Pharmaceutical Technology December 2017

December 2017 | Volume 41, Issue 12
Pharmaceutical Technology December 2017 Issue
Cover Story
Attracting and retaining qualified bio/pharma experts demands a mix of recognition, rewards, and opportunities.
Issue PDF
By Pharmaceutical Technology Editors
Click the title above to open the Pharmaceutical Technology December 2017 issue in an interactive PDF format.
Features
Softgel capsules are a popular dosage form among patients but they also provide a number of manufacturing benefits over liquid-filled hardgel capsules.
Modified-release lipid-based formulations in softgel capsules can address physiochemical and pharmacokinetic challenges posed by drug compounds.
Optimizing water and HVAC systems can reduce resource use in all pharma facilities, and, for biopharma manufacturing, the supply chain of consumables should be evaluated.
Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.
A QbD approach can address manufacturing complexities in transdermal patch manufacturing.
Medherant has developed an improved instrument for testing drug release from transdermal patches.
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.
A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.
Regulatory Watch
The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.
New gene therapies and combination products require innovative regulatory approaches.
Peer-Reviewed Research
In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.
API Synthesis and Manufacturing
For many processes involving hazardous chemistry, running in flow mode has safety and economic advantages.
Outsourcing Outlook
In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.
From the Editor
Is pharma up to the task of developing knowledgeable, motivated employees?
Ask the Expert
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Product Spotlight
By Pharmaceutical Technology Editors
The Hiden ExQ quantitative gas analyzer is a mass spectrometer system providing continuous on-line analysis of dynamic gas streams at pressures from sub-atmospheric up to 30 bar.
By Pharmaceutical Technology Editors
The VERSA Telemanipulator from Central Research Laboratories (CRL), a Destaco company, is suited for remote-handling applications that involve specific customization requirements.
By Pharmaceutical Technology Editors
The Ross, Charles & Son Ross X-Series is a clean-in-place (CIP) ready ultra-high shear mixer for inline emulsification, particle size reduction, and homogenization.
By Pharmaceutical Technology Editors
The InMotion Karl Fischer (KF) Oven Autosampler from Mettler Toledo is suited for KF titration and comes in two models, InMotion Flex and InMotion Pro, and allows up to 26 samples to be analyzed on a 25-centimeter platform.
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