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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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VOLUME 21 ISSUE 1 2016 European Pharmaceutical Review 1

2 Raman: a valuable tool inhigh-throughput screening Nikolaos Scoutaris, University of Greenwich

6 Use of Raman in analysing polymorphism in pharmaceutical drugs Ye Ying, Shanghai Normal University, Anna Łuczak, Bristol Myers Squibb and Zafar Iqbal, New Jersey Institute of Technology

12 Raman Roundtable Moderated by Zafar Iqbal, New Jersey Institute of Technology

Raman

© A

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at /

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ters

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SPONSORS

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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72 European Pharmaceutical Review VOLUME 21 ISSUE 2 2016

THE GUIDE TO...

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THE GUIDE TO...

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COMPANYLOGO

COMPANY FACTS

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YOUR ADVERT HERE

ISSUE 1 ISSUE 2 ISSUE 3 ISSUE 5ISSUE 4

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Guide to QA/QC Instrumentation Guide to Drug Delivery Guide to Testing Services Guide to Ingredients Guide to Outsourcing

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Which stages of the drug development process can effectively be outsourced to contract service providers such as yours?Eurofins BioPharma Product Testing provides scientific support servicesthroughout all stages of the drug development process, from preclinicaland clinical studies to commercialisation. The reality is that outsourcingstrategies continue to evolve, and there is a continuum from verytactical approaches to address discrete needs, to wholesaleoutsourcing of complete programs. I expect this will continue to be thecase for many years to come as it simply makes sense to have thisflexibility, depending on whether a target entity is being developed in-house or is fully outsourced.

We have designed our operations and offerings to effectively servethis continuum of needs. We want to be highly effective for ourcustomers regardless of whether they have a discrete need, or arelooking to hand over all aspects of a full development program, or are supplementing their in-house quality control operations. We havedeveloped the most comprehensive offering of large and smallmolecule testing services in the industry and all manner of develop -ment, manufacturing and process support.

You have a large global footprint. Can you tell me what the benefits of such a wide network of labs are and what your future plans are?There is an interesting dynamic in contract testing for the biopharmaindustry in that there is a dichotomy in terms of very local/regionaltesting activity, versus global/international activity where the testingsite is less important. We have built the Eurofins BioPharma ProductTesting platform to effectively address both needs. With 22 laboratoriesworldwide (17 in Europe), we have the regional presence and expertiseto provide testing services to local manufacturing and developmentsites, and the geographic reach to support global manufacturers anddevelopment organisations with needs at multiple sites and in multiplemarkets. Essentially, we are where our clients need us to be.

Our network has grown both organically and through acquisitions.Recently, we added Sinensis Life Sciences in the Netherlands and amsLaboratories in Australia, increasing our geographical reach as well asproviding new service offerings, such as aseptic manufacturing servicesand GMP nuclear magnetic resonance services. And we will continue todrive opportunities that add specialised services and further

geographic expansion. We also invest heavily in existing facilities, withrecent expansions to our labs in Paris, Milan and Uppsala, and activeexpansions in the US, Ireland and Munich.

Is it more important to invest in improving existing lab equipment and add existing services, or to attain geographical growth? I think our customers really expect both from us. Our objective is togrow and mirror our customers in every way that adds value to them.This has driven expansion to new services, to developing the mostcomprehensive testing capabilities available in the industry, and tofurther expanding the largest global network of GMP laboratories. One of the many things I really appreciate about Eurofins is theabsolute commitment to aggressively funding growth to serve ourcustomers. This enables us to really be that one stop global partner.

How can you ensure that the same high level of quality is achieved across your laboratories?It is imperative that we serve our global clients with consistency acrossall 22 locations, and we have gone to great lengths to harmonise oursystems to achieve this. We have global quality policies and a uniform CAPA/Exceptions Management System to deliver consistency in testing and quality across our network. We have invested greatly in harmonising LIMS, as well as our online data access portal,LabAccess.com, to deliver access to results, raw data and evenscientists’ notebooks in real time. Simply put, we want our laboratoriesto be fully transparent.

What mechanisms are in place to ensure that contractservice providers can be monitored and reviewed?Effective monitoring of contract service providers has gained hugevisibility and importance for bio/pharmaceutical companies due to the pressures being placed on them by regulatory agencies. To addressthis and fully support our customers in this vital responsibility, Eurofins has developed a suite of deliverables to fulfil this expectation.These include detailed metrics reporting and other supportingdocumenta tion to enable sponsors to effectively respond to regulators.We believe this is our responsibility, and a key part of delivering a great service, making us easy to work with, and making us the partnerof choice.

