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Providing high quality content for the European pharmaceutical sector since 1996

Charles River has been working with EPR for a little bit less than 10 years now and we highly estimate the quality of service your company provides. We

sincerely appreciate your responsiveness, the evolutions of your services portfolio and the way you conduct scientific communication. We look forward to doing business with you for years to come and leverage the European scientific leadership.

MÉLANCOLIE SPEDITO-JOVIALBusiness & Marketing Manager, Microbial Solutions Charles River

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MUKESH KUMARManaging Director FDA Map

DAVIDELDERDirector, PTS GlaxoSmithKline

ANDREWTEASDALEPrinciple Scientist Astra Zeneca

MICHAELMILLERPresident Microbiology Consultants, LLC

MICHAELELLIOTTCEO Atrium Research & Development

SHERAZGULVice President & Head of Biology European ScreeningPort GmbH

MATTMORANDirector IBEC (PharmaChemical Ireland)

DONCLARKSenior Principal Scientist Pfizer GTS, UK

Advisory Board

Note From the EditorWith business deals, drugs R&D progress, manufacturing breakthroughs and regulations shaping the pharmaceutical industry, it is as thriving as ever. Its importance and far-reaching impact is reflected by the statistics: global pharma sales reached $1 trillion in 2014, according to the 2015 CMR Pharmaceutical R&D Factbook, which also forecasts that revenues will hit the $1.3 trillion mark by 2018. Meanwhile, Office of Health Economics figures, based on HM Customs and Excise data, reveal that in 2012, the pharmaceutical sector’s contribution to the balance of trade was the third greatest of nine

major industrial sectors, up from fifth in 1975.As Editor, I find it exciting to be at the forefront of pharmaceutical

developments, ensuring that those who engage with us have access to high-level and diverse content. While European Pharmaceutical Review magazine continues to flourish with engaging feature articles contributed by world-renowned pharma companies and top scientists, our digital platform is also growing, giving you access to the latest news, online-only articles, technical analyses and providing you with a platform to showcase whitepapers, videos and infographics. See all this and more at europeanpharmaceuticalreview.com.

Exciting things lie ahead in 2017. We’ve worked hard to determine the core topics that matter most to the industry – subjects we’ll cover throughout the year. Of course, we shall also keep our fingers firmly on the pulse when it comes to publishing the latest ‘hot topics’ and trends as and when they happen. And European Pharmaceutical Review’s successful series of events, conferences and webinars will continue to bring the industry together to discuss trends and key topics in detail.

Partnering with European Pharmaceutical Review will help you reach the right people at the right level and at the right time. We all look forward to working with you over the next year.

STEVE BREMER [email protected]

A global network of highly respected leaders in their specialist fields who continuously compile and advise our teams on curating the highest quality content for our international audience.

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BY JO

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Reach over 84,340 Pharmaceutical and Bio Pharmaceutical professionals involved in the formulation, development and delivery of drugs across a range of media channels

Our Members

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Lab Management7%

I’ve worked with European Pharmaceutical Review for the past five years on a number of varied projects. I’ve always found them extremely responsive in designing and

presenting the optimal package to meet my desired objectives and flexible in their approach when timelines or our approach changes. In addition, they offer an excellent and large database of contacts in our target markets which can also be geographically segmented.

DR TIM CROSS EMEA Regional Marketing Manager - HPLC, Chromatography and Mass Spectrometry Thermo Fisher Scientific

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European Pharmaceutical Review is published bi-monthly and has an ABC audited worldwide circulation of 11,999 PLUS our online magazine adds an additional unique 6,606 readers.

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Two-dimensional liquid chromatography (2D-LC) has gained popularity over the past 20 years. Naja Wessel Jacobsen and Lars Dencker Nielsen, from Leo Pharma, explain how they use an MHC 2D-LC system in their analytical troubleshooting laboratory and how it can be applied to solve key tasks in the lab.

