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Issue #2 2016

Here’s a summary of what you’ll find in the next issue of European Pharmaceutical Review:

MASS SPECTROMETRY IN-DEPTH FOCUS

  • The use of mass spectrometry for the characterisation of proteins in small molecule drug discovery
    Rick A. Davies, Melanie Snow, Jonathan Renshaw, AstraZeneca
  • Novel trends in glycosylation analysis of biotherapeutics by mass spectrometry
    Pilsoo Kang and Jianmei Kochling, Sanofi and Hanjo Lim, Genentech

SINGLE USE IN-DEPTH FOCUS

  • Managing the quality of biologics manufactured by single-use systems: A Japanese perspective
    Akiko Ishii-Watabe and Akihiko Hirose, National Institute of Health Sciences, Sei Murakami, Hitachi, Takehiro Okumura, Takeda Pharmaceutical, Hiroyuki Matsuda, Fujimori Kogyo and Daisuke Kajihara, GE Healthcare Japan Corporation
  • Disposables for continuous viral clearance for the production of monoclonal antibodies
    Laura Holtmann and Martin Lobedann, Invite GmbH, Jorgen Magnus, Bayer and Gerhard Schembecker, TU Dortmund University

PAT SERIES

  • Exploring the advantages of PAT for pharmaceutical cleaning in Ireland
    Adeyinka Aina, University of Nottingham, Manuel Kuhs, Bernal Powder Engineering Research Group, Shaza Darwish, University of Limerick, Dr Chris Edlin, Pharmaceutical Technology Manufacturing Centre

MICROBIOLOGY SERIES

  • Novel approach in assessing the antimicrobial efficacy of eye drop products
    Mostafa Eissa, Hikma Pharmaceuticals

REGULATORY INSIGHT

  • CEIV Pharma: Industry cooperation that is taking off
    Ricardo Aitken and Michal Wielgus, IATA Consulting

ONCOLOGY

  • Inhibition of mutant P53 tumour cells by medicinal plants
    Osuntokun Oludare Temitope and Ogunleye Adewale Joseph, Adekunle Ajasin University

DRUG DELIVERY

  • Stem cell nano drug delivery applications to treat diabetes
    Vishal Shahidadpury, Anjali Hirani and Yashwant Pathak, University of South Florida Health

ROBOTICS

  • New trends in intelligent robotics in the laboratory
    Dr. Patrick Courtney, tec-connection

NANOTECHNOLOGY

  • Nanotechnology tackles problems with noninvasive glucose monitoring
    Andreas Thomas, Medtronic GmbH, and Araceli Ramírez and Alfred Zehe, Universidad Autónoma de Puebla

SHOW PREVIEWS

  • Analytica 2016 
  • HPLC

 

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Latest Issue

Latest Issue

 

European Pharmaceutical Review Issue #1 2016

Issue #1 2016 – Digital edition

Author(s): European Pharmaceutical Review

In this issue: Regulation, Drug Delivery, Raman, PAT, Formulation, NIR, Microbiology, and much more…

NIR In-depth focus 2016

NIR: In-Depth Focus 2016

Author(s): European Pharmaceutical Review

Moving to fast chemical imaging techniques in process control; Progress in nearinfrared techniques in biomedical research.

Raman In-depth focus 2016

Raman: In-Depth Focus 2016

Author(s): European Pharmaceutical Review

Raman as a valuable tool in high-throughput screening; Use of Raman in analysing polymorphism in pharmaceutical drugs; Upcoming Raman calibration standards; Raman roundtable

Dave Elder, GlaxoSmithKline and JPAG

Foreword: The evolving pharmacopoeia

Author(s): Dave Elder, GlaxoSmithKline and JPAG

Globalisation has facilitated greater international harmonisation and standardisation of quality standards, which in turn has impacted on pharmacopoeias. 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 Ignition (USP <281>) versus Sulphated Ash (Ph.Eur., 20414; JP, 2.4.44) . Similarly, pharmacopoeial monographs of active pharmaceutical ingredients (APIs) were developed primarily based on the input of the innovator and single sources of the API. In contrast, today’s monographs must reflect multi-source APIs from many generic suppliers, typically from India and China, rather than from Western Europe and the United States. Consequently, the test methods must be cheap, globally available and state-of the-art, but selective and robust – often a significant challenge…

