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European Pharmaceutical Review – Digital Issues

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Latest Issue

 

European Pharmaceutical Review issue 6 2015

Issue #6 2015 – Digital edition

Author(s): European Pharmaceutical Review

In this issue: Microbiology, Screening, PCR, Continuous Manufacturing, PAT, Regulation, and much more…

Application Notes and Whitepapers supplement 2015

Application Notes & Whitepapers supplement 2015

Author(s): Stephanie Anthony

Our Application Notes & Whitepapers supplement covers a wide variety of applications, from NMR, biosensors, Raman spectroscopy and QC to hot-stage microscopy…

Screening In-depth Focus 2015

Screening: In-depth Focus 2015

Author(s): Caroline Richards

In this Screening In-depth Focus: High-content screening accelerates discovery rates in the life sciences; Phenotypic screening using 3D tissue culture and whole animal assays; Screening Roundtable…

PAT In-depth focus 2015

PAT: In-depth Focus 2015

Author(s): Caroline Richards

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…

Product Hub: Chemspeed’s SWILE© Automated Workstation

Product Hub: Chemspeed’s SWILE© Automated Workstation

Author(s): Dr. Michael Schneider, Sr VP BU Life Science for Chemspeed Technologies AG

Dr. Michael Schneider, Sr VP BU Life Science for Chemspeed Technologies AG, discusses Chemspeed’s SWILE© Automated Workstation (first true gravimetric one-to-one pick and dispense of compounds)…

David Elder

Use of the ‘purge tool’ in assessing mutagenic impurities

Author(s): 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, some of the most significant challenges facing the pharmaceutical industry have been linked to performing genotoxic risk assessments (GRAs) and implementing a control strategy, including the analysis of these MIs and potentially mutagenic impurities (PMIs) at very low levels (ppm) in drug substances and products…

The limitations of the colony-forming unit in microbiology

The limitations of the colony-forming unit in microbiology

Author(s): Tony Cundell, Microbiological Consulting LLC

The recent revision to USP General Informational Chapter <1223> 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 as a gold standard for method validation when there are many signals available other than CFUs for the detection, enumeration and identification of microorganisms in water, air, pharmaceutical ingredients and drug products…

MIQE compliance in expression profiling and clinical biomarker discovery

MIQE compliance in expression profiling and clinical biomarker discovery

Author(s): Irmgard Riedmaier, Melanie Spornraft, Benedikt Kirchner and Michael W. Pfaffl, Technical University of Munich

Molecular diagnostics and biomarker discovery are gaining increasing attraction in clinical research. This includes all fields of diagnostics, such as risk assessment, disease prognosis, treatment prediction and drug application success control. The detection of molecular clinical biomarkers is very widespread and can be developed on various molecular levels, like the genome, the epi-genome, the transcriptome, the proteome or the metabolome. Today, numerous high-throughput laboratory methods allow rapid and holistic screening for such marker candidates. Regardless of which molecular level is analysed, in order to detect biomarker candidates, high sample quality and a standardised and highly reproducible quantification workflow are prerequisites. This article describes an optimal and approved development strategy to discover and validate ‘transcriptional biomarkers’ in clinical diagnostics, which are in compliance with the recently developed MIQE guidelines. We focus on the importance of sample quality, RNA integrity, available screening and quantification methods, and biostatistical tools for data interpretation…

Designing a novel continuous manufacturing plant with superior monitoring and control

Designing a novel continuous manufacturing plant with superior monitoring and control

Author(s): 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 ‘data rich’ operation since data is continuously generated from the substantial experiments employed in the process development activities or process operation. Therefore, a systematic framework is needed through which suitable sensing and control architectures can be designed, developed, evaluated and implemented into a continuous pharmaceutical manufacturing plant. In addition, an efficient data management system is required for data storage, organisation and subsequent applications. The objective of this article is to introduce a continuous pharmaceutical manufacturing process and pilot plant, and highlight the process analytical technology (PAT), control and data management system integrated with it…

To float or not to float

To float or not to float?

