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Validation, Qualification and Calibration - SGS

21-Apr-2014 - This white paper outlines outsourcing requirements for Validation, Qualification and Calibration activities in a pharmaceutical facility. These ongoing activities cover development, operation, and maintenance and must meet high quality standards.
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Rocket 4D Automatic Evaporation of Large Volumes - Genevac

11-Nov-2013 - Why stay trapped in the glassy world of production scale rotary evaporators when freedom is at hand. You can exchange the need for frequent monitoring of the evaporation process and worries about handling unwieldy 20-litre or 50-litre glass flasks for...
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NEOBEE® MCTs Enhance Pharmaceutical Bioavailability - Stepan Lipid Nutrition

04-Nov-2013 - An efficient solvent for many lipophylic drugs and vitamins, NEOBEE® MCTs emulsify in aqueous environments and help uptake in intestinal cells. They are odorless, tasteless and extremely stable and offer a safe, versatile, affordable and simple solution for many bioavailability...
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New Guidelines for Stabilization of Proteins by Freeze Drying: Formulation and Process Heresy - Baxter

17-Oct-2013 - Over the years a number of informal guidelines or “rules” for the formulation and processing of proteins for freeze-drying have been developed. However, in recent years it has become obvious that some of these rules need modification. In this presentation,...
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How to Simplify Virus Production Process Scale-Up? - ATMI Life Science

30-Sep-2013 - Discover how to efficiently scale-up vaccine manufacturing processes by moving from 2-D vessels to the Integrity® iCELLis® series of single-use fixed-bed bioreactors. Learn more about results achieved for several virus production process developments and how the fixed-bed design of the...
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Simpler and Faster Viral Vector Production Scale-Up - ATMI Life Science

23-Sep-2013 - Discover how to efficiently produce wild-type or recombinant viruses to be used as vaccines and human gene therapy vectors. Learn more about results achieved for the production of AAV and a paramyxovirus in the Integrity® iCELLis® bioreactor developed by ATMI...
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Using Validated Technology to Increase Assurance of Integrity and Sterility of Single-use Assemblies Immediately Before Use - ATMI Life Science

29-Aug-2013 - Single-use bioprocessing technologies raise persistent concerns about integrity. Sterility of the bag must be maintained in order to avoid contamination resulting in the discarding of the batch, after significant cost and effort.Discover a new highly-sensitive technology for detecting defects in...
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Exploring New Frontiers in Direct to Patient Home Delivery Services for Clinical Trials Materials - Marken

07-Aug-2013 - Exploring New Frontiers in Direct to Patient (DTP) Home Delivery Services for Clinical Trial Materials provides an in-depth look at reasons to consider a DTP solution. Included in the discussion are concerns with the traditional distribution channels, advantages and challenges...
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Bioprocesses Simplification Using Fixed-Bed Bioreactor - ATMI Life Science

24-Jun-2013 - Discover the iCELLis®, a scalable line of disposable high-cell density bioreactors. By providing up to 500m² – equivalent to 3000 Roller Bottles of 1 700cm² each – the iCELLis system is designed to intensify and simplify adherent cell processes. 
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Virus Production: From Bench to Industrial Scale - ATMI Life Science

10-Jun-2013 - Discover the linear scale-up of various viral production process using the Integrity® iCELLis®, a scalable range of disposable fixed-bed bioreactors operating in perfusion mode.  By providing up to 500m² of growth surface area in only 25 liters reactor volume, the...
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How to Industrialize Stem Cell Culture Processes? - ATMI Life Science

27-May-2013 - Learn about the scale-up of allogeneic stem cell processes, from multi-tray stacks to the Intergity® XpansionTM multiplate bioreactor. Results demonstrated consistency of culture through scale-up, with similar cell density and viability as well as a preserved quality in terms of...
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Increase Integrity of Single-use Assemblies Immediately Before Use. - ATMI Life Science

20-May-2013 - Discover the HIT™ platform, a new highly-sensitive technology for detecting defects as small as 10 micron in single-use assemblies at the end-user facility.Learn more about the results achieved and the correlation between defect size and bacterial ingress probability.
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Discover innovative single-use mixer for efficient mixing of low shear and particulate sensitive solutions in cGMP environment - ATMI Life Science

23-Apr-2013 - The Integrity® LevMixer® single-use mixing system from ATMI LifeSciences is an innovative, low shear and low particulate mixing platform designed for manufacturing environments.  Discover and learn about how true superconductive levitation is the best technology for mixing product and other...
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IMA welcomes you to Interphex NY 2013 - DA VINCI is back: discover it at IMA LIFE booth! - IMA LIFE

15-Apr-2013 - Visit us at Interphex NY 2013 to discover our latest solutions for the processing and packaging of pharmaceutical products. IMA LIFE will launch DA VINCI, the latest breakthrough in Loading/Unloading systems. Don't miss the chance to know more about our...
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Industry Snapshot: Clinical Trial Trends Outline Complexity for Supply Chain - Marken

25-Mar-2013 - 2013 Industry trends driving the scientific, logistical and regulatory complexity of supply chain industry Implement clinical development methodologies for quality, relationships, and performance Strategies to optimize drug development to reduce global trial time and costs
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Extractables & Leachables Risk Assessment - SGS

04-Feb-2013 - An extractables and leachables case study describes how a comprehensive risk assessment was performed across the entire production process of a European manufacturing plant for 40 finished products, resulting in a global testing plan
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How a punch and die maintenance SOP improves your profitability and productivity - I Holland Limited

21-Jan-2013 - Tablet compression tools are often viewed as consumable items. I Holland believe that because they are replaceable, they shouldn't be viewed as disposable.  This webinar will explore how a professional maintenance SOP can increase your profitability 
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BASF’s Hot-Melt Extrusion Compendium – 2nd edition - BASF SE

08-Oct-2012 - The new edition provides readers with an even better understanding of solid dispersions and the hot-melt extrusion process. It offers an overview of BASF’s polymers, more real-world application data and factors to consider in the formulation process
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Simpler and More efficient Vaccine Manufacturing: Move from roller Bottles to iCELLis™ - ATMI Life Science

20-Aug-2012 - iCELLis™ is a scalable line of bioreactors combining the advantages of single-use technologies with the benefits of a fixed-bed system. By providing up to 500m² – equivalent to 3000 Roller Bottles - iCELLis offers a simpler alternative for process efficiency.
Download now!Case study

Efficient production combining smart synthesis & purification - Novasep

20-Aug-2012 - Molecules reaching the market in the recent years present an ever-growing complexity and purity criteria are more stringent than ever. The right combination of smart synthesis and advanced purification is necessary to meet the demand in a cost-effective and time-efficient...

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