media information 2015ingredients, packaging, drug discovery, process technology, high potency and...

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APPROVED NCENUMBERS RISEWhile numbers of new entities bounceback, the targets remain niche vii

BUILDING FORDISCOVERY

With its modern facility in Pune (above), SAIlooks at outsourcing services in India xiii

SOFTWARE FORSMARTER R&D

Software has evolved to speed discoveryR&D without losing flexibility xvi

SPECIAL REPORT:DRUG DISCOVERY

SAI Life Sciences | Discovery Unit - Pune, India

You may be thinking ‘discovery’Let’s talk about ‘discoveries’

March 2013

manufacturingchemist.com

The pharmaceutical manufacturing sector is remarkable notonly for its complexity but also for the speed at which itchanges – both in terms of technological innovation and thedynamic of the market.

The format of Manufacturing Chemist allows us to bring youup–to-the-minute developments as well as in-depth technicalarticles, market analysis and the views and insights of thosewho are shaping the industry on a daily basis.

The experienced editorial team brings you the news as ithappens through the constantly updated website, with amonthly digest of the top stories in print, covering researchand development, business, drugs, process technology,packaging, laboratory equipment and regulatory affairs. Eachissue contains technical articles that pick out the emergingtrends and developing technologies across all areas of thepharma supply chain.

Every issue includes an Interview feature, where top industryfigures have the chance to put industry events in context,discuss current challenges and opportunities and express theirhopes and fears concerning what the future may hold for theircompanies and the sector as a whole.

Each month there is a Focus on Pharma special marketreport. Over the course of the year this looks in detail atingredients, packaging, drug discovery, process technology,high potency and sterility, clinical trials, personalisedmedicine, drug delivery, outsourcing, biotechnology andQA/QC.

This discrete section of the publication includes an overview ofthe market and its trends, articles on technical innovations,and new product stories. With its own front cover andcontents, Focus on Pharma forms a pull-out library of valuableinformation.

However, because the industry is changing at such a rapidpace, every issue of Manufacturing Chemist also brings youfeatures on the latest technical developments as they occur toensure that your knowledge base is constantly kept up-to-dateacross all sectors of the industry.

In combination with the Focus on Pharma section, this pipelineof new product and technology articles enables us to give youthe best of both worlds: a focused view of the major marketsectors as well as details of the latest developments as theyhappen.

IN PRINT

CONTACT [email protected] T +44 (0)20 7193 1279

2015 EDITORIAL FEATURES

JANUARYBusiness news, laboratory equipment, pharma packaging, drug delivery, R&D,process technology, manufacturing equipment, vaccines, anticounterfeiting,contract services, clinical trials, legislation and regulatory affairsFocus on Pharma: INGREDIENTSRaw materials, intermediates, excipients, taste-masking, coatings, catalysts,APIs, colourings, enzymes, disintegrants, binders, fillers, compression agents,ligands, peptides, raw materials testing and analysis, mixing and blending

FEBRUARYBusiