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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Custom CGMP Virus Manufacturing Platforms
Charles River has proprietary producer cell lines for both adherent and suspension HEK293 and 293T cell lines. We offer large-scale chromatography purification services (IEX, AEX, affinity, SEC, etc.) based on our clients’ preference, material needs, timeline, and long-term development plan.
| Custom Virus Manufacturing Project | Example Viruses | Application |
| Tropical Infections | Dengue, Ebola, etc. | Vaccine Studies |
| Sexually Transmitted Infections | HPV, HIV, etc. | Vaccine Studies |
| Gene Therapy | AAV, lentivirus, helper-dependent adenovirus, retrovirus, HSV, Poliovirus, VSV, etc. | Expression Vectors |
| Oncolytic Viruses | Adenovirus, HSV, Vaccinia, Reovirus, Measles, NDV, etc. | Cancer Therapeutics |
Vaccine Projects
Emerging infectious diseases have gained attention in recent years due to the number of outbreaks and their association with human neurological disorders. For many of these diseases, there are currently no approved therapies or vaccines. In addition, there remains a demand for new vaccines for old scourges such as influenza. At Charles River, we are passionate about our mission to help support scientists advance their biomedical research and, ultimately, to make vaccines affordable and accessible to those in need. To date, we have provided CGMP virus production services that have been used in the development of vaccines for infectious diseases including Dengue, HIV, and HPV. We know that there is no single CGMP virus production strategy that works best for all CGMP custom virus projects, so we offer the flexibility of multiple virus production platforms and the expert knowledge to help you decide which process will best meet your individual needs.
Gene Therapy Vectors and Oncolytic Viruses
We recognize that a great variety of gene therapy vectors exist, each with unique advantages and potential applications. As examples, vectors based on HSV, poxviruses, and helper-dependent “gutless” adenoviruses offer the potential for large payload capacities beyond what can be attained by AAV or lentiviral vectors. Some viruses have a natural tropism to certain target tissues (such as the neural tropism of poliovirus or HSV) that make them well-suited for certain disease applications. Oncolytic viruses have either a naturally occurring or engineered ability to selectively replicate in and destroy cancer cells and continue to show promise in pre-clinical and clinical studies, particularly in combination with immunomodulatory drugs. Regardless of which platform you need, we welcome the opportunity to provide custom gene therapy virus manufacturing services to advance your CGMP project.
Choosing a Virus Production Cell Line
Virus vaccine production may utilize cell lines that preferentially produce attenuated strains of virus. While Charles River has developed proprietary HEK293 and 293T producer cell lines for both adherent and suspension culture production methods, we also work with client-supplied cells for which we can provide CGMP master cell and virus banking services. Suspension cultures allow for the use of serum-free, chemically-defined media, which can allow for a more streamlined production of vectors intended for clinical use. In addition, suspension cultures can be grown to larger scales. We will guide your selection of cell line and culture condition based on the application of your virus and quantity of CGMP virus required.
Need to discuss your upcoming CGMP virus manufacturing needs? Contact us.
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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Frequently Asked Questions (FAQs) about CGMP Virus Production
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How long does it take to produce a custom virus?
Clinical-grade CGMP virus production involves many steps to ensure the quality and safety of the final product. The first step of any campaign is the process development phase, in which various parameters involving the source plasmids, producer cell lines, and purification methods are optimized. Following this step, procedures must be adapted to the larger scales required to generate the increased amounts of material required for clinical trials. Next, an engineering run is performed to confirm that all of the processes and procedures yield the expected amount of virus at the larger scale. After the engineering run, a CGMP run that fully complies with FDA and EMA guidelines is performed. This is the run that produces the actual material for clinical use. However, before this material can be used in patients, quality control testing must be conducted in order to confirm the final product’s identity and purity. Finally, release testing must also be completed before the final product is deemed ready for use in patients. The release testing confirms sterility and stability of the final product. Altogether, it can take 10-15 months to complete a CGMP project.
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Why include an engineering run?
The engineering run is a vital part of any CGMP virus manufacturing campaign as it allows for the detection of any unforeseen issues that could impact CGMP virus production. The engineering run uses the exact same procedure as the GMP run, but is not performed in the CGMP facility (i.e., no regulated air supply and not subject to QA oversight). This run allows for the confirmation that all of the campaign-specific processes will be successful and that the expected viral titer will be obtained. Material produced during the engineering run can be used for in vitro or in vivo testing (or toxicity studies) but cannot be used in patients.