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Issue #1 2016 – Digital edition
In Issue #1 2016: Regulation, Drug Delivery, Raman, PAT, Formulation, NIR, Microbiology, and much more...
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Issue 1 2016
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NIR: In-Depth Focus 2016
In this NIR In-Depth Focus: Moving to fast chemical imaging techniques in process control; Progress in near-infrared techniques in biomedical research...
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Raman: In-Depth Focus 2016
In this Raman In-Depth Focus: Raman as a valuable tool in high-throughput screening; Use of Raman in analysing polymorphism in pharmaceutical drugs; Upcoming Raman calibration standards; Raman roundtable...
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Foreword: The evolving pharmacopoeia
Globalisation has facilitated greater international harmonisation and standardisation of quality standards, which in turn has impacted on pharmacopoeias1. Historically, general chapters were developed based on input from local regions with little concern for global consequences. This often led to the development of similar, but unidentical tests, for example, Residue on…
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Four trends that will transform healthcare in Europe in 2016
29 February 2016 | By Warren Hochfeld, Jenna Riffell and Neil Levinson from Kaiser Associates
With 2015 giving some hints of what is to come, the Kaiser Associates European Healthcare team are predicting another year of big disruptions, transformations and innovations as the healthcare industry continues to overhaul outmoded business models...
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The role of drug transporters at the blood brain barrier
29 February 2016 | By Jasminder Sahi and Yi Li, Sanofi R&D
The human brain is the most highly perfused organ in the body, being composed of over 100 billion capillaries with an average inter-capillary distance of 50μm and a length greater than 600km. This extensive network of blood vessels facilitates the delivery of nutrients and oxygen to the brain, while providing…
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The application of skip testing to drug substance manufacture
29 February 2016 | By Phil Borman, Simon Bate and Keith Freebairn, GlaxoSmithKline
Skip testing is a process employed to reduce the analytical drugs testing burden and lends itself to processes with high frequency batch production. Rather than test all batches within a given interval, pre-selected batches are assessed and the other batches ‘skipped’. This reduction is justified as it is shown that…
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Dissolution testing in the modern world
Historically, dissolution testing has been used primarily as a quality control (QC) test for solid oral drug products1. Indeed, it is the only QC test which provides a measure of the quantitative release rate of the drug from the pharmaceutical product. More recently, the test has been proposed in lieu…
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Expert View: Standardisation through automation
29 February 2016 | By SOTAX Group
There are several sources of variability in the “inherently poor design” of compendial dissolution apparatus types. Nevertheless, dissolution testing is a QC requirement for many products, and so the industry faces the challenge of implementing and managing fleets of dissolution equipment. However, through instrument and process design and automation, managing…
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The challenges of riskbased environmental monitoring in sterile product filling
Completing risk assessments is an inherent part of good manufacturing practice (GMP) and risk-based environmental control and monitoring (EM) in sterile product filling within isolators and restricted access barrier systems (RABS). This article considers the challenges the pharmaceutical industry faces in characterising conventional risk assessments like failure modes and effects…
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Upcoming Raman calibration standards
In this article, Kerstin Barr, Product Manager for handheld Raman instruments at Thermo Fisher Scientific, comments on the revised tolerances...
