of disease. Selecting the right partner is critical, and Rose BioSolutions (previously Charles River's CDMO division) has demonstrated a deep understanding of our model and shared commitment to advancing our therapies to clinic, and beyond."-

Nasha Fitter, Co-Founder & CEO, FOXG1 Research Foundation

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.

Speed

Expedited development and in-house analytics

Track Record

Differentiated concept to cure CDMO and integrated testing powerhouse

Predictability

Cost-effective, reliable path to GMP, clinic, and beyond

Need to reliably tech transfer an existing viral vector program? We offer Modular and Fast Track tech transfer frameworks to support any phase of the development pathway.

Viral Vector Production Process

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.

Upstream Production

We adopt a fully single-use upstream production process using our robust platform in adherent HEK293T cells.

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.

Aseptic Fill Finish

Several aliquot sizes are available, depending on batch size, to suit your application.

In-House Analytics

In addition to providing genome titer determination, we offer a range of optional QC tests such as endotoxin, bioburden, and SDS-PAGE.

From Clinic to Commercialization

Cell and gene therapies have the potential to transform patient care by providing life-changing treatments for genetic illnesses. Our integrated plasmid and viral vector CDMO team offers end-to-end workflows from research 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.

Up to 60%

viral vector production timeline reduction vs traditional workflows

30 Years

of viral vector research, development and manufacturing experience

Expedite your program

Viral Vector CDMO Center of Excellence | Rockville, MD

Leverage a dedicated viral vector manufacturing facility:

Established Contract Development and Manufacturing Organization (CDMO) founded in 2012 (previously Vigene Biosciences)

Operates in compliance with the following regulatory agencies or accredited organizations:

Good Manufacturing Practice (GMP)

Food and Drug Administration (FDA), USA

European Medicines Agency (EMA)

Research Court CDMO Facility: 50,000+ square feet/4,600+ square meters

Located in the Baltimore/Washington DC metropolitan area, one of the nation’s largest biotechnology clusters, in close proximity to Washington DC, National Institutes of Health (NIH)

Eight production suites including four GMP viral vector suites and a dedicated cell banking suite (adherent and suspension)

130+ employees

Frequently Asked Questions (FAQs) About Viral Vector Manufacturing

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.

The 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 development, 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.

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.

Tell us about your program

Tell us about your program. Whether you need human immune and stem cell products or CDMO services that include process development, clinical manufacturing, or preparing for commercial scale, we are here to support you. Send us a message describing what you need, and we’ll connect you with the right team.

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