Guidance for mutagenic impurities has necessitated control of these toxic impurities at very low levels in APIs. Dave Elder explores the use of various techniques, such as counter current chromatography, organic solvent nanofiltration, and molecular imprinted polymers, to tackle the issue.

SEPARATIONS & PURIFICATIONS These special bound in supplements offers companies

the opportunity to align themselves against key topics, within the drug development and production arena.Not only are they part of the print magazine, but are accessible via europeanpharmaceuticalreview.com, and marketed via our weekly e-newsletters as well as being promoted to our whole database.The In-Depth Focuses offer a select number of sponsors a platform, for brand awareness, thought leadership as well has lead generation.

In-Depth Focus

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ISSUE 1 ISSUE 2 ISSUE 3 ISSUE 5ISSUE 4 ISSUE 6FEB APR JUN OCTAUG DEC

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Guide to QA/QC Instrumentation Guide to Drug Delivery Guide to Testing Services Guide to API’s, Excipients

and Fine Chemicals Guide to Outsourcing

THE GUIDE TO...

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Ensure your aseptic and shelf-stable products are free of contamination days faster than traditional methods with Celsis® and Accugenix® products and services. Quick time to market saves you time and money. You can count on us to deliver valuable, innovative tools that improve your operations and manufacturing efficiency. Learn more at www.criver.com/micro.

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A comprehensive portfolio of leading products and servicesThe Charles River Microbial Group delivers the industry’s most comprehensive portfolio of leading micro QC products and services. The three industry-leading brands – Endosafe®, Accugenix® and Celsis® – create an expansive, unifi ed, set of core competencies that meet the diverse testing needs of the biopharmaceutical, medical device, compound pharmacy, home, beauty, dairy, beverage, and food industries.

MORE than a solutions provider, Charles River defi ne themselves as a collaborative partner that develops new systems and services to revolutionise QC methods and capabilities.

Their objective is to keep their customers’ manufacturing operations running effi ciently and smoothly, lower costs to manufacture, and protect customers’ reputations.

What are the main challenges that the pharmaceutical sector faces in testing for QA/QC?Regulations change, budgets tighten, and timelines shift unexpectedly, so tests need to be faster, more adapted and cost effective, but with greater accuracy and reliability of results. Having to repeat tests and wait extended periods of time for results are causing delays to production and critical decisions.

What are the main areas that you can test for?Charles River Microbial group offer a unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identifi cation and strain typing. They all deliver the rapid, accurate and reliable data that the pharma industry needs to fuel quick decisions on product quality for release.

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What additional services do you provide? Charles River Microbial Solutions not only comply with stringent quality practices, but also provide guidance for their products and services, to satisfy all insourcing and outsourcing needs. They provide support with methods’ development, analysis, internal audit with the profi ciency testing programmes, SOP-writing assistance, tracking and trending tools for data, and also for the Charles River Cortex data management system.

What are the additional benefi ts to working with you?Rapid, reliable data are necessary to identify problems earlier, release products faster, streamline the supply chain,

COMPANY DETAILSEMAIL: [email protected]: feelingthepressure.criver.com

Ensure your aseptic and shelf-stable products are free of contamination days faster than traditional methods with Celsis® and Accugenix® products and services. Quick time to market saves you time and money. You can count on us to deliver valuable, innovative tools that improve your operations and manufacturing efficiency. Learn more at www.criver.com/micro.

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and avoid costly retesting – all without sacrifi cing product quality. Charles River’s advanced solutions for rapid endotoxin testing, microbial detection, and microbial identifi cation, provide reliable and consistent results.

The trend in the pharmaceutical industry is to globalise testing services. How can your company address the local needs of users?Product demand seems to be expanding globally. The different stakeholders need support and solutions from a collaborative, fl exible partner – in their own time zones and languages. They need ultimate accessibility. With 101 countries, 46 languages, 24 time zones and 12 different industries, comprehensive solutions and support services, the Microbial team raise the bar of personal assistance, from the very fi rst conversation to the delivery of service and beyond.