UNDER THE MICROSCOPE


Dr. Timothy S. Oostdyk, Group Senior Vice President ofEurofins BioPharma Product Testing, discusses the issuesaffecting outsourcing to the biopharmaceutical industryand the benefits of having a wide global reach.

epr216 Eurofins UTM_Layout 1 26/04/2016 13:55 Page 1

With the largest network of harmonized bio/pharmaceutical GMP product testing labs worldwide, Eurofins BioPharma Product Testing is everywhere you are.

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Facerci anditae perrovi tatate rem re ne conet quodi dolor mo voluptusti verehentis erum?Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur, corporem quam quaspi. Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut ea sequam duciatur, corporem quam quaspi. Sum aut officipiet aut restiis quos unt offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur, corporem quam quaspi. Sum aut officipiet aut restiis quos unt a quate

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et evendi reius di odipsan issum, tempor as elibeaquam runturitior.

Voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut of-fic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur ace-pro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur, cor-porem quam quaspi. Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, vo-luptae dolorerspel iust quae re verovid emo-lut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tene-cabore, corem ut ipsam nus secus res et om-nimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur.

Corporem quam quaspi. Sum aut of-ficipiet aut restiis quos unt a quate et ev-endi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quis-quam de venetur se sam voluptatio dempo-rumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitempor as elibeaquam, volup-tae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea se-quam duciatur, corporem quam quaspi.

Facerci anditae perrovi tatate rem re ne conet quodi dolor mo voluptusti verehentis erum?Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes

sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur, corporem quam quaspis.

Facerci anditae perrovi tatate rem re ne conet quodi dolor mo voluptusti verehentis erum?Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo e dolorerspel iust quae re verovid emolut acculpa volo e dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur volorum quides rem. Itassi cor aut re ea sequam duciatur, corporem quam quaspis si inciam alit volut quidebi sciam, que quiam sa voluptis ducimus ciassit, adistem utaspeliquam runturitior. Voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur, corporem quam quaspi. Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur.

Voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quis-quam de venetur se sam voluptatio dempo-rumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur

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ra non porepreped quatur sum necturi ora-tur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur, corporem quam quaspi. Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, vo-luptae dolorerspel iust quae re verovid emo-lut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea se-quam duciatur, corporem quam quaspi.

Tatate rem re ne conet quodi dolor mo voluptusti verehentis erum?Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur, corporem quam quaspi. Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis

Facerci anditae perrovi tatate rem re ne conet quodi dolor mo voluptusti verehentis erum?Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur, corporem quam quaspi. Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut.

Lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea se-quam duciatur, corporem quam quaspi. Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo offi-cid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis

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ASK THE EXPERT

vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur, corporem quam quaspi.

Facerci anditae perrovi tatate rem re ne conet quodi dolor mo voluptusti verehentis erum?Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur, corporem quam quaspi. Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut ea sequam duciatur, corporem quam quaspi. Sum aut officipiet aut restiis quos unt offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur, corporem quam quaspi. Sum aut officipiet aut restiis quos unt a quate

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et evendi reius di odipsan issum, tempor as elibeaquam runturitior.

Voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut of-fic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur ace-pro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur, cor-porem quam quaspi. Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, vo-luptae dolorerspel iust quae re verovid emo-lut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tene-cabore, corem ut ipsam nus secus res et om-nimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur.

Corporem quam quaspi. Sum aut of-ficipiet aut restiis quos unt a quate et ev-endi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quis-quam de venetur se sam voluptatio dempo-rumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitempor as elibeaquam, volup-tae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea se-quam duciatur, corporem quam quaspi.

Facerci anditae perrovi tatate rem re ne conet quodi dolor mo voluptusti verehentis erum?Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes

sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur, corporem quam quaspis.

Facerci anditae perrovi tatate rem re ne conet quodi dolor mo voluptusti verehentis erum?Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo e dolorerspel iust quae re verovid emolut acculpa volo e dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur volorum quides rem. Itassi cor aut re ea sequam duciatur, corporem quam quaspis si inciam alit volut quidebi sciam, que quiam sa voluptis ducimus ciassit, adistem utaspeliquam runturitior. Voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur, corporem quam quaspi. Sum aut officipiet aut restiis quos unt a quate et evendi reius di odipsan issum, tempor as elibeaquam, voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quisquam de venetur se sam voluptatio demporumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur acepro con nitam etuste volorum quides rem. Itassi cor aut re ea sequam duciatur.