Four trends that will transform healthcare in Europe in 2016

Four trends that will transform healthcare in Europe in 2016

Author(s): 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…

The role of drug transporters at the blood brain barrier

The role of drug transporters at the blood brain barrier

Author(s): 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 a physical, metabolic and immunologic barrier, the blood brain barrier (BBB), to protect it. The BBB comprises a very tight layer of capillary endothelial cells with elaborate tight junctions between adjacent cells that prevent most soluble materials from crossing, while allowing gases such as oxygen and carbon dioxide to diffuse through…

The application of skip testing to drug substance manufacture

The application of skip testing to drug substance manufacture

Author(s): 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 there is a low risk of any batches failing specification. In this article, a process is described (supported by an example) that could be followed to justify the use of skip testing. The process involves identifying attributes that are candidates for skip testing, performing a statistical evaluation to confirm there is a low risk of batch failure if skip testing is instigated and making ongoing assessments to confirm the process remains highly capable and the attribute(s) is predicted to be well within specification…

Dissolution testing in the modern world

Dissolution testing in the modern world

Author(s): Juliet Symonds and David Elder, GlaxoSmithKline

Historically, dissolution testing has been used primarily as a quality control (QC) test for solid oral drug products . 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 of bioequivalence testing. However, can the same dissolution test have enough robustness (as per 5 ) to be used as a routine QC tool, whilst simultaneously being sensitive enough to be truly bio-predictive? This article will explore this conundrum…

AT-Xtend offline with SAM-SR 300dpi

Expert View: Standardisation through automation

Author(s): 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 the products, equipment, and personnel associated with routine QC testing can be streamlined…

The challenges of riskbased environmental monitoring in sterile product filling

The challenges of riskbased environmental monitoring in sterile product filling

Author(s): James L. Drinkwater, Chairman, Pharmaceutical and Healthcare Sciences Society

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 analysis (FMEA) for determination of risk-based EM programs, considering aspects of the filling machine, barrier separation technology, surrounding cleanroom environment, monitoring methods/systems and process operations. The requirement for process monitoring for the manufacture of sterile medicinal products is starting to be discussed in the revision of EU GMP Annex 1, so as to bring together all EM data and hence consider the process holistically…

Feature-Upcoming-Raman-calibration-standards

Upcoming Raman calibration standards

Author(s): Kerstin Barr, Product Manager, Thermo Fisher Scientific

In this article, Kerstin Barr, Product Manager for handheld Raman instruments at Thermo Fisher Scientific, comments on the revised tolerances…

Past Issues

Supplements

Supplements & Special Editions

 

NIR In-depth focus 2016

NIR: In-Depth Focus 2016

29 February 2016

Moving to fast chemical imaging techniques in process control; Progress in nearinfrared techniques in biomedical research.

Raman In-depth focus 2016

Raman: In-Depth Focus 2016

29 February 2016

Raman as a valuable tool in high-throughput screening; Use of Raman in analysing polymorphism in pharmaceutical drugs; Upcoming Raman calibration standards; Raman roundtable

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…

Screening Supplement

Screening: In-depth focus 2014

5 January 2015

This free-to-view Screening In-Depth Focus is packed with articles that will give you a greater understanding of interesting topics such as the identification of compounds that protect against free radicals, advancements in sandwich immunoassay techniques and hit validation and optimisation…

PAT Supplement

PAT: In-depth focus 2014

5 January 2015

This PAT In-Depth focus explores current challenges posed by the slow uptake of Process Analytical Technology within the pharmaceutical and biopharmaceutical industries. The advantages of incorporating PAT into the pharmaceutical process are highlighted in two informative articles, and possible solutions to its lack of popularity surmised…

RMM in-depth focus

RMM: In-depth focus 2014

5 November 2014

Michael J. Miller discusses rapid microbiological methods and the regulatory environment, the Online Water Bioburden Analyzer Workgroup look at the path to implementing Online Water Bioburden Analyzers, plus RMM roundtable…

Raman Spectroscopy in-depth focus

Raman Spectroscopy: In-depth focus 2014

5 November 2014

Sulaf Assi discusses the investigation of medicine quality using handheld Raman spectroscopy, a look at Raman hyperspectral imaging, plus Raman roundtable…

NIR Supplement - 100

NIR: In-depth focus 2014

5 September 2014

In this free-to-view NIR in-depth focus: Moving towards continuous manufacturing with NIRS and NIR-CI systems, Monitoring of pharmaceutical powder mixing by NIR spectroscopy

Informatics Supplement

Informatics: In-depth focus 2014

5 September 2014

In this free-to-view Informatics in-depth focus: Reviewing the roles and opportunities for informatics in pharmacovigilance, Laboratory informatics: a wind of change?

