Genetic Engineering & Biotechnology News

AUG 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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22 | AUGUST 2017 | | Genetic Engineering & Biotechnology News Earlier this year, the Watson-Marlow Fluid Technology Group (WMFTG) unveiled its Quantum peristaltic pump with a ReNu sin- gle-use technology cartridge. The product is intended for downstream processing. GEN recently interviewed Tony Barrass, product manager, about the company's new offering. GEN The company notes that the Quantum provides a revolutionary single-use approach to downstream bioprocessing. How does it do so? Mr. Barrass Quantum redefines pump per- formance in several ways. First of all, it has a 4-phase peristaltic pump technology that delivers low pulsation and ultra-low shear performance. The product is the lowest- shear product available that also has linear flow control. It offers a single-use fluid path with a comprehensive set of validation data. Quantum also is a flexible product with a wide flow range (5.33 mL/min up to 20 L /min). Flow is independent of outlet pres- sure. In addition, Quantum has a down ratio (4000:1), which provides excellent control resolution. GEN How specifically does the Quantum differ from other pumps on the market? Mr. Barrass Other options, like quaternary diaphragm pumps, have greater pulsation and complex flow paths, where sensitive flu- ids are forced through narrow apertures at high frequency. This creates high shear forces and cell damage, which can be avoided by using the ReNu SU technology cartridge with its simple flow path. Quantum also has advantages over cen- trifugal pumps, which have poor flow con- trol, limited flow range, and a nonlinear response. GEN What are the major benefits of the Quantum? Mr. Barrass Closed-loop speed control and the linear flow characteristic, coupled with virtually pulse-free flow, means that main- taining transmembrane pressure in filtration applications is greatly improved over com- petitive technologies. Quantum is also excellent in other ap- plications that require gentle transfer and a wide flow range. This includes chromatog- raphy systems, where Quantum provides a low-speed priming capability. GEN What is the importance of the ReNu SU technology cartridge to the performance of the Quantum? Mr. Barrass The ReNu SU technology car- tridge is key to delivering the pump's flow stability and process control. The materials used in the cartridge also ensure a product that is sterilizable through gamma irradia- tion, with stable reliability and high pressure performance at levels up to 50 kGy. ReNu SU technology cartridges are also supplied with a validation guide. This allows customers to considerably reduce the cost and time it takes for pump validation prior to being specified into single-use systems. The guide includes a comprehensive set of biocompatibility data with material tests, such as USP88, Class VI (in vivo) and USP87 (in vitro). Detailed extractable testing with a range of solvents in line with BioPhorum Operations Group (BPOG) and Bio-Process Systems Alliance (BPSA) guidelines has also been undertaken. The validation guide supports customers with their validation process, reducing over- all time to market. Bioprocessing Perspectives Watson-Marlow has developed the Quantum peristaltic pump, which incorporates ReNu single- use technology. By installing different ReNu cartridges, users may switch fluid paths quickly while avoiding alignment errors. Quantum's combination of peristaltic and single-use capabilities may be particularly useful in tangential-flow filtration, virus filtration, and high-performance liquid chromatography. Upping Peristaltic Pump Performance Quantum Was Designed to Offer a Novel Single- Use Approach to Downstream Processing Insights Bioprocessing Although downstream processing moves much faster than in the past, obstacles remain as compa- nies pursue their individual biomanufacturing strategies. GEN spoke to Günter Jagschies, Ph.D., strategic customer relations leader, GE Healthcare Life Sciences, for his view of the downstream processing issue. GEN How significant a problem do downstream bottlenecks still pose to biomanufacturers? Dr. Jagschies These problems have typically been 'homemade' via a mismatch in dimensioning of tanks and sometimes chromatography columns with upstream productiv- ity increases. The more new facili- ties are inaugurated, or legacy ones get upgrades, the less of a problem [bottlenecks are]. Many companies are taking a scale-down decision to 1,000–2,000L reactor size and this removes the issue entirely. Use of recent-generation downstream processing (DSP) tools is important in all these scenarios. GEN What are the main downstream challenges? Dr. Jagschies Next-generation de- signed biotech medicines such as antibody derivatives, conjugates, or oligonucleotides pose different challenges, both for the capture step (affinity concept may not be available), and for the polishing phase, where unusual impurity profiles may challenge established process designs and classic chro- matography resins. Permanent adaptation of the selectivity and features portfolio is required. GEN What can be done to address downstream challenges and improve efficiency? Dr. Jagschies One key element in new developments is access to the problem for those who shall address the challenge, e.g., DSP technology suppliers. This requires close collaboration between R&D teams. Fast pro- cessing or continuous operation will not address these selectivity challenges. We will need to find new selectivities and will have to use a systematic approach to orthogonal combination of purification mechanisms. n Tackling Downstream Bottlenecks Günter Jagschies, Ph.D.

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