Are Single-Use Standards Stuck? And Is That a Bad Thing?

Efforts to enact meaningful standards for single-use bioprocessing technologies move at a snail's pace, with no clear path forward, experts say.

By Paul Thomas, Senior Editor

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At BIO 2012 in Boston this week, representatives of leading bioprocessing solution providers gathered to discuss the state of standardization of single-use products and materials. The panelists—Sartorius Stedim’s Paul Priebe, Pall’s Ian Sellick, EMD Millipore’s Richard Pearce, and ATMI’s Jeff Craig—were in agreement that the single-use community is lacking in meaningful standards, and that what standards do exist are, as Sellick put it, a “mishmash.”

But they also agreed on another thing: we must proceed with caution. Standards, applied carelessly or hastily, can squelch innovation. Given the plethora of exciting new disposable products in development and hitting the market, none of these suppliers want to apply the brakes. And while end users crave consistency and compatibility in single-use products, they also crave better and more products. So what to do?

Priebe, Director of Fluid Management Technologies for Sartorius Stedim Biotech, framed the discussion. “There’s a lot of demand for standardization,” he said, “but no agreement on what that actually means.”

We need to better define what we really mean by standardization—whether for materials, product types, testing and qualification methods, and so forth, Priebe said. End users have their ideas, suppliers have theirs. In terms of product categories, products from tubing to filters to bioreactors need standards as well, but not necessarily all at the same time or by the same standards-setting organizations.

“The important point is,” he said, “today no standards exist here. We may all use the same compendial standards—for example, USP <788>—but that’s a standard written for a drug product. It really doesn’t provide a platform for decisionmaking between suppliers.”

“And we can’t work on everything,” Priebe concluded. “Where do we work first?”

Too Many Cooks?

And who will do the work? There’s a lack of consensus as to which organizations are best suited to issue standards and should move forward with single-use standards, said Sellick, Pall Life Sciences’ director of marketing. Groups like ISPE, PDA, ASME, ISO, USP, and even FDA and ICH are mentioned in standards/guidelines discussions, and initiatives are moving ahead within these organizations. The BioProcess Systems Alliance (BPSA) has established some good guidelines on extractables and leachables, he noted, but what role should that organization play here on out?

“The organizations have to come to a consensus,” said Sellick. “There have been some meeting between these organizations, but there has to be more.”

Pearce, head of Business Strategy and Operations for Merck Millipore BioDevelopment (EMD Millipore), clarified the delicate situation that standards present. End users want manufacturing flexibility, reliable and robust processes, and product and process quality, he said. Standards clearly play a role towards these ends. Manufacturers desire standardization first within each facility, but also, increasingly, across global sites.

But for some single-use components and equipment, now is not the time to standardize, he said. Bioreactors present one example. “We shouldn’t look at standardizing them yet, because it’s going to stifle innovation,” he said. “You need to look at this balance between innovation and standardization. It’s also a matter of time and resources. If we spend all of our time on standardization, maybe we’ll miss opportunities for innovation.”

ATMI’s Craig, global director of Business Development and Marketing, drew comparisons between developments in single-use and those that have already taken place in the semiconductor industry (for which his company also provides solutions).

The bioprocess industry is about 10-15 years behind semiconductors in terms of standards development, he noted. “In more mature industries, standards are credited with reducing qualification and validation costs, and enabling growth to industrial and commercial scale,” he said.

An inceasing number of studies have shown that standards contribute to economic growth, Craig noted. But an industry must be ready for them. “The evolution of standards is fueled when multiple parties see the benefit,” he said, adding “some pain must be evident to coalesce the significant energy” needed.

“At the end of the day, standards are ultimately set by the end user,” Craig concluded. Thus, when the void or confusion becomes unbearable for biomanufacturers, better standards will emerge.

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