The most recent significant addition has been the acquisition of Xcellerex on May 10, 2012. Xcellerex provides single-use
large scale stirred tank Bioreactors and mixers, complementing the WAVE Bioreactor line which currently meets a strong seed-train
need. In completing this acquisition, we have filled what was perceived to be a large gap in our offering (i.e., being able
to offer single-use, cell-culture capability to a 2000-L scale). Xcellerex also has strong facility design and services capabilities,
which have added to our overall offering in this market.
BioPharm: What specific industry need contributed to the idea to develop this platform?
Stortz: The primary drivers for
the need of single-use/disposable technologies were costs and time savings through increased footprint utilization for multiproduct
facilities and rapid turnaround between bioprocessing campaigns. It was unusual to see an industry prudently resistant to
disruptive technology adopt and shift in such a short time to single-use/disposable technologies throughout the upstream and
downstream unit operations. GE Healthcare Life Sciences identified this trend early and built a portfolio to meet the market
needs through organic product development as well as by acquiring technologies which could serve to provide an end-to-end
solution with easily adoptable unit operations interfacing with competitor single-use platforms or for hybrid applications
(i.e., mixing stainless-steel infrastructure processing skids with single-use polymer technologies).
BioPharm: What have been some of the challenges associated with the platform thus far?
Stortz: Deciding on single-use versus disposable technologies was a challenge. Certain unit operations such as NFF had seen single-use
products in bioprocessing as accepted practice for many years. In traditional chromatography applications, however, it was
difficult for most end users to consider using a column and system flow path once with product and then disposing of them.
While there were many advantages to not needing to perform cleaning validation on a prepacked, presanitized chromatography
column and an entire system flow path, it became clear that many of our customers would prefer to run multiple cycles for
the same product before discarding. To support our customers’ use of a product in a manner that was not originally anticipated
by us as the manufacturer, we needed to perform extensive product cycling testing to give customer the confidence to proceed
with using these products for multiple processing runs and cleaning cycles.
BioPharm: What are the next steps for the platform; are there any upgrades, different models, or other changes planned?
Attridge: The ReadyToProcess Platform has been evolving over the past five years, and we fully expect that it will continue to do so
as the industry continues to further adopt single-use/disposable technologies. Our strategy will continue to be to seek opportunities
in areas where we can enhance our capabilities with respect to satisfying our customers’ needs, not only from an equipment
or unit operations perspective, but also looking at services and tools that will be in greater demand with the broadened use
of single-use/disposables across the manufacturing process.