When the Process Becomes the Product: Single-Use Technology and the Next Biomanufacturing Paradigm - The move to single-use manufacturing has prompted a paradigm shift in facility design. - BioPharm


When the Process Becomes the Product: Single-Use Technology and the Next Biomanufacturing Paradigm
The move to single-use manufacturing has prompted a paradigm shift in facility design.

BioPharm International Supplements
Volume 26, Issue 4, pp. s27-s30


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 market manufacturing.

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 itself.

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,
ALAIN PRALONG* is vice-president of New Product Introduction & Technical Life Cycle Management, GlaxoSmithKline Vaccines Wavre, Belgium,

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