Voluptae dolorerspel iust quae re verovid emolut acculpa volo officid quis-quam de venetur se sam voluptatio dempo-rumque odictint alis vellaut lab illes sollest ut offic tenecabore, corem ut ipsam nus secus res et omnimpe runturitior modis ra non porepreped quatur sum necturi oratur

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• Double Page Spread article (includes advertising space)• Posted online to our 19,441 unique monthly users• A PDF sent to you for your own marketing purposes • Promotion included in our weekly e-Newsletter • Promoted within an online company listing

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Bruker Optik GmbH

Rudolf-Plank-Str. 2776275 Ettlingen

Tel. +49 7243 504 2000 Fax. +49 7243 504 2050E-Mail: [email protected] us for more details www.bruker.com/bravo

Dedicated Raw Material AnalyzerBRAVO - A new era of Handheld Raman Spectroscopy

SSETM – Sequentially Shifted Excitation mitigates fl uorescence

Duo LASERTM provides the highest sensitivity throughout a large spectral range including the CH-stretching region

IntelliTipTM – automated recognition of measurement tips

Class 1M Laser safe in all modes of operation

Intuitive and guided touch screen operation

BRAVO makes Raman analysis accessible to everybody. New technologies especially designed for BRAVO provide an effi cient verifi cation of the widest range of materials. BRAVO supports the complete manufacturing process from raw material verifi cation to fi nished product inspection with functionality that meets your requirements.

RAMANInnovation with Integrity

“The Bruker BRAVO (Bruker RAman Verification Optics) opens a new erain handheld Raman spectroscopy because it addresses all of the so farpresent limitations,” says Armin Gembus, Global Business Unit Managerfor Raman and Gas Analytics at Bruker. “Patented Sequentially ShiftedExcitation (SSETM) technique takes care of fluorescent samples while stillkeeping signal-to-noise ratio very high and hence allows successfulmeasuring of a much wider range of raw materials compared to anyother existing handheld Raman devices,” explains Gembus.

Bruker is well known to be a very innovative company and thus alsothe BRAVO is fully packed with outstanding unique features which makeit a superior design. The combination of two lasers called Duo LASERTM

excitation allows accessing a large spectral range including informationon the CH-stretching region. “Spectral quality is most crucial for anunambiguous verification,” Gembus confirms and adds that “BRAVOfeatures IntelliTipTM, an automatic measuring tip recognition whichextends the capabilities into this direction and also prevents the Ramanlaser being fired without having a measuring tip attached. Even better,BRAVO is a class 1M laser product in all modes of operation enabling fora safe operation without the need of laser safety protection devices oraccess restrictions for third.”

Automatically included in the library, IntelliTipTM informs userswhich measuring tip needs to be used in order to get best spectralquality. Usage of the proper sample tip is always ensured. “Beingfocused on customer experiences and needs, the innovation of BRAVOcomprises an intuitive and guided workflow on a large touch screen

which is especially dedicated for the pharmaceutical manufactures. At any time all required information is clearly displayed and possibleactions can easily executed like on a cell phone. This enables everybodyto get used to BRAVO within a very short time and will speed up allworkflows at a maximum,” Gembus highlights.

Data and report transfer between the BRAVO and a PC or network is enabled either wirelessly or via a docking station depending on user-specific demands. Handling of data is done from Bruker’s OPUSspectroscopy software. “OPUS is the leading software for measurement,processing and evaluation of IR, NIR and Raman spectra,” Gembus says and continues: “BRAVO and its software suite complies with CRF 21 part 11 of the Code of Federal Regulations and meets cGMPprocedures as well.”

Discussing the further potential of BRAVO, Gembus states: “The outstanding performance of BRAVO is competitive to high perform -ance benchtop Raman spectrometers which might make BRAVO aninteresting solution for many more applications and markets in future.”

“We are never satisfied with the common market standards andcommit ourselves to always offering our customers the highest qualitysolutions including extraordinary support that ranges from training,method development to validation consultation and service. At Bruker,customers are welcome to benefit from our know-how and worldwidesupport that sets new standards on the market when it comes toprecision and efficiency, ergonomics and ease of operation, consultingand services.”

PRODUCT HUB

Armin Gembus, Global Business Unit Manager for Raman and Gas Analytics at Bruker looks at the new generation ofhandheld Raman spectrometer, the Bruker BRAVO. For more than 50 years, Bruker has enabled scientists to makebreak through discoveries and develop new applications that improve the quality of human life. Bruker’s high-performance scientific research instruments and high-value analytical solutions enable scientists to explore life andmaterials at molecular, cellular and microscopic levels. In close cooperation with their customers, Bruker is enablinginnovation, productivity and customer success in life science molecular research, in applied and pharmaapplications, in microscopy, nano-analysis and industrial applications, as well as in cell biology, preclinical imaging,clinical research, microbiology and molecular diagnostics.


