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Aug 1, 2010 (Vol. 30, No. 14)

Integrating Methods for mAb Production

Distinct Advantages Result from Combining a Broad Array of Tools and Technologies

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    GE Healthcare’s ReadyCircuit assemblies and ReadyKart mobile processing station are quickly configurable and assembled for sterile bioprocessing needs including crossflow and normal flow operations.

    Scientists working in the bioprocess arena have a lot on their plates lately, including choosing between single-use and stainless steel equipment, integrating processes and instruments, and improving resource and facility utilization. Tool companies are scrambling to do their part to help customers by introducing enabling products that seek to ease some of the challenges and reduce many of the costs.

    Andreas Muranyi, Ph.D., section manager of antibody processing at GE Healthcare, believes that GE’s Ready-to-Process™ (RTP) line of bioprocess equipment is a solution to several of the industry’s woes.

    RTP encompasses the Wave Bioreactor™ and Cellbag disposable bioreactors; ReadyCircuit fluid-management bags, tubing, and connectors; aseptic connectors; filters; chromatography columns; and the ÄKTA ready chromatography system. Dr. Muranyi says that a fully disposable purification line utilizing his company’s RTP downstream components can provide greater than 80% yield while reducing aggregate levels by 90%.

    GE’s approach leans heavily on PAT, QbD, and facility utilization, with an eye on time-to-market. “A large proportion of the expenses incurred during monoclonal antibody production are tied up in facility, floor space, installed equipment, and staff, which costs a lot of money whether you use them or not. The easiest way to reduce the cost per gram of active ingredients is to use the facility and related resources efficiently.”

    RTP’s range reportedly extends over nearly every unit operation in a typical bioprocess, particularly downstream. During chromatography column changeover, the switch from conventional packed columns to prepacked ReadyToProcess columns saves about four hours (11 vs. 7), while use of the ÄKTA ready system reduces changeover time to just two hours, according to Dr. Muranyi.

    “The change provides the equivalent of a full extra day for productive work.” Similarly, he says that changing from GE’s Kvick™ Lab filters to ReadyToProcess disposable hollow fiber membranes provides a time savings of about 30% (4.5 hours vs. 6.5 hours). Although the processing time is more than three times longer for RTP membranes, pre-use cleaning, membrane rinsing, and CIP/storage are eliminated for the disposable filters.

    One question suppliers of single-use equipment enjoy answering more than any other is, “What is the sweet spot, in terms of scale or stage of development, for using disposables?” The answer, Dr. Muranyi wryly notes, is usually related to the sizes and scale of the equipment that a particular vendor sells. He then cites the futility in applying a uniform algorithm to all companies, processes, and molecules. Still, some generalities emerge.

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