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Biopharma Manufacturers Look For Product Innovation
1/27/2012
Biopharma manufacturers are increasingly vocal about the new product development (NPD) areas they need to increase productivity and improve quality. By Eric Langer, president and managing partner, BioPlan Associates, Inc.
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Securing Supply In Single-Use Systems — The Second-Source Decision
11/1/2011
The use of disposable systems for bioprocessing manufacturing has become a viable and cost-effective way for many pharmaceutical manufacturers to handle bioproduction requirements during clinical trials of drug candidates. By Wayne Koberstein
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Demand For New Downstream Technologies Is Driving Vendors’ R&D
10/31/2011
Vendors are investing heavily in new technologies and products for downstream purification. Today, both developers and CMOs are expecting that physical capacity of downstream purification equipment will continue to constrain facility capacity in the near term. By Eric Langer, president and managing partner, BioPlan Associates, Inc.
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Single Use Standards: Who’s Setting The Bar?
9/29/2011
Standards setting is a frequently cited stumbling block to single use systems' (SUS) acceptance. As adoption of SUS devices advance, there is a new urgency to press for setting standards. In our 8th Annual Report and Survey of Biopharmaceutical Manufacturing, 2011, we examined who is expected to be setting disposables' standards. By Eric Langer, president and managing partner, BioPlan Associates, Inc.
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Single-Use Devices — What’s REALLY Holding Up Adoption?
8/1/2011
Today, single-use products have pushed beyond early-stage applications. However, single-use devices still need to address a number of problems in GMP commercial-scale operations. By Eric Langer, president and managing partner, BioPlan Associates, Inc.
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Economic Analysis Of Single-Use Tangential Flow Filtration For Biopharmaceutical Applications
6/10/2011
Prior to creating an accurate economic model for TFF, a thorough understanding of the
process where the TFF is used is needed. A process model is a valuable tool when
properly executed and it must accurately include all critical aspects of the purification
process. By Michael LaBreck, Mark Perreault, Novasep
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A Universal Single-Use Mixer – Concept Or Reality?
6/1/2011
In recent years, various types of single-use mixers incorporating components such as paddles, stir-bars, recirculation loops, impellers and flat-bed rockers have been introduced. By Pall Life Sciences - BioPharmaceuticals
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Single-Use Saves Time For Contract Manufacturing Organization
6/1/2011
There are many reasons why a single-use approach is considered or adopted by pharmaceutical manufacturers. In a recent survey in 2010,1 the most important reason for the increasing use of disposables was elimination of cleaning (90.9% of respondents) and third was reduced cross-contamination (83.3%). By Pall Life Sciences - BioPharmaceuticals
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Single-Use TFF Systems – A New Era
6/1/2011
Only a few years ago, single-use tangential flow filtration (TFF) from bench scale to full production was not a practical consideration for the vast majority of pharmaceutical manufacturers. By Pall Life Sciences - BioPharmaceuticals