Genetic Engineering & Biotechnology News

NOV15 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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Genetic Engineering & Biotechnology News | GENengnews.com | NOVEMBER 15, 2017 | 27 prehensive set of information must be col- lated. One of the biggest challenges is that the relevant types of information, data, and knowledge required exist in disparate sys- tems and formats. These data include: • Chemical or biological substance information (chemical structures or sequence information) • Process information (unit operation conditions, materials used, location, equip- ment information, operator identification, suitable references to operating procedures and training, and calibration records) • Unit-operation specific molecular composition characterization data (spectral and chromatographic data collected to identify and characterize compounds and mixtures, such as data from LC/MS, NMR, UV, and IR instrumentation) • Composition differences in materials between specific unit operations and across all unit operations • Comparative information for each batch for a single "process," which is a single set of unit operations that are em- ployed to produce a product or substance • Comparative information for any or all employed processes. Cross-functional development project teams, composed of representatives from the various groups and departments that gener- ate the data and make decisions from it, spend many hours sourcing and assembling the nec- essary information. For each process itera- tion, effort is needed to acquire and evaluate new data, to analyze and interpret results, and to reassess the variance in impurity profiles for each process and across all processes. One of the major challenges is that while spreadsheets tend to be quite effective for handling numbers and relating them in cer- tain specified ways to calculate values such as sums and averages and make simple graphs, they are not very effective at han- dling and relating chemical structures with the analytical spectra and chromatograms used to identify them. Without a system that dynamically relates different kinds of input—chemical and analytical data, as- sessments of variance information, and the interpretative knowledge generated by com- puter algorithms and scientists—a tremen- dous number of full-time equivalent (FTE) days are spent just repeatedly searching for and compiling data, which presents a sig- nificant productivity challenge for project teams (Figure 2). An Integrated Platform Users need the ability to simply aggregate all of the information, data, and knowledge in a single, integrated, and interoperable platform. Project teams must be able to search, review, and update the information on a continual ba- sis as projects progress and evolve. Data access should support sharing of data for collabora- tive research while protecting data integrity. Furthermore, from the perspective of pre- serving the rich scientific information therein, an ideal informatics system will also limit the need for data abstraction. While data abstrac- tion serves a purpose—reduction of volumi- nous data to pieces of knowledge—it also brings limitations since important details, knowledge, and contextual information can be lost. In order to address all these challenges, a next-genera- tion informatics infrastructure is required. Discussions with development teams in the world's largest R&D organizations revealed an unmet need in their ongoing struggles assem- bling and effectively managing process data. In response, Advanced Chemistry Development (ACD/Labs) created Luminata™. This infor- matics system, built on the ACD/Spectrus, a well-established multi-technique vendor-agnos- tic platform for analytical data management, addresses many of the challenges of effective process management for impurity control. Luminata provides the ability to construct "process maps" enabling visual comparison of molecular composition across unit operations (Figure 3). The software allows the user to cap- ture and associate the wide variety of related spectroscopic and chromatographic data in a single environment for each stage and substance. The technology goes beyond simple data capture by storing the context of the experi- ment and the expert interpretation and de- cisions resulting from it. Dynamic visualiza- tion of this assembled, live (instantly re-use- able), and aggregated information preserves data integrity while supporting quick and confident decision-making and making bet- ter use of highly talented individuals. Finally, Luminata makes possible the full review of project information, from batch to support- ing data, in a single environment. Reference 1. N.N. Taleb, Antifragile: Things That Gain from Disorder, (Random House, New York, NY, 2012). Bioprocessing Figure 3. A screenshot from Luminata™, software for the management of impurity data. Figure 2. An idealized impurity management workflow. Detection of human BRD4 by rabbit anti-BRD4 recombinant monoclonal antibody Cat# A700-004 [BL-149-2H5] in WB of IPs (left) and WB of whole cell lysates (right). Rabbit anti-BRD4 recombinant monoclonal antibodies Cat# A700-004 [BL-149-2H5] and Cat# A700-005 [BL151-6F11], and affinity purified polyclonal antibody Cat# A301-985A100 used for IP (left). * Berglund, L., et al. A Genecentric Human Protein Atlas for Expression Profiles Based on Antibodies. Molecular & Cellular Proteomics, 7, 2019-27 (2009). Studies show only 50% of antibodies can be trusted to work the way they're designed to.* That's where Bethyl is different. With the standards and experience of over 40 years, we produce antibodies that deliver reliable results. We manufacture and validate everything on-site to ensure target specificity and sensitivity. All to guarantee our antibodies will function as designed in your assay 100% of the time. Choose Bethyl. We put a lot in every drop. Discover free shipping † with your next trial size order: BETHYL.COM/SHIPTRIALFREE17 kDa IP/WB 460– 268– 238– 171– 117– 71– 55– 41– A301-985A100 A700-004 A700-005 BL5482 Control lgG IP + – – – – + – – – – + – – – – + + – – – + – – – – BRD4 55– kDa 460– 268– 238– 171– 117– 71– 41– 31– HeLa 293T Jurkat MCF7 HEPG2 A549 SW620 SK BRD4 † Terms & Conditions Apply. Please see website for trial sizes and complete details. ©2017 Bethyl Laboratories, Inc. All rights reserved. Detection of human BRD4 by rabbit anti-BRD4 recombinant monoclonal antibody Cat# A700-004 [BL- 1 49-2H5] in WB of IPs (left) and WB of whole cell lysates (right). Rabbit anti-BRD4 recombinant monoclonal antibodies Cat# A700-004 [BL- 1 49-2H5] and Cat# A700-005 [BL 1 5 1-6F 1 1], and affinity purified polyclonal antibody Cat# A3 0 1 -985A 1 00 used for IP (left). * Berglund, L., et al. A Genecentric Human Protein Atlas for Expression Profiles Based on Antibodies. Molecular & Cellular Proteomics , 7, 2 0 1 9 -27 (2009). Studies show only 50% of antibodies can be trusted to work the way they're designed to.* That's where Bethyl is different. With the standards and experience of over 40 years, we produce antibodies that deliver reliable results. We manufacture and validate everything on-site to ensure target specificity and sensitivity. All to guarantee our antibodies will function as designed in your assay 1 00% of the time. Choose Bethyl. We put a lot in every drop. D iscover free shipping † with your next trial size order: BETHYL.COM/SHIPTRIALFRE E 1 7 kDa kDa IP/WB 460 – 268 – 238 – 171 – 117 – 71 – 55 – 41 – A301-985A100 A301-985A100 A700-004 A700-005 BL5482 Control lgG IP + – – – – + – – – – + – – – – + + – – – + – – – – BRD4 55 – kDa kDa kDa kDa 460 – 268 – 238 – 171 – 117 – 71 – 41 – 31 – HeLa 293T Jurkat MCF7 HEPG2 A549 SW620 SK BRD4 † Terms & Conditions Apply. Please see website for trial sizes and complete details. ©2017 Bethyl Laboratories, Inc. All rights reserved. Tutorial Andrew Anderson is vice president of innovation and informatics strategy, Graham A. McGibbon, Ph.D., is director of strategic partnerships, and Sanjivanjit K. Bhal, Ph.D., is director of marketing and communications at Advanced Chemistry Development (ACD/Labs). Website: www.acdlabs.com.

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