Clinical Trial Research Center

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  BioLevitator™
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  Marken Solo™ Clinical Trials Management System
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  Veladisc ASME Code Module Housings
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  Thermo Scientific HyClone Single-Use Bioreactor (S.U.B.)
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  DASGIP pH Monitoring Modules
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  MET ONE 7000 Series Remote Airborne Particle Counters
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  Laboratory Incubator Shakers, Innova 42 & Refrigerated 42R, For On Or Under The Bench Or Double-Stacked
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  BIOsystem Box For Biologics Transportation

GUEST COLUMN

• What Are You Really Outsourcing When Using Single-Use Systems?

  The benefits of utilizing single-use systems (SUS) within the biopharmaceutical industry are well documented in the popular press and heralded at many conferences. At a fundamental level, they present exciting and often unprecedented opportunities in terms of increased productivity, the ability to make rapid capacity adjustments and lower the overall costs of manufacturing. However, what an end-user is effectively outsourcing when they choose to include single-use assemblies within a given process step, or as the scope of their implementation broadens to include an entire process, must be considered. As single-use adoption has advanced from a curiosity to an implemented business reality for many pharmaceutical companies over the past decade, it’s relevant to explore a few key concepts that should be addressed. By Max Blomberg and Christian Julien, Meissner Filtration Products

• Single-Use Budgets In 2013: Biotech Industry Council Indicates Industry Will Expand Spending On Key Products

  Disposable products continue to be a hot topic in biomanufacturing, as they increasingly penetrate clinical- and commercial-stage manufacturing and are sought after for their process efficiencies. In fact, when we asked the 450 global subject matter experts and senior participants on our Biotechnology Industry Council™ to identify the critical trends in bioprocessing for 2013, 22% cited aspects associated with implementation of single-use system integration.  These ranked narrowly behind need for downstream processing optimization, and analytical methods development (each at 24%). By Eric Langer, president and managing partner, BioPlan Associates, Inc.

• Budgets For Single-Use Systems On The Rise; CMOs The Biggest Spenders

  Single-use systems are rapidly becoming mainstream in the biopharmaceutical industry, even in commercial manufacturing.  Results from our 9th Annual Report and Survey of Biopharmaceutical Manufacturers indicate that budgets for single-use components are also on the rise, meaning this trend is likely to continue. By Eric Langer, President and Managing Partner, BioPlan Associates, Inc.

• Biomanufacturers Looking For Single-Use Innovations

  Single-use innovation continues to be a hot topic, according to results from our 9th Annual Report and Survey of Biopharmaceutical Manufacturers. In fact, disposable products account for three of the top five new product development areas of interest this year among the 302 biomanufacturers we surveyed (the study evaluated 21 different new product areas).  By Eric Langer, President and Managing Partner, BioPlan Associates, Inc.

• Single-Use Technologies Used Less For Downstream Purification Issues: Interest In Specific Technologies Remains Relatively Steady

  Downstream operations continue to create challenging bottlenecks and capacity problems. To identify what the industry is doing to address these bottlenecks, we asked 302 biopharmaceutical manufacturers in our 9th Annual Report and Survey of Biopharmaceutical Manufacturers about the specific areas their facility has actually implemented to improve their downstream purification (DSP) operations. By Eric Langer, president and managing partner, BioPlan Associates, Inc.

• Executive Insights Into Single-Use: Barbara Paldus Of Finesse Barbara Paldus, CEO, Finesse, LLC, joined an executive roundtable with Rob Wright of Life Science Leader magazine to discuss single-use technology. The intent -- gain a better understanding of the impact single-use technologies has on the biopharmaceutical manufacturing industry and the environment. Enjoy Paldus’ executive insights with regard to single-use for all nine of the questions posed to the original roundtable.

• Article: How To Choose An Industrial Cation Exchanger For IgG Purification Cation-exchange chromatography is the third most used industrial method for antibody purification after anion-exchange and protein A affinity chromatography. It is most commonly used as an intermediate step but continues to attract attention as a capture method. By Pete Gagnon