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Issue 5 2017

Determination of glucosamine in food supplements by HILIC-ESI-MS

20 October 2017 | By Dr Cristina Legido Quigley, Lin Zheng (King's College London and Guizhou Medical University), Min Kim (King's College London), Pei Han

Glucosamine is sold as a food supplement worldwide, but its production is poorly regulated. A direct and reliable method for the quality control of glucosamine in commercial products is of great importance. This article describes a simple, fast and validated ultra-performance liquid chromatography-quadrupole time of flight (UPLC-QToF) for the determination…

Issue 5 2017

Microbiology In-Depth Focus 2017

19 October 2017 | By European Pharmaceutical Review

The European Pharmacopoeia chapter on methods for microbiological quality control was recently revised to include a number of significant changes. In this In-Depth Focus Michael Miller provides the first part of this two-part review and Kevin Williams discusses a paradigm change in biologics microbiological contaminant control.

Issue 5 2017

Sample preparation – is it possible to have too much?

18 October 2017 | By Tony Edge (Agilent Technologies)

In the field of bioanalysis, the use of sample preparation is fundamental to ensuring that data is robust. This article looks at some of the various forms of sample preparation that are commonly used for the pre-treatment of biological fluids and considers the advantages and disadvantages of each approach.

Issue 5 2017

Guide to Outsourcing

18 October 2017 | By European Pharmaceutical Review

Welcome to European Pharmaceutical Review’s Guide to Outsourcing, the fourth in our series of ‘Guide to…’ supplements. In this edition, five leading companies that provide outsourcing services explain how their portfolio meets current industry needs.

Issue 5 2017

A paradigm change in biologics microbiological contaminant control

17 October 2017 | By Kevin L Williams

Contaminant detection methods derived from the innate, proinflammatory responses of rabbits and Limulus blood have been used to determine the existence of microbial artefacts in small-molecule drugs (SMDs) and large-volume parenterals (LVPs) for decades...

Issue 5 2017

Issue #5 2017 – Digital Version

17 October 2017 | By European Pharmaceutical Review

In this issue: Sample preparation - is it possible to have too much? Developing successful over-the-counter syrup packaging for the highly regulated EU market. In-line process PAT in continous wet granulation, and much more...

Paying it forward in PhRMA

9 October 2017 | By Dr Zara Kassam (European Pharmaceutical Review)

As part of EPR’s Women in Pharma series, Lori Reilly, Executive Vice President, Policy, Research & Membership, talks to Science Editor Dr Zara Kassam about the importance of having strong female mentors...

Ensuring successful serialisation data management ahead of the EU FMD

4 October 2017 | By Jean-Marie Aulnette

Traceability and serialisation have been the talk of the industry for many years, with regulatory bodies worldwide starting to introduce legislation that will help to eradicate counterfeit medicines from the supply chain.

Turning challenges into solutions at Merck

3 October 2017 | By Dr Zara Kassam (European Pharmaceutical Review)

As part of EPR's Women in Pharma series, Petra Wicklandt, Senior Vice President, Head of Global Chemical and Pharmaceutical Development, Merck, talks to Science Editor Dr Zara Kassam about facing challenges in the pharmaceutical industry and turning them into solutions...

17th-century style science in the 21st century? The case of the Alzheimer’s disease vaccine

3 October 2017 | By Dante J Marciani

Dante J Marciani, President and CSO of Qantu Therapeutics, reviews the current evidence and controversy in the hunt for a vaccine against Alzheimer's disease and considers the future.

A comprehensive review of the newly revised European Pharmacopoeia chapter 5.1.6

31 August 2017 | By Dr Michael J. Miller

European Pharmacopoeia Chapter 5.1.6, Alternative Methods for Control of Microbiological Quality, was recently revised and published in Ph. Eur. Supplement 9.2. The new chapter comprises a number of significant changes from the original version published in 2006. Prior revisions to a similar chapter and technical report from the USP and…

Issue 4 2017

compressed gases environmental monitoring lab equipment

Compressed gases: an important component of an environmental monitoring programme

25 August 2017 | By Claudio Denoya, Daniele Pandolfi, Frank Panofen

The quality attributes of manufactured pharmaceutical products include the physical, chemical, and microbiological characteristics of the raw materials, excipients and active pharmaceutical ingredient (API), as well as the final drug product (see Table 1). Absence of microbiological contamination is considered a critical quality attribute due to its potential to dramatically…

Issue 4 2017

Quality Assurance and Control in-depth focus 2017 cover

QA/QC In-Depth Focus

25 August 2017 | By European Pharmaceutical Review

In this In-Depth Focus: Quality control of freeze-dried oral formulations; Regulatory and quality assurance challenges in continuous manufacturing...

Issue 4 2017

Environmental Monitoring In-Depth Focus 2017

24 August 2017 | By European Pharmaceutical Review

In this in-depth focus: Compressed gases - an important component of an environmental monitoring programme; The people factor - contamination of cleanrooms caused by personnel...

Issue 4 2017

Guide to Ingredients

23 August 2017 | By European Pharmaceutical Review

In this guide to ingredients, two leading companies involved in testing and analysis explain how their service offering meets current industry needs...