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Ralph O. Schoenleber on peptidesEuropean Pharmaceutical Review Editor, Steve Bremer, discusses peptide research and the manufacture and development of glycosylated peptides with Ralph O. Schoenleber, PhD, VP Research and Development at Bachem AG.

Which current area of research at Bachem do you think is the most exciting, or likely to have the biggest impact on pharmaceutical research and development?Internal research projects at Bachem are primarily targeted to result in long-term commercial benefi t. The continuous investment in development and implementation of new chemistries and technologies is regarded as crucial for future success. This is especially the case since stringent and costly requirements from authorities and the demand for more complex structures from clients require major efforts to remain competitive.

In particular, the increasing interest in longer and signifi cantly more complex peptides and peptide conjugates represents a challenge for all peptide manufacturers. Unlike biotechnological production, the synthetic access to these macromolecules allows for substantial fi ne-tuning of these structures. Therefore, products with tailored properties can be developed, offering opportunities to achieve patent protection for the optimised structures.

What advantages does your chemical glycosylation of peptides give to drug developers?Glycosylation of peptide drugs can be a powerful way to enable optimisation of lead candidates. Chemical glycosylation permits the synthesis of peptides and proteins with pre-attached sugars. It has been shown to markedly improve drug properties such as half-life, binding affi nity and selectivity. Furthermore, compared to recombinant products, the chemically synthesised proteins

are more homogeneous. Selective, site-specifi c glycosylation leads to a homogeneous product with potential for more defi ned bioactivity compared to heterogeneous products.

What technological challenges are presented by the synthesis of longer and more complex peptides, and how are you overcoming these?Enhanced interest in long peptides, and even synthetic proteins, is a logical consequence of the development in biology and chemistry. In particular, progress in mass spectrometric techniques has facilitated the discovery of more complex peptides. As considerable progress in synthesis and ligation technologies has been realised, these molecules are well within the scope of current synthetic methodologies. Bachem’s research projects originate from the idea to continuously evaluate new chemistries and technologies to improve on existing processes in a dynamic fashion. Collaborations with external research partners like Prof S Kent complement these activities.

Can you summarise the key aspects of your ground-breaking and award-winning work on Interferon b-1a, and how this has been taken forward by other researchers?The partnership between Bachem and GlyTech is focused on the chemical development and manufacturing of glycosylated peptides. Bachem has the proven expertise to scale up and manufacture peptides at all volumes required, while GlyTech is capable of producing glycans in kilogram amounts by a proprietary technology. Bachem and GlyTech were the 2013 CPhI innovation prize fi nalist for their work on Interferon b-1a.

The selective chemical glycosylation has potential to be applied to a variety of peptides, owing to the concept of

Ralph O. Schoenleber, Bachem AG

www.bachem.com

improving current and future drugs via chemical glycosylation. For a lead peptide, which has been chosen for glycosylation, a library of over 50 specifi c human-type glycans is available. This technology has been used in several other projects, such as to manufacture glycosylated somatostatin analogues and glycosylated GLP-1. In all cases, drug improvements were achieved. Some of the glycopeptides emanating from the partnership are now in clinical trials.

What might the future hold for peptide research?For a contract manufacturing organisation in the competitive environment of pharma and biotechnology, research and development is extremely important to enhance customer satisfaction and service quality. Increasing demands on performance, combined with growing sustainability requirements, such as those relating to occupational safety as well as waste management, are chief concerns of our markets. There is a trend towards the development of molecules with higher complexity and, at the same time, the patent landscape is more and more crowded. Plus, requirements from customers and authorities with regard to documentation – and data integrity in particular – are changing the way people work.

In order to meet the increasing demands of the markets, a company needs the right combination of creative, innovative – but at the same time structured and accurately working – scientists on board, and they need to focus on the management of knowledge as a key factor to success. Efforts on knowledge management at Bachem focus on organisational objectives, such as continuous improvement, competitive advantage, innovation, and the sharing of ‘lessons learned’.