Author(s): Sue Staunton, James Cowper Kreston

For many years, global markets had focused their attention on traditional sectors such as natural resources rather than on life science companies, so initial public offerings (IPOs) for such companies were uncommon. The past few years have, however, seen a sea-change and life science companies – from biotech to medical devices firms – have come very much back into favour as the must-have stocks; with opportunities for significant upsides. The turnaround started in 2013; the markets began to pick up that year and 66 life science IPOs were completed globally. By 2014, there were an extraordinary 133 life sciences companies completing IPOs, raising some $11 billion…

Arnaud Carlotti, President of Eurofins IDmyk

Under the microscope: Dr. Arnaud Carlotti, PhD, HDR, President of Eurofins IDmyk

Author(s): Caroline Richards

Caroline Richards, Editor of European Pharmaceutical Review, asks Dr. Arnaud Carlotti, PhD, HDR, President of Eurofins IDmyk, to provide his insights on the microbial testing industry…

Past Issues

Supplements

Supplements & Special Editions

 

Application Notes and Whitepapers supplement 2015

Application Notes & Whitepapers supplement 2015

6 January 2016

Our Application Notes & Whitepapers supplement covers a wide variety of applications, from NMR, biosensors, Raman spectroscopy and QC to hot-stage microscopy…

Screening In-depth Focus 2015

Screening: In-depth Focus 2015

6 January 2016

In this Screening In-depth Focus: High-content screening accelerates discovery rates in the life sciences; Phenotypic screening using 3D tissue culture and whole animal assays; Screening Roundtable…

PAT In-depth focus 2015

PAT: In-depth Focus 2015

6 January 2016

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…

RMM In-depth focus

RMM: In-Depth Focus 2015

22 October 2015

Implementation of a rapid methods portfolio at a pharmaceutical manufacturing site; Use of RMMs in quality control: challenges and benefits; Rapid assay for bioburden and other contaminations; RMM Roundtable…

Raman Spectroscopy In-depth focus

Raman Spectroscopy: In-depth Focus 2015

22 October 2015

Identification of counterfeit drugs using dual laser handheld Raman; Low-frequency shift Raman spectroscopy of pharmaceutical respirable powders; Raman Roundtable

NIR Supplement

NIR in-depth focus 2015

3 September 2015

In this NIR in-depth focus: Challenges with NIR reflectance measurements of solid pharmaceuticals, Application of NIR spectroscopy in linking velocity profiles of a binary granular system…

Informatics Supplement

Informatics in-depth focus 2015

3 September 2015

In this Informatics in-depth focus: Informatics in 2025, Methods for the detection of drug-drug interactions in text & Computational approaches to mutagenicity assessments of impurities: in silico methods…

Microbiology in-depth focus 2015

Microbiology in-depth focus 2015

3 July 2015

In this in-depth focus: Diversity of bacteria in pharmaceutical water: significance and impact on quality, Risk-based environmental control and monitoring and Microbiology Roundtable…

PCR in-depth focus 2015

PCR in-depth focus 2015

3 July 2015

In this PCR in-depth focus: Mikael Kubista from TATAA Biocenter addresses biological heterogeneity with single cell profiling, a look at quantitative PCR in the assessment of novel hepatic cell models, plus Q&A with Bio-Rad’s Javier Alba…

Stem Cells Supplement

Stem Cells: In-depth focus 2015

20 April 2015

In this free-to-view stem cells in-depth focus, you can find out how computational (‘in silico’) methods can help to rationally choose bioactive small molecules to improve stem cell differentiation. The differentiation of pluripotent stem cells to hepatocyte-like cells is the focus of a second interesting article…

LC-MS Supplement

LC-MS: In-depth focus 2015

20 April 2015

In this free-to-view LC-MS in-depth focus, we delve into the world of glycans, and how their natural complexity necessitates sophisticated sequencing techniques, while another article aims to demonstrate the versatility of LC-MS and the ease with which it can be combined with a variety of MS systems, focusing particularly on nanoLC…

Near-infrared Spectroscopy (NIR) supplement

Near-Infrared Spectroscopy (NIR): In-depth focus 2015

19 February 2015

This free-to-view NIR in-depth focus reveals the fascinating evolution and future perspectives of near-infrared technology in the lively opening article, plus we examine the benefits of combining NIR spectroscopy with process analytical technology…

 

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