Monday, February 10, 2014

BioProcess International: Toward Flexible Hybrid Facilities of the Future

Today's authors are Jeffery Lee Craig is Global Director of Business Development and Marketing, ATMI LifeSciences and Michael Jenkins, General Manager, Catalent Pharma Solutions

As the bioprocessing industry has shifted away from traditional stainless steel bioreactors and vessels toward single-use technology, a new breed of manufacturing facilities has arisen. Flexible facilities take full advantage of traditional multiuse technologies and combine them with increasingly popular single-use technologies, offering an ability to mitigate risk and decrease manufacturing timelines. Although some companies have made the choice to remain strictly traditional (multiple use) and others have moved fully into single use, the flexible hybrid format gives manufacturers the “best of both worlds.” That paves the way for a new and more effective approach to bioprocessing.

Here, we discuss the definition of a flexible facility and why Catalent Pharma Solutions chose to go with such a format. It partnered with ATMI LifeSciences throughout the process of moving from a 43,000-ft2 facility in Middleton, WI, to a 100,000-ft2 site in nearby Madison, WI. The Wisconsin production facility houses Catalent's proprietary GPEx technology (for mammalian cell line engineering) for rapid engineering of stable mammalian cell lines that express biopharmaceutical proteins. Typical fed-batch processes give a high production concentration of 2–5 g/L. The facility also offers process development, analytical development, and current good manufacturing practice (CGMP) manufacturing with GPEx and other mammalian cell lines. The current facility allows recombinant proteins to be manufactured in small vessels (up to a 200-L scale) for the CGMP production of phase 1–2 clinical trial supplies using traditional stainless steel bioreactors.

 The original expansion of the Middleton facility was in planning about five years ago, when necessary conventional stainless steel bioreactors (up to a 2,000-L scale) were purchased. However, that project was put on hold during the economic down-turn, and it was revisited only a couple years ago once demand began to reach available capacity. Rather than simply implement the original expansion design, however, Catalent took time to return to the drawing board and decided to create a fully flexible facility in a nearby available building. That structure had a large open area that would be ideal for build-out of CGMP suites, but it lacked the infrastructure required for stainless steel bioreactors (e.g., for delivery of clean steam). During the initial evaluation, purchases that had been made already were kept in mind along with considering the advantages of single-use technologies on the market. Catalent already had extensive experience with disposables, having used Wave bioreactors from GE Healthcare as part of its CGMP seed train as well as bioprocessing bags for buffer preparation and storage of process intermediates.

To implement the original plan in stainless steel with a fixed plant would have involved the cost of additional piping for steam-in-place (SIP) systems as well as expensive support equipment for clean-in-place (CIP) systems. Catalent determined that building a facility that would rely on single-use vessels would require other infrastructure upgrades, but that elimination of fixed pipework would lower those costs and leverage established advantages of disposables to the facility. Factors such as a decreased risk of cross-contamination, faster suite turn-over between production runs, and shortened construction time helped to solidify the final decision. Catalent chose to sell its unused stainless steel reactors — they had not even been unpacked — and purchase single-use reactors to carry out production runs.

You can view the full article here. BPI will be joining us February 10-12 for IBC's 2nd Annual Flexible Facilities conference taking place this February. To learn more, view our agenda. Register with code FLEX14BLOG and save 20% off of the standard rate.We hope to see you February 24-25 in Berkley, CA!

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