Parrish M. Galliher, founder and CTO at Xcellerex, will explain how universal, rapidly deployed single-use products represent a paradigm shift for vaccine manufacturing. Disposables, Galliher says, are enabling vaccine makers to “avoid traditional bottlenecks impacting quality, cost, time, and first dose.” Moreover, the benefits are accessible to vaccine manufacturers operating in subunit, live/attenuated virus, or virus-like particles in microbial, mammalian, or insect cell cultures.
Vaccines and disposables fit naturally together, Galliher argues, because “vaccine manufacturing does not occur on a mega-scale” as, for example, therapeutic antibody processes. “Many vaccine facilities run at 1,000 to 2,000 liters, up to about 6,000 liters. So you could say that vaccine manufacture represents a sweet spot for single-use equipment.” This trend is assisted by the slow but inevitable switch to cell-based manufacturing processes.
Biotech’s mostly positive experiences with single-use cell culture processing is the basis, Galliher argues, for disposables’ application to cell-based vaccine production. Xcellerex’ current volume leader for bioprocessing is a 2,000 L bag, with a 5,000 L reactor expected to debut by the end of 2010.
Disposables are not as useful for egg-based influenza vaccine manufacturing, which still dominates world markets. This begs the question: considering the known logistical shortcomings of egg-based manufacturing, why has cell culture-based production been so slow to catch on? Galliher cites lack of adequate clinical experience, difficulties in running large human vaccine studies, the low cost of egg-based manufacturing, and the huge legacy investment in the older technology.
“There has been very little incentive to innovate,” Galliher explains. “But now, with greater public and governmental awareness of the potentially devastating impact of pandemic outbreaks, and with governments investing in cell-based vaccines, development will pick up.”
Galliher’s claim of a “sweet spot” for disposables in vaccine production is not mere boasting. His company has collaborated with Novavax on scaling its production process from several hundred liter disposable bags to 1,000 L disposable stirred-tank process.
In fact, at the meeting, Hua Jiang, Ph.D., senior manager for downstream purification at Novavax, will delve deeply into his company’s use of single-use vaccine production. Novavax made headlines two years ago with its idea of regional, flexible, quickly deployed single-use production of H1N1 influenza vaccine.
Later on in the program, Jean-François Chaubard, director of viral production at GlaxoSmithKline Biologicals, will describe his company’s efforts in upstream viral vaccine processing. Chaubard will focus on cost of goods and biosafety for a microcarrier-based process.
Selling the Idea
The maturation of single-use biomanufacturing has been accompanied by a more analytic, if not quantitative, approach to the question: “To dispose, or not to dispose?” Peter Latham, president of BioPharm Services will run a workshop at IBC that discusses drivers for and against implementation of single-use equipment.
It is often convenient to couch such discussions within the context of process-specific pros and cons—for example, the time spent on cleaning validation vs. the cost of single-use systems; the environmental impact of using and discarding all that plastic compared with the carbon footprint for creating thousands of gallons of ultrapure water; or for contract manufacturers, implementation costs vs. nimbleness, speed, and flexibility.
Latham suggests something perhaps as critical, namely “selling the concepts” of disposability internally, to colleagues and upper management.
“There’s a broader issue around convincing people to take a chance on anything that might be different or new,” Latham explains. “Even though this is less true for single-use technologies today, you still have to convince people. When you have a product with an 80 percent or 90 percent margin, you don’t want to risk your supply chain.
“That’s why it has taken years for single-use equipment to catch on, despite their obvious benefits. As margins go down and familiarity with single-use technologies increases, this internal sale is becoming easier every day.”