Manufacturing synthetic immunotherapies

Inovio’s synthetic DNA immunotherapies consist of DNA plasmids encoded to produce one or more antigens associated with a target pathogen (e.g. bacteria, virus or cancer). As a carrier of genetic code, these DNA plasmids, which are circular pieces of DNA, have the advantage of being very rapidly designed and formulated. They are water soluble, meaning they can be formulated in physiologically relevant conditions. Additionally, after the plasmid delivers the DNA instructions into cells (assisted by Inovio’s proprietary electroporation delivery technology) they are readily metabolized by the body so that concerns about long-term persistence of the DNA plasmids are minimized. Numerous human clinical studies have established that DNA plasmids have a favorable safety profile.

Inovio’s DNA Plasmid Production DNA plasmids are produced using well-proven manufacturing techniques, including E.coli-based (bacterial) fermentation, alkaline lysis, membrane/column chromatography and tangential flow filtration. This production method has advantages over conventional vaccine manufacturing methods and other DNA vaccine carriers such as viral vectors (which are typically produced in mammalian cell culture) in terms of ease of implementation, reproducibility, scalability and cost-effectiveness.

Inovio’s DNA immunotherapy plasmids are produced by Texas-based VGXI, Inc. VGXI produces cGMP-grade plasmid products that have passed rigorous international regulatory reviews and have been used in numerous human clinical trials in the U.S., Europe and Asia. The proprietary process is covered under international patents to enable the production of high quality DNA plasmid products at high concentration. The process allows for final product concentrations up to 15 mg/mL, giving Inovio the ability to maximize the amount of immunotherapy per injected dose and also facilitates the formulation of multi-component DNA immunotherapies.

VGXI, Inc. is a wholly-owned subsidiary of VGX International, a Korea-based publicly traded company. Inovio owns a minority share position in VGX International.

Engineering and manufacturing electroporation delivery devices

Inovio’s engineering department is developing the next generation of devices with new features, lower cost, and enhanced usability and maintains the devices used in clinical trials. The company uses both internal and external resources to complete development programs.

Inovio maintains a California licensed Device Manufacturing Facility which is ISO 13485 and MDD certified by TÜV America in San Diego. Devices and consumables are both produced at this facility and by OEM suppliers. Clinical trials are supported through device testing and distribution at this location.

Inovio Pharmaceuticals complies with the following regulatory standards:

  • ISO 13485:2003/EN/ISO 13485:2012 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
  • ISO 14971:2009/EN ISO 14971:2012 Medical Devices – Application of Risk Management to Medical Devices

Inovio Pharmaceuticals holds the following device manufacturer’s license:

  • State of California - Department of Public Health – Food and Drug Branch Device Manufacturing License: 72311