Microbiology Supplement 2014

Microbiology: In-depth focus 2014

3 July 2014

In this free-to-view in-depth focus: How to deal with non-sterile results in aseptic processing, Risk Profiling and Proactive Response (RPPR) to Bio-contamination in GMP classified and controlled areas, Microbiology Roundtable…

qPCR Supplement

qPCR: In-depth focus 2014

3 July 2014

In this free-to-view in-depth focus: Prime time for qPCR – raising the quality bar, PCR to diagnose infectious disease, plus qPCR Roundtable…

Stem Cells In-depth Focus

Stem Cells: In-depth focus 2014

15 April 2014

In this free-to-view in-depth focus: Mesenchymal stem cells in cancer therapy – our chance to take charge, and Ovarian cancer stem cells – an essential target for durable remission…

Mass Spectrometry In-depth focus

Mass Spectrometry: In-depth focus 2014

15 April 2014

In this free-to-view in-depth focus: Some tricks and tools for structural characterisation of natural products using Electrospray mass spectrometry, Mass spectrometry in the biopharmaceutical industry: from the mundane to the cutting edge, and Mass Spectrometry roundtable…

Raman Spectroscopy Supplement - 100

Raman Spectroscopy: In-depth focus 2014

10 April 2014

Raman spectroscopy in the study of pharmaceuticals: the problems and solutions to sub-sampling and data analysis
Conformational state analysis of proteins by Raman spectroscopy: univariate and multivariate methods
Raman Roundtable

Near infrared spectroscopy (NIR) Supplement

Near Infrared Spectroscopy: In-depth focus 2014

9 April 2014

Near infrared light spectroscopy: Applicability and new developments
Near infrared spectroscopy: in-line biopharmaceutical Chinese Hamster Ovary cell culture monitoring

EPR Screening Supplement 2013 - 100

Screening: In-depth focus 2013

16 December 2013

Technological and sociological advances in HTS: evolution and revolution?
Flow cytometry as a drug screening platform
Show Preview: High-Content Analysis 2014

PAT Supplement 2013

Process Analytical Technology (PAT): In-depth focus 2013

16 December 2013

Presenting a rational approach to QbD-based pharmaceutical development: A roller compaction case study
PAT for pharmaceutical spray drying
PAT Roundtable
Show Preview: IFPAC® 2014

PCR Supplement 2013

PCR: In-depth focus 2013

25 October 2013

Challenges for qRT-PCR in detecting / quantifying microRNA in vitro and in vivo.
Emerging clinical applications of digital PCR.
Workshop Preview: Advanced 3d cell based assays, preparation, analysis and troubleshooting.

Raman Supplement 2013 - 100

Raman spectroscopy: In-depth focus 2013

25 October 2013

Raw material identification using dual laser handheld Raman spectroscopy.
Raman spectroscopy in support of biotherapeutic production: applications in protein formulation and purification
Raman Spectroscopy Roundtable.

EPR Informatics Supplement 2013

Informatics: In-depth focus 2013

21 August 2013

Using LIMS for biobanking and implementing LIMS for research.
Biologics development and ELN: A good match?
Informatics Roundtable.

RMMs & Environmental Monitoring Supplement 2013 - 100

RMMs & Environmental Monitoring: In-depth focus 2013

21 August 2013

The rapid microbiological methods revolution.
Controlling contamination in the pharmaceutical industry.
Rapid Micro Methods Roundtable.

Screening Supplement 2013 - 100

Screening: In-depth focus 2013

30 July 2013

New approaches to cell based assays for high content screening and analysis.
Reduce, reuse, recycle: how drug repositioning is finding its niche in drug discovery.
Workshop Review: Biochemical assays for screening.
Screening roundtable.

Ingredients Supplement 2013 - 100

Ingredients: In-depth focus 2013

13 June 2013

Revisiting a mutual recognition agreement approach for GMP inspections to secure the safety of the supply chain of APIs.
Solid form diversity of commonly used tableting excipients and its impact.

Mass Spectrometry Supplement 2013

Mass Spectrometry: In-depth focus 2013

17 April 2013

Corticosteroids and mass spectrometry; latest applications using LC/MS3.
Multi-analyte LC-MS/MS assays for the quantification of endogenous compounds during the development of drugs and companion diagnostics…

Stem Cells Supplement 2013

Stem Cells: In-depth focus 2013

17 April 2013

The promise held by induced pluripotent stem cells for research and regenerative medicine.
Workshop preview – Cell based assays for screening.
Cardiac stem cells.
Stem Cells Roundtable.

