Thinking Inside the Box - Pharmaceutical Technology

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Thinking Inside the Box
A modular approach to biopharmaceutical production could bring process flexibility, and contract manufacturing organizations are beginning to take notice.

Pharmaceutical Technology
Volume 34, Issue 5, pp. 34-40

The future of modular manufacturing

Despite the advantages that they stand to gain, CMOs have not yet rushed to embrace modular manufacturing for several reasons. For one, single-use technology, a critical element of modular manufacturing, is still evolving. CMOs are not yet comfortable with these components because they don't believe that they are as robust as they should be. Most contract manufacturers are using disposable technologies for noncritical applications such as preparing buffers and media, but not for running critical unit operations, says Millipore's Krishnan. CMOs don't see these technologies as tried and tested, and many of them have not evaluated all the new disposable components.

In addition, modular manufacturing still is a relatively new strategy for the biopharmaceutical industry, and CMOs need to become familiar and comfortable with the technique. The modular approach is a change in mindset. CMOs already have invested in stainless-steel manufacturing equipment, and attitudes about what is possible and what is impossible with single-use technologies must change, says Krishnan.

SAFC (St. Louis) considered building a modular, multiproduct viral facility at its site in Carlsbad, California. Despite the technique's promise of flexibility and easy scale-up, SAFC finally decided to establish a stick-built facility. The company was uncertain about the long-term applicability of modular walls to a containment facility that needed complete segregation of products and air, said Dave Backer, SAFC's director of business development and marketing. Instead, SAFC incorporated modular sections in some of the facility's walls to enable the movement of large equipment. New systems probably have alleviated the company's original concerns, Backer acknowledges.

For the moment, limitations on available single-use technology force CMOs to decide whether to maximize flexibility at the expense of scale or vice versa, says Backer. But the landscape is changing. "Modular manufacturing will become more commonplace, particularly for early-phase clinical trials," says Backer. "The increased use of disposable bioreactors will most likely accelerate this process."

"We are seeing more and more CMOs talking to us with an intent to set up single-use manufacturing facilities," says Krishnan. "Certainly we are seeing the movement there, but I don't know if anybody has fully set up a facility like that yet."

The adoption of modular manufacturing is on the rise, and CMOs are starting to use modular approaches for new facilities and processes, says Pharmadule's Almhem. Preconceptions that modular manufacturing is expensive and inflexible are changing as more modular projects are completed and more companies embrace the concept.

Baxter recently began using modular processes at its Bloomington, Indiana, facility, says Trudeau.

CMOs that are pursuing modular manufacturing are now in the minority, but acceptance of the technique is growing. Some believe that the industry is on the brink of a paradigm shift. "In the not-too-distant future, most manufacturing processes and facilities will be built using modular concepts and technologies," says Almhem.

The slow adoption of modular manufacturing is not unusual because the industry traditionally has been reluctant to accept innovations and unfamiliar technologies. But observers believe that change is on the way. "Three years down the road, if CMOs are still building traditional facilities, that would certainly be a surprise to me," says Krishnan.


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