UNDER TH E MI CRO SCO PE | BACHEM AG

CHEMICAL GLYCOSYLATIONOF PEPTIDESBACHEM

Bachem and GlyTech, Inc.Two pioneers in their respective fieldscollaborating to advance innovation in drug development.

ADVANTAGES OF CHEMICAL GLYCOSYLATION

• Homogeneous products: chemical synthesis yieldswell-definedglycopeptides

• Most chemically synthesized peptide drugs can be easily adapted to glycosylation

• Competitive production costs

Improving the Pharmacokinetic Profile of Drugs

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H3C

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www.bachem.com

MORE THAN 50 GLYCANS ARE AVAILABLE

European Pharmaceutical Review’s exclusive Editor Interview, offers the opportunity for a key industry figure from your company or one of your customers, to speak exclusively about pressing topics within the industry.

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72 European Pharmaceutical Review VOLUME 21 ISSUE 2 2016

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72 European Pharmaceutical Review VOLUME 21 ISSUE 2 2016

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IntroductionThe U.S. FDA’s Quality by Design (QbD) and Process AnalyticalTechnology (PAT) initiatives encourage the pharmaceutical industry toadopt risk-based manufacturing approaches. Real-time PAT monitoringof pharmaceutical unit operations enables Quality by Design andimproves process robustness. Raman spectroscopy is uniquely suited asa PAT tool because it can acquire data directly from the process line inreal-time and with little or no sample preparation, often without a needfor the probe to come into contact with the sample. The utility ofRaman for in-line, real-time process monitoring and control isdemonstrated for content uniformity. In this application, in-line, non-invasive Raman spectroscopy was used to monitor blended granuleuniformity prior to tablet compression.

ExperimentalRaman measurements were obtained during process-validation runswith a RAMANRXNTM analyser utilising PhAT technology from KaiserOptical Systems. A non-contact Raman PhAT probe (785nm, 6mm spotsize, 250mm focal length) mounted onto a Teflon holder was used tomonitor the blended granule uniformity just upstream from the tabletpress. The Raman probe analysed granule samples of approximately 140mg which correlates closely to the standard dosage unit of 160mg. Raman data were recorded continuously with a 30s exposuretime and two accumulations. The mean square of differences (MSD)between two consecutive spectra was used to identify the time requiredto obtain a homogeneous mixture. The predicted quantitative blenduniformity was determined by Raman analysis of laboratory samplesusing a two-component partial leastsquares (PLS1) calibration model(RMSEC = 0.43, RMSECV = 0.52). Raman measurements were alsocollected during tablet compression.

ResultsRaman spectroscopy was used to monitor granule homogeneity at thefeed frame of the tablet press, which is the last step before tabletcompression1. High-performance liquid chromatography (HPLC) wasused as the standard assay method. Raman data of granule blenduniformity were compared with HPLC data on tablet content uniformity.MSD profiles indicated that a homogeneous mixture was obtained afterabout 15 minutes of blending, which was confirmed by HPLC. Raman-predicted %API was 3.13% (RSD = 2.38%) using a multivariate calibrationmodel during continuous tablet compression. This correlates well withthe nominal concentration of API (3.125%) in the blend.

Granule blend uniformity and tablet content uniformity werecorrelated by sampling time and were found to be in good agreement.For example, Raman analysis of granule blend uniformity shows 100.5%mean potency (RSD = 2.3%), and HPLC analysis of tablet contentuniformity at 40% tablet compression shows 103.2% mean potency

(RSD = 1.2%). The relative standard deviation for blended granuleuniformity by Raman was somewhat higher (2–3%) than that for cont-ent uniformity by HPLC (1–2%). The slightly higher RSD from Raman mayarise from different sample sizes, effective API concentrations, orpresence of excipients and granule optical properties.

