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.