Near Infrared (NIR) In-deptch focus 2013

Near Infrared Spectroscopy: In-depth focus 2013

18 February 2013

Validation methodologies of near infrared spectroscopy methods in pharmaceutical applications.
Evaluating the influence of hopper geometry on radial and axial concentration profiles in flowing granular mixtures.

Manufacturing & Packaging Supplement 2013

Pharmaceutical Manufacturing & Packaging: In-depth focus 2013

18 February 2013

The chemical safety assessment process for extractables and leachables associated with packaged pharmaceutical products.
INTERPHEX 2013: Show preview

Drug Targets Supplement 2012

Drug Targets: In-depth focus 2012

11 December 2012

GPCR allosteric modulation: new opportunities and challenges for drug discovery.
Chloride channels and cardiac arrhythmia: novel therapeutic targets?

qPCR Supplement 2012

qPCR: In-depth focus 2012

24 October 2012

Setting the bar.
Q & A – Mikael Kubista from the TATAA Biocenter poses five questions for Jay Brock, Senior Manager, Applications and Technical Support, USB® Life Science Reagents from Affymetrix.
Not your grandfathers’ real-time PCR.

Raman Supplement 2012

Non-destructive material identification: In-depth focus 2012

24 October 2012

An implementation perspective on handheld Raman spectrometers for the verification of material identity.
Portable Raman spectroscopy for pharmaceutical counterfeit detection.
Ask the Experts.

Microbiology-Series-2012-Part-1-100

Microbiology Series 2012 – Part 1

24 September 2012

How the acceptance of rapid microbiological methods (RMMs) continues to be hampered by misconceptions, misunderstandings and myths.
Rapid micro methods and EMA’s post approval change management protocol.
Rapid sterility testing and the impact of recent changes to the US Code of Federal Regulations.

Informatics In-depth focus 2012

Informatics – In-depth focus 2012

2 September 2012

Developing Informatics for the pharmaceutical industry.
Rolling out a biology ELN at UCB Pharma.
Ask the Informatics experts.
Laboratory Informatics – Out of the fog and into the cloud?

PAT Supplement 2012

In-depth focus – Process Analytical Technology (PAT)

6 July 2012

Process analytics experiences in biopharmaceutical manufacturing.
Correlation between powder rheology data and processability in solid dosage form manufacturing.
Expert industry users of process analytical technologies for pharmaceuticals pose questions for leading vendor experts of process analytical technology.

Stem Cells Supplement 2012

In-depth focus – Stem Cells

5 July 2012

Stem cell therapies: Assuring safety.
Role of pluripotent stem cells in neurotoxicology testing: Impacts and applied innovations.

In-Depth Focus: Mass Spectrometry

In-depth focus – Mass Spectrometry

25 April 2012

Mass spectrometry in drug discovery – Proteomics, small molecules and metablomics.
Quantification of membrane drug transporters and application in drug discovery and development.
Mass spectrometry leaders roundtable.

Near Infrared Supplement 2012

Near Infrared supplement 2012

27 February 2012

Understanding external factor influences and the right use of chemometrics.
Recent advances in spectroscopic measurements applied to pharmaceutical testing.
Discover what vendor companies are discussing in our Near Infrared Spectroscopy Leaders Roundtable.

PAT Supplement 2011 Front Cover

PAT supplement 2011

15 December 2011

The historical development of the FDA’s PAT initiative and its present course.
Implementation of modelling approaches in the QbD framework: Examples from the Novartis experience.
Challenges in development and implementation of spectroscopic techniques as PAT Analysers.

Rapid Methods Supplement 2011

Rapid Methods supplement 2011

24 October 2011

A regulators view.
Microbiology series: Nucleic acid and gene amplification-based technologies.
Challenges and strategies for application in the pharmaceutical industry.

Raman Supplement 2011

Raman supplement 2011

24 October 2011

Solid state transformations of APIS during manufacturing by Raman analysis of pharmaceutical molecules and dosage forms.
Detection, determination of chemical composition and chemical profiling of counterfeit medicines.

Genomics Sequencing supplement

Genomics / Sequencing supplement 2011

31 August 2011

NGS powers up drug discovery and healthcare.
Impact of novel sequencing technology on transcriptome analysis.
Making sense of nonesense (and missense): Bringing the results of recent genetic studies into the drug discovery laboratory.

eLN supplement

eLN supplement 2011

31 August 2011

Introduction: eLNs – An essential productivity tool – but which one to use?
Using an eLN to create GMP compliant records for drug substance manufacture.
Implementation of an electronic lab notebook system at VIB.
eLN sponsors roundtable (featuring Accelrys, IDBS, AgileBio, Agilent, LabWare Europe, Waters).

 

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