In the past, biopharmaceutical manufacturing was extremely CAPEX and OPEX intensive. The high gross margins and benefits achieved
with the produced drugs made it possible to neglect the COGS, because the main objective was securing drug supply. The objective
of future developments must, however, be the design of purification processes without chromatography steps, which will result
in a further simplification and significant reduction of the average CoGs for manufacturing of mAbs (9). Today, with the advent
of biosimilars, smaller market shares, and difficulties in finding new drugs, the biopharmaceutical industry — especially
in the developed world—faces difficult times that demand swift adaptation to increase productivity, maintain market share,
and remain competitive with new entrants from the East.
New technologies such as single-use components offer new ways to approach and resolve the challenges of the biopharmaceutical
industry and resolve the paradox between low cost and high quality.
The evolution and maturation of single-use technologies over the past two decades has now reached a scale feasible to support
Today, the entire manufacturing processes can be closed and isolated from the operator. To design efficient closed processes,
a holistic approach is required that integrates all unit operations from upstream processing through downstream processing
to the isolated drug substance.
This prerequisite marks a major paradigm shift within the biopharmaceutical industry as the manufacturing process becomes
for the first time the product, while in the past only end-product testing was applied, disregarding the manufacturing process
This holistic approach also prompts a review of the current manufacturing facility layout. The closing of the manufacturing
process allows the application of new facility concepts resolving the paradox between regulatory requirements for segregation
and process simplification.
Modular facility concepts allow manufacturing facilities to be built even faster and at lower CAPEX costs. The new concepts
also make qualification, validation, maintenance, and operation simpler, lowering the OPEX further.
Today's new technologies and concepts resolve the paradox between low cost and high quality in biopharmaceutical manufacturing.
The key is to think in a holistic way, to be bold, and to translate the new regulatory requirements such as QbD and PAT into
new operating models that are sustainable in the future competitive environment (11, 12). Taken together, new technologies
based on disposability continue to redraw the economic landscapes of biopharmaceutical companies. An assessment of the fullest
value of these technologies requires the broader context of the variables of facility design, QbD, and risk assessments as
outlined in ICH Q8/9/10 [8-10], and the established pathways of lead development in order to capture all the benefits stemming
from these new technologies (10).
PARRISH GALLIHER is founder and chief technology officer of Xcellerex, a GE Healthcare Life Sciences company, Marlborough, MA, Parrish.Galliher@ge.com
ALAIN PRALONG* is vice-president of New Product Introduction & Technical Life Cycle Management, GlaxoSmithKline Vaccines Wavre, Belgium,