Thinking Inside the Box - Pharmaceutical Technology

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PharmTech Europe

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

What's in it for CMOs?

Disposable downstream equipment such as chromatography columns is being accepted and validated for commercial processes. PHOTO: COURTESY OF GE HEALTHCARE
CMOs are likely to benefit most from modular manufacturing, particularly when they use disposable components, says Mani Krishnan, director for Mobius single-use processing systems at Millipore (Billerica, MA). CMOs always must be ready to produce various molecules that require distinct processes, and they must be able to produce materials at various scales. A modular manufacturing facility can be reconfigured ra-pidly to meet the needs of the molecule. CMOs that use this approach thus can apply Lean strategies to respond quickly to particular customers' changing needs and change over between different customers' projects easily. This flexibility can help CMOs increase their output and reduce their costs.

Even before production begins, a modular approach can be beneficial because it simplifies validation. The CMO's burden is less to begin with because the equipment vendor has already started the validation work. Furthermore, a CMO can perform process validation more easily and with less work if it involves one unit operation at a time instead of two, three, or four connected together. The chances of demonstrating consistency by completing three perfect batches are greater for one operation than for many, says Galliher.

Modular manufacturing enhances a CMO's speed and flexibility in the production of modern vaccines, monoclonal antibodies, and novel biomolecules entering the clinic. A company can design a modular facility that accommodates various kinds of bioreactors (e.g. for mammalian cells or for bacteria) and manufactures at several scales. Disposable components make it possible to dedicate a modular facility to a single product (e.g., recombinant proteins, monoclonal antibodies, or vaccines) or to allow it to produce multiple products as required, says Grund.

If properly designed, a modular process could help a CMO to increase the number of contracts it can execute in one plant simultaneously. Ordinarily, a plant might have five or six unit operations in a row that are all dedicated to one client or to one cleanroom. But a CMO can install enclosed, modular unit operations to enable it to serve five clients in the same room, each in its own module. This arrangement would give a CMO five times the revenue with the same manufacturing group that it had before. "That gives us a huge multiplier on profits, margins, and revenue capability," says Galliher.

This approach works because the enclosed module becomes the cleanroom, and the module often can conserve valuable plant space. For example, the FlexFactory from Xcellerex has a footprint that is 35–40% smaller than a traditional cleanroom facility that includes gowning areas and access hallways, according to Galliher. The cost of a gray space with cleanroom modules is also lower than that of a conventional cleanroom.

On the other hand, the initial development costs for modular equipment often are higher than those for traditional machines, and this factor might prevent some companies from taking a modular approach, says Trudeau. Yet CMOs ultimately have a strong incentive for embracing the technique because it increases their speed to market, he adds.


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