ConclusionThis study demonstrates that Raman spectroscopy can be successfullyimplemented as an in-line monitoring tool for pharmaceutical blendingprocesses and tablet compression. The RAMANRXN analyser permitsreal-time monitoring of pharmaceutical unit operations with little or nosample preparation. In-line Raman utilising PhAT technology provides aquality output that compares favorably with off-line QC testing butenables real-time process corrections, such as a longer blend time, thatare not possible with off-line QC testing such as HPLC or transmissionRaman. The results also indicate that Raman spectroscopy isappropriate for monitoring and control of continuous processing andreal-time release testing.

KAISER OPTICAL SYSTEMS INC. Application Note

In-line Raman spectroscopyfor content uniformityRaman monitoring of blended granule uniformity prior to tablet press

30 European Pharmaceutical Review Application Notes & Whitepapers 2015 www.europeanpharmaceuticalreview.com

Further information:Kaiser Optical Systems, Inc.www.kosi.com

Figure 1: Predicted content of API in granules during tablet compression (nominalvalue is 3.125%). Raman data also enabled identification of the compression starttime and end time, and continuous and non-continuous compression time periods.1© 2006 Russell Publishing.

1. Jayawickrama, D. et al. “Raman Applications in Drug Manufacturing Processes.” Am.Pharm. Rev., November/December 2006, 10–17.

Data kindly provided by Dimuthu Jayawickrama, Arwa El Hagrasy and Shih-Ying Chang,Bristol-Meyers Squibb Co.

Reference

Acknowledgments

epr615 Kaiser App Note_Layout 1 09/12/2015 15:41 Page 1

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• Shawn Shafer, PhD, Advanced Genomics Market Segment Manager, MilliporeSigma, a business of Merck KGaA, Darmstadt, Germany

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TOTAL REGISTRATIONS: 426

WEBINAR CASE STUDY

• Use the webinar as a platform to launch new products and services

• Ensure that your company is front of mind when buying decisions are taken

• Connect and engage with your target audience

• Differentiate yourself from competitors with strong brand presence

• Demonstrate thought leadership in front of heads of industry

Increase your brand profile and share your capabilities and experience with a captive audience of leading industry professionals

• Foster loyalty with existing clients

• Grow your audience with increased reach, impact and accessibility

• Transcend geographical boundaries

• Generate new business

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European Pharmaceutical Review has been a partner of ours for many years. Our webinar campaigns always generate a significant

number of high quality leads which are relevant to our target audience. The attentiveness and support of their webinar team is second to none.

MEIKE HAMESTER, Director Small Molecule Pharma Business, Bruker Daltonics

great reasons to partner with us10 are generated on

average for every webinar

254 leads

£10,000

• Six-week marketing campaign:

• Four promotional e-Blasts (three before and one after the live webinar)

• Promotion across social media channels

• Full Page Preview in European Pharmaceutical Review

• Full Page Review in European Pharmaceutical Review

• Part of monthly content round up e-Blast

• Guidance provided throughout the project

• Webinar hosted live and on-demand

• Monthly reporting provided for three months following the live webinar

• Full details of everyone who registers to watch the webinar (live and on-demand)

FULL PACKAGE:

European Pharmaceutical Review webinars are the perfect platform to engage with numerous prospective customers, enabling you to target pharmaceutical and biotech companies, research institutes as well as academia whilst aligning your company with a topic of your choice. They are an extremely effective method of generating highly qualified leads, demonstrating your expertise and raising your profile through a comprehensive marketing campaign customised specifically for your needs.

+ VAT

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M EDIA P L A NN ER

January - June Content Calendar ISSUE 1

PRINT 9TH - PUBLISHED 16THISSUE 2


PRINT 22ND - PUBLISHED 29TH

JAN FEB MAR APR MAY JUN

• IFPAC 2017• Pittconn 2017• Interphex 2017

• HPLC 2017• BioProcess Europe 2017• Biotechnica 2017• Show Round Up 1

• Show Round Up 2

• Serialisation• Disease Research case study• 2017 Pipelines

• Nanotechnology• Veterinary• 2017 Pipelines

• Formulation• Disease Research case study• 2017 Pipelines

• Microbiology• 2017 Pipelines

• Biosimilars• Disease Research case study• 2017 Pipelines

• Safety by Design• 2017 Pipelines

• Environmental Monitoring • Formulation & development • HPLC/LCMS• Single-Use • Raman • Microbiology

