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Single-use technologies, which started off as a tool for small-volume solution storage and transport has now become the central, enabling technology around which manufacturing processes and facilities are being designed.
Single-use technologies continue to evolve rapidly as more biopharmaceutical companies embrace the concept and start implementing single-use systems in their bioprocesses.
It would be hard to overstate the impact that single-use systems are having on the biologics manufacturing industry. What started off as a tool for small-volume solution storage and transport has now become the central, enabling technology around which manufacturing processes and facilities are being designed. Several developments in the industry are driving this change. Within development laboratories, scientists have pushed product titers in cell cultures to levels that are commonly 20-fold higher than those realised 15 years ago.
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Biosimilars (i.e., follow-on versions of innovator biologic products that are at or near patent expiry) offer the opportunity for companies to commercialise products in a condensed timeline for an existing patient population. Given the enormous revenue of some innovator products, the ability to win even a small share of the existing market or open up new markets can be a rich reward to the biosimilar producer. Further, the desire of many governments to have “in-country, for-country” manufacturing of drugs for their population has created the need for smaller, light-asset production facilities designed to meet the local demand.
These developments have driven focus to the 2000-L single-use bioreactor as the centre piece of future manufacturing strategies. The productivity of the current 2000-L single-use bioreactor meets or exceeds that of the 20,000-L stainless-steel bioreactor of legacy processes, with all of the benefits of a single-use system. These include reduced utility requirements for steam-in-place and clean-in-place operations, faster turnover times between batches or products and reduced risk of cross-contamination.
Operation at the 2000-L bioreactor scale also enables the implementation of single-use systems throughout the manufacturing process, most notably in media and buffer preparation and intermediate product mixing and hold steps, and in many cases, fully disposable chromatography, tangential flow filtration, and clarification and virus filtration operations.
Even at the final filling stage, adoption of single-use technology is growing rapidly. The facility to operate these processes can be built, commissioned and qualified in 12 to 18 months at capital costs that are a fraction of a traditional facility. This allows companies to move aggressively into the biosimilars market at lower financial risk and, more importantly, allows for production of much needed medicines closer to the patient regardless of their location. This is the promise and the power of single-use systems.
About the Author
Michael Felo is group product manager, Single Use, at EMD Millipore.