No Preparation Required
Through its ReadyToProcess™ (RTP) initiative, GE Healthcare improves multiple-use products by transforming them into a single-use, preconditioned, ready-to-use format. The idea is to eliminate for the end-user the flushing, sanitization, cleaning, and related validation, which Gerard Gach, director of marketing for biotechnology, describes as “wasted time” because they do not add value to core activities like making drugs. “All prep steps do is consume labor, assets, and consumables.”
As their name implies, RTP products are sold ready-to-use out of the box, for single processes or campaigns, thereby addressing needs of speed, simplicity, intuitiveness, safety, and less risk.
GE recently teamed with Novavax on a manufacturing platform that includes preconditioned hollow-fiber filter assemblies, which significantly reduced the time and cost associated with setting up a vaccine manufacturing facility. The filters, which are sold under the ReadyToProcess Hollow Fiber brand, address the need in vaccines for aseptic processing. GE will be introducing hollow-fiber products that have an even higher validation claim for sterility some time in 2009.
Hollow-fiber filtration is, of course, not new, and many users already employ them as de facto disposables. The new RTP line will reflect the added need for speed and reliability, since the membranes come preconditioned (factory flushed with water-for-injection and gamma-irradiated), and generally require no preparation or user validation. Typical applications include ultrafiltration/diafiltration, concentration, fractionation, and clarification. Both ultrafiltration and microfiltration cut-offs are available as ReadyToProcess.
GE is also re-casting its normal-flow filters, particularly its 0.2-micron sterilizing-grade products, in RTP format and increasing their capacity for suitability to large-scale bioprocessing. The ULTA™ line of capsules will incorporate a prefilter plus the sterilizing-grade membrane in one unified RTP kit.
Similarly, the company has developed a line of bioburden-reduction filters, the ULTA-CG line, for applications where sterilizing-grade is overkill, for example right before a chromatography step. “There are many situations where the performance and cost of a 0.2-micron filter is unnecessary, where five-log reduction is enough,” observes Gach.
Recognizing that some users may be unfamiliar with the intricacies of modern filtration, particularly when using new products, GE now offers a free, online filtration-optimization service. The website, www.filterbrain.com, allows users to optimize their filtration selection process in about 15 minutes.
A lot has been written about platform process operations, which seek to standardize a company’s manufacturing. Companies are particularly interested in template monoclonal antibody purifications, particularly for early clinical trial manufacturing. Given the advances in upstream productivity, companies are facing bottlenecks during purification.
“Customers are increasingly concerned about cost of ownership and are constantly looking to improve efficiencies by improving yield, reducing CIP/SIP requirements, and minimizing equipment downtime,” says Mani Krishnan, director of downstream processing at Millipore.
Millipore’s 2006 acquisition of Newport Biosystems provided access to the disposable, integrated Mobius product line that incorporates filtration, containers, and connectors. The company’s disposable Millistak+ POD depth filters can “significantly improve” overall cost of ownership for primary and/or secondary clarification steps, according to Krishnan. The company has also launched the Express PES (polyethersulfone) sterilizing-grade filters that deliver high flow rate and capacity, high microorganism retention, and broad pH compatibility.