The mission statement for most biopharmaceutical companies is to bring lifesaving therapies to patients anywhere in the world. The challenge is to produce drugs that are cheaper, better, and faster to market than ever before. Drug developers are faced with important strategic questions that can lead to success or failure: Will the clinical trial be successful? When do we invest in manufacturing capacity? Are the forecasts accurate? Should we outsource? Will someone else get there faster? These are all questions being asked as novel biologics continue to enter the market and demand for more affordable and effective treatments grows.
Advances in manufacturing have facilitated faster production of high efficacy products in regulatory compliant environments. Platforms incorporating single-use technologies can be installed quickly, supplied ready-to-use components, and facilitate process advantages like high yields from smaller batch sizes. Disposable, functionally closed, systems have further value in minimizing contamination risk, requiring less validation, and can have lower running costs compared to stainless steel (ebook Evolve with Flexibility: Advancing Single-Use Technology with Industry Collaboration, April 2017). Modular and prefabricated facilities have also been successfully deployed reducing the lead time from design to production significantly.
GM Biopark & Commercial USCAN/LATAM, GE Healthcare
Why build warehouses that are only partially filled or stocked with excess raw materials to insure against supply chain disruption? What if it didn’t need to take between 36 and 48 months before market introduction to build your facility? Some of the answers may come from applying the principles of condominiums to biomanufacturing. Separately owned units with shared common areas such as warehousing, utilities, and liquid preparation rooms would reduce costs and startup time. With a biomanufacturing campus concept each biopharmaceutical manufacturer could be producing biotherapeutics within 18 months of a decision to build. Each manufacturer would own a manufacturing and administration area. Utilities would be distributed from a central shared facility; common goods would be stocked in the shared warehouse location, and each manufacturer would have a secure warehouse area. Buffer and media preparation would also be a shared area, reducing the need to purchase your own equipment while providing true, just in time delivery.
The time has come to think outside the facility box and investigate new ways to reach our goals. Efficiencies can be gained if we are willing to approach capacity expansion from a new perspective. The GE Enterprise team is attending the BIO 2017 to talk about the new ways to execute biomanufacturing and take the industry into the future.
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