Bruker Optik GmbH

Rudolf-Plank-Str. 2776275 Ettlingen

Tel. +49 7243 504 2000 Fax. +49 7243 504 2050E-Mail: [email protected] us for more details www.bruker.com/bravo

Dedicated Raw Material AnalyzerBRAVO - A new era of Handheld Raman Spectroscopy

SSETM – Sequentially Shifted Excitation mitigates fl uorescence

Duo LASERTM provides the highest sensitivity throughout a large spectral range including the CH-stretching region

IntelliTipTM – automated recognition of measurement tips

Class 1M Laser safe in all modes of operation

Intuitive and guided touch screen operation

BRAVO makes Raman analysis accessible to everybody. New technologies especially designed for BRAVO provide an effi cient verifi cation of the widest range of materials. BRAVO supports the complete manufacturing process from raw material verifi cation to fi nished product inspection with functionality that meets your requirements.

RAMANInnovation with Integrity

“The Bruker BRAVO (Bruker RAman Verification Optics) opens a new erain handheld Raman spectroscopy because it addresses all of the so farpresent limitations,” says Armin Gembus, Global Business Unit Managerfor Raman and Gas Analytics at Bruker. “Patented Sequentially ShiftedExcitation (SSETM) technique takes care of fluorescent samples while stillkeeping signal-to-noise ratio very high and hence allows successfulmeasuring of a much wider range of raw materials compared to anyother existing handheld Raman devices,” explains Gembus.

Bruker is well known to be a very innovative company and thus alsothe BRAVO is fully packed with outstanding unique features which makeit a superior design. The combination of two lasers called Duo LASERTM

excitation allows accessing a large spectral range including informationon the CH-stretching region. “Spectral quality is most crucial for anunambiguous verification,” Gembus confirms and adds that “BRAVOfeatures IntelliTipTM, an automatic measuring tip recognition whichextends the capabilities into this direction and also prevents the Ramanlaser being fired without having a measuring tip attached. Even better,BRAVO is a class 1M laser product in all modes of operation enabling fora safe operation without the need of laser safety protection devices oraccess restrictions for third.”

Automatically included in the library, IntelliTipTM informs userswhich measuring tip needs to be used in order to get best spectralquality. Usage of the proper sample tip is always ensured. “Beingfocused on customer experiences and needs, the innovation of BRAVOcomprises an intuitive and guided workflow on a large touch screen

which is especially dedicated for the pharmaceutical manufactures. At any time all required information is clearly displayed and possibleactions can easily executed like on a cell phone. This enables everybodyto get used to BRAVO within a very short time and will speed up allworkflows at a maximum,” Gembus highlights.

Data and report transfer between the BRAVO and a PC or network is enabled either wirelessly or via a docking station depending on user-specific demands. Handling of data is done from Bruker’s OPUSspectroscopy software. “OPUS is the leading software for measurement,processing and evaluation of IR, NIR and Raman spectra,” Gembus says and continues: “BRAVO and its software suite complies with CRF 21 part 11 of the Code of Federal Regulations and meets cGMPprocedures as well.”

Discussing the further potential of BRAVO, Gembus states: “The outstanding performance of BRAVO is competitive to high perform -ance benchtop Raman spectrometers which might make BRAVO aninteresting solution for many more applications and markets in future.”

“We are never satisfied with the common market standards andcommit ourselves to always offering our customers the highest qualitysolutions including extraordinary support that ranges from training,method development to validation consultation and service. At Bruker,customers are welcome to benefit from our know-how and worldwidesupport that sets new standards on the market when it comes toprecision and efficiency, ergonomics and ease of operation, consultingand services.”

PRODUCT HUB

Armin Gembus, Global Business Unit Manager for Raman and Gas Analytics at Bruker looks at the new generation ofhandheld Raman spectrometer, the Bruker BRAVO. For more than 50 years, Bruker has enabled scientists to makebreak through discoveries and develop new applications that improve the quality of human life. Bruker’s high-performance scientific research instruments and high-value analytical solutions enable scientists to explore life andmaterials at molecular, cellular and microscopic levels. In close cooperation with their customers, Bruker is enablinginnovation, productivity and customer success in life science molecular research, in applied and pharmaapplications, in microscopy, nano-analysis and industrial applications, as well as in cell biology, preclinical imaging,clinical research, microbiology and molecular diagnostics.


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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

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