Disposables: Biopharmaceutical Disposables as a Disruptive Future Technology - Users and vendors convene at an IVT meeting on disposables to discuss the potential of single-use technology in bioproduc


Disposables: Biopharmaceutical Disposables as a Disruptive Future Technology
Users and vendors convene at an IVT meeting on disposables to discuss the potential of single-use technology in bioproduction over the next 10 years.

BioPharm International
Volume 20, Issue 6

Disposables May Allow Contract Manufacturers to Provide Unique Services

In five years, according to Vickers, we will see an increase in the number of boutique contract manufacturers. "Disposables will allow the establishment of contract start-ups," he says. "Many will flourish because lower capital expenditure is required and they will operate at scales that are optimal for disposable use. These CMOs may provide unique services, such as cytotoxics, because they will not have to worry about tank-to-tank changeover issues from dissimilar products, for example, changeover from baculovirus expression to protein expression in mammalian cells."

Disposables Use in Animal Health

Disposables are likely to be used more often in the manufacture of animal health products, i.e., those regulated by USDA, not FDA. As a result, here is the potential to lower the barrier of entry to the animal health industry. At present, this industry pours substantial capital into clean facilities, so a closed system may be very attractive. Today, disposable manufacturers do not seem to be concentrating their R&D or product development in animal health areas. This may represent a possible market for disposables.

Accelerated Production in Developing Countries for Export

According to Holly Haughney, vice president of marketing at Pall Life Sciences, Biopharmaceuticals Asia, "Validation of cleaning in biopharmaceutical manufacturing can require a considerable amount of work for the submission for a new drug to the FDA or EMEA. In developing markets, such as India and China, where it is necessary to meet these requirements of the US and European regulatory authorities if manufacturers expect to enter the lucrative export market, the use of disposable systems provides a benefit in the reduced amount of testing and documentation for cleaning validation." Some industry analysts point to the potential to limit expensive infrastructure as a way to move toward "transportable factories." Disposables may possibly support efforts in developing markets such as China, India, Korea, and Brazil. Initially, hybrid systems may make production there more practical, perhaps in 5–10 years. Disposables may also facilitate local production of biologics by reducing the staffing requirements for talented employees that can produce regulated products. A fully disposable-oriented facility could probably reduce headcount.

Vaccine Manufacturing

New viruses like avian influenza have increased the need for speed and safety in vaccine production. Disposable technologies can provide an advantage in these areas. For some products, according to Hélène Pora, PhD, marketing director of biopharmaceuticals at Pall Life Sciences, 70% of development and production time involves quality and safety controls. In vaccine production, potent microorganisms upstream in the process can present contamination risks and slow development. Disposables address these issues and can reduce the steps required to separate and purify conjugate vaccines. Disposable technologies can also be used in polishing steps where disposable membrane columns can remove contaminants more rapidly than resin-based chromatography can.

Improved Plant Safety

Disposable manufacturing technologies can provide plant safety benefits. According to Robert Blanck, market manager at Millipore Corporation, "Disposables in the future will improve safety. Some areas in which this is already occurring include new gamma pre-sterilized flow paths, reservoirs, storage containers, filters, and connecting devices being developed that improve plant safety by making sterile parts free of operator intervention. Separating the operator from the product improves operator safety. This may be particularly valuable to the manufacture of products such as cytotoxics."

Rapid Downstream Purification

New types of mixed-mode chromatography sorbents will make protein purification faster and cheaper. Chromatography is efficient and versatile and such products address downstream production bottlenecks caused by new technologies which have been adopted upstream in biopharmaceutical production. The ability to purify different kinds of molecules allows users to develop platform technologies that can reduce the number of process steps. Mixed-mode sorbents can distinguish proteins that have similar or close isoelectric points. The ability to adjust selectivity will provide for a wide range of applications, including monoclonals, vaccines, enzymes, and plasma fractions.

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