December 6, 2013

Bioprocessing Advances in Vaccine Manufacture

Currently, SUS bioreactors top out at 2000 L, with many engineering challenges (e.g., weight) when larger. Where this does not provide sufficient manufacturing capacity, multiple parallel SUS process lines can be implemented. With advancing SUS technology, better plastics and new designs are being developed using SUS (vs. stainless steel) for their application in precommercial R&D, clinical-trial-material supply, and commercial manufacture. This use of SUS is projected to result in the market (primarily US and EU) for SUS equipment at a commercial scale growing 1000% in five years to $1.5 billion/year (2).

Going Modular
Going modular is the next advancement in bioprocessing hardware. It is closely related to the adoption of SUS technologies and involves housing SUS bioprocessing equipment within their own cleanroom cabinets—whether portable prefabricated trailers or equipment sealed within dedicated isolator cabinets—with these increasingly designed for plug-and-play simplicity. Bioprocessing facilities that formerly required years for planning and construction can be brought on line in a matter of months or even weeks. SUS have become common in less than a decade, in as short as 5 or 10 years; however, we may comparably be talking about industry widespread adoption of flexible bioprocessing modules and plug-and-play factories. Vaccines are expected to be one of the first product sectors affected by this trend. Modular technology will accelerate worldwide proliferation of vaccine manufacturing, including transfer of bioprocessing to lesser-developed countries. Even easier than with SUS process lines, modular systems allow whole plants to be essentially cloned, potentially allowing cGMP manufacture in many developing countries. Many foreign countries are and can be expected to demand local vaccine manufacture, particularly once modular facilities become commonplace, and equipment vendors plan to actively pursue this market.

Companies developing modular systems for vaccine manufacture include G-Con, which is working with partners, including Sartorius Stedim Biotech and GE/Xcellerex. For example, Project GreenVax, a private–public consortium, is currently constructing an influenza vaccine manufacturing facility (to be operated by G-Con, developer of the modular units being used) in Texas for manufacture of recombinant tobacco plant-expressed influenza vaccines, with a projected final scale capacity of 100 million doses per month [1.2 billion doses/year], according to company projections and production costs of pennies/dose compared with conventional dollars/dose for conventional egg-culture manufacturing. The Project Greenvax influenza vaccine-manufacturing facility, subsidized by biodefense funding, uses single-use equipment, housed within plug-and-play-type modular trailers, using tobacco plant expression technology. Medicago and other companies are also developing vaccines using tobacco-plant expression.


Tags: biosimilar; Asia; vaccines; plasma derived; bioprocessing development; vaccine manufacturing; single-use; bioreactors; analysis;