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Dolomite aids drug encapsulation studies

12 January 2016 | By Dolomite

A Dolomite microfluidic system is helping Dr Samar Damiati, Assistant Professor in the Biochemistry Department at King Abdulaziz University in Saudi Arabia, perform drug encapsulation studies...

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PAT In-Depth Focus 2015

6 January 2016 | By

Featuring an overview of process analytical control; Beyond API monitoring: in-line Raman spectroscopy for process control; Monitoring, understanding and assessing pharmaceutical process and product quality; and a PAT roundtable...

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Use of the ‘purge tool’ in assessing mutagenic impurities

6 January 2016 | By Dave Elder, GlaxoSmithKline and JPAG

The International Conference on Harmonization M7 text provides guidance on establishing acceptable levels of mutagenic impurities (MIs) . It also outlines the safety and quality risk management processes that manufacturers need to undertake to control MIs that may potentially affect the drug substance or drug product. Over the past decade,…

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The limitations of the colony-forming unit in microbiology

6 January 2016 | By Tony Cundell, Microbiological Consulting LLC

The recent revision to USP General Informational Chapter Validation of Alternative Microbiological Methods that became official on December 1, 2015 contained a section discussing the limitations of the colony-forming unit (CFU) in terms of enumerating only those microorganisms that readily grow on solid microbiological media. The section highlights its inappropriateness…

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Designing a novel continuous manufacturing plant with superior monitoring and control

6 January 2016 | By Ravendra Singh, Jun Zhang, Marianthi Ierapetritou and Rohit Ramachandran, The State University of New Jersey

There is a growing interest in manufacturing the pharmaceutical product continuously . Along with other advantages , it provides an appropriate platform to implement suitable monitoring and control architecture, to improve the product quality and minimise product rejection and operating expenses. Continuous pharmaceutical manufacturing can be also considered as a…

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Existing drugs show promise as antibiotic agents

4 January 2016 | By Victoria White

University of Illinois researchers have found that a number of existing drugs approved for the treatment of various conditions, such as cancer or infertility, show promise as antibiotic agents...