PharmaView: Single-Use Standards: What’s the Rush?

Aug. 6, 2012
Can standardization and innovation coexist?

Increasingly in our industry, “subject matter experts” are found within the vendor community. Many of pharma’s best and brightest have retired or been laid off, while other SME’s enjoy developing technological advances (rather than waiting, in the end user community, for them to appear). One area where vendors hold a monopoly on SME’s is in single-use technologies.

A collection of these smart folks in single-use met at BIO 2012 in Boston earlier this summer. Panelists on a forum, they included Sartorius Stedim’s Paul Priebe, Pall’s Ian Sellick, EMD Millipore’s Richard Pearce, and ATMI’s Jeff Craig. The topic of the day was standards.

Despite the collective brainpower, there were few good ideas on what to do in developing better standards for single-use. About the only consensus reached was that we lack meaningful standards, and that what standards do exist are, as Sellick put it, a “mishmash.”

The panel 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 solution providers 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?

We need to better define what we really mean by standardization—whether for materials, product types, testing and qualification methods, and so forth, said Priebe, Sartorius’ director of Fluid Management Technologies. 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.

“We need standards, but we can’t work on everything,” Priebe concluded. “Where do we work first?”

We don’t really know 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, 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.

But for some single-use components, now is not the time to standardize, he said. Bioreactors provide one example. “We shouldn’t look at standardizing them yet, because it’s going to stifle innovation,” he said. “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. 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.

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.

“Standards are ultimately set by the end user,” Craig concluded. Thus, when the standardization void becomes unbearable for biomanufacturers, improved standards will necessarily emerge.

About the Author

Paul Thomas | Senior Editor