Disposable modules
Figure 2: Selection guide for convective media, such as membrane adsorbers. HIC is hydrophobic interaction chromatography.
STIC is salt tolerant interaction chromatography. (ALL FIGURES ARE COURTESY OF THE AUTHORS)
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The flexibility of disposable modules is arguably the most important benefit in the context of the whole process, and this
reflects the broad industry perspective that manufacturing flexibility is now perhaps at least as important as capacity considering
the large numbers of products in clinical development. Process development can be streamlined and expedited because different
modules can be tested in various combinations to arrive quickly at the best overall set of process options, and the absence
of cleaning and validation requirements can shorten the time required to develop a finalized process by months or years. The
ability to replace each module completely also makes it easier to assemble process trains for new products in existing premises
without cross-contamination. The flexibility is most noticeable during scale-up because disposable devices are generally modular
and available in various sizes, and scaling up simply involves swapping one module for another with a higher capacity. It
is thus apparent that membrane devices can be scaled up with none of the attendant disadvantages of column resins, thereby
making the goal of polishing 100-kg batches of antibody entirely possible without oversizing.
LOOKING AHEAD
Innovations that take into account the current state of the industry as well as potential challenges and demands are likely
to be the most successful in the long term. At the same time, technologies borrowed from the edge of research always come
with risks that must be evaluated by manufacturers looking at major investments into capacity. The perceived bottleneck in
downstream processing can be addressed with lower-risk approaches, such as streamlining current production processes, with
moderate-risk approaches, such as introducing technologies that have already proven suitable in other industry settings, or
with higher-risk approaches involving the incorporation of novel technologies.
In several cases, these novel technologies have already proven their credentials in several processes and companies following
the paths set by the first adopters, the trailblazers of the industry, can be assured that the technologies involved now have
established their credibility.
The future of biomanufacturing is likely to rely more on innovation and flexibility than on traditional strengths, such as
large facilities and the financial muscle to invest in them. Disposable manufacturing is likely to play an increasingly important
role as companies maneuver in a crowded market to protect their R&D investments while more and more generics become available.
The ability to scale up or down quickly, to switch to new campaigns rapidly and to produce multiple products in the same facility
will be a key metric of success. Ultimately, the future of bioprocessing will require industry players to embrace the need
to change.
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