• NIR• Biopharmaceutical Dev. &

Processing • Formulation Development &

Delivery

• Packaging• Pharmaceutical Microbiology• Mass Spectrometry

• Raman• Separations & Purifications• Formulation Development &

Delivery

• Guide to QA/QC Instrumentation • Guide to Drug Delivery • Guide to Testing Services

• PAT• Regulatory Insight• Law and Ethics• Celebrating 21 years of European

Pharmaceutical Review

• Dosage Forms• Regulatory Insight• Single Use• Celebrating 21 years of European


• RMMs• Regulatory Insight• Microfluidics• Celebrating 21 years of European


• HPLC 2017• ASMS 2017• CPhI North America 2017

• BioProcess Europe 2017 • Biotechnica 2017• Interphex 2017

ONLINE FEATURES

PRINT

BONUS DISTRIBUTION

DIGITAL

MONTHLY CONTENT E-NEWSLETTERS

IN-DEPTH FOCUS

SUPPLEMENTS

FEATURES

EVENT PREVIEWS


11

MEDIA PL ANNER

July to December Content Calendar ISSUE 4



PRINT 12TH - PUBLISHED 19TH

JUL AUG SEP OCT NOV DEC

ONLINE FEATURES

PRINT

BONUS DISTRIBUTION

• BioProcess International 2017

• ISPE 2017• CPHi World Wide 2017• AAPS 2017• Show Round Up 3

Anniversary Issue - Celebrating 21 years of European Pharmaceutical Review - guest edited

DIGITAL

• Bioprocessing• Disease Research case study• 2017 Pipelines• Top 10 Innovation

• Scale-Up• 2017 Pipelines

• Lab Automation• Disease Research case study• 2017 Pipelines

• PAT• Women in Pharma• 2017 Pipelines

• Big Data• Disease Research case study• 2017 Pipelines

• Drug Delivery• 2017 Pipelines

MONTHLY CONTENT E-NEWSLETTERS

• Outsourcing • Spectroscopy • Drug Delivery • Chromatography • Bioprocessing • RMM

IN-DEPTH FOCUS

• Environmental Monitoring• Biopharmaceutical Dev. &

Processing • Quality Control/Quality Assurance

• Separations & Purifications• Pharmaceutical Microbiology• Ingredients

• Raman• Formulation Development &

Delivery• Biopharmaceutical Dev. &

Processing

SUPPLEMENTS• Guide to API’s, Excipients

and Fine Chemicals • Guide to Outsourcing • App Note& White Paper Supp

FEATURES

• Market Access• Regulatory Insight• Freeze drying• Celebrating 21 years of European


• Continuous Manufacturing• Regulatory Insight• Laboratory Informatics• Celebrating 21 years of European


• Particle Sizing• Regulatory Insight• Oncology• Celebrating 21 years of European


EVENT PREVIEWS

• AAPS 2017 • Pittcon 2017• CPHi World Wide 2017• BioProcess International 2017• ISPE 2017

• Show Round Up 4

Ryan ClarkeSales Executive

T: +44 (0)1959 563311 | M: +44 (0)7725 645518E: [email protected]

Steve BremerManaging Editor

T: +44 (0)1959 563311E: [email protected]

Niamh MarriottJunior Editor


Rizwan ChaudhreySales Director


Nic LosardoPublisher



Ryan ClarkeSales Executive


Steve BremerManaging Editor


Niamh MarriottJunior Editor


Rizwan ChaudhreySales Director


Nic LosardoPublisher


MEDIA PLANNER - European Pharmaceutical Review · Providing high quality content for the European pharmaceutical ... MEDIA PLANNER Global Reach BY JOB BUSINESS ... 2016 Client Survey

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