GMP Adenovirus Vector Production

Standardized processes and partnerships with global providers facilitate standardized BOMs, meaning raw materials are on hand on Day 0.

Our ability to produce phase-appropriate plasmid DNA, master cell banks, and master virus banks all in-house enables us to streamline your adenoviral vector program.

With proprietary HEK293 and 293T production cell lines for adherent or suspension culture and the flexibility to work with a cell line of your choice, we offer large-scale purification services based on our clients' preference, material needs, timeline, and long-term development plan.

Our platform approach to vector manufacturing provides adenoviral vector gene therapy developers an expedited, cost-effective, and predictive pathway to GMP manufacturing, relying on proven cell lines, extensive development and manufacturing experience, and templated documentation.

Analytical method development and testing capabilities with a range of pre-qualified platform assays, well-versed assay tech-transfer capabilities, and industry-leading assay development services.

Clinical-grade adenovirus production involves many steps to ensure the quality and safety of the final product. Altogether, it can take 10-15 months to complete a GMP project however this timeline can be significantly shortened if a manufacturing process has already been developed and/or if an engineering run is not required.

The Adenovirus Manufacturing Process:

1. The first step of any campaign is the process development phase, in which various parameters involving the source plasmids, production cell lines, and purification methods are optimized.
2. Following this step, procedures must be adapted to the larger scales required to generate the increased amounts of material required for clinical trials.
3. Next, an engineering run is often performed to confirm that the processes and procedures yield the expected amount of virus at the larger scale.
4. After the engineering run, a GMP 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 to confirm the final product’s identity and purity.
5. Finally, release testing must also be completed before the final product is deemed ready for use in patients. This confirms sterility and stability of the final product.

The engineering run is an important part of any GMP adenovirus manufacturing process as it allows for the detection of any unforeseen issues that could impact CGMP production. The engineering run uses the exact same procedure as the GMP run but is not performed under full GMP conditions (i.e., 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.

Because viral vector titer is highly sensitive to the size of the viral genome, the resulting viral vector manufacturing yield will vary depending on the size of the desired insert, the production cell line, and the purification method. Please contact us for more information about what yield may be obtainable with your insert.

For all of our adenovirus production services, we use non-pathogenic, replication-incompetent (E1/E3 genes deleted) human adenovirus type 5 (Ad5). Adenoviral vectors have been used in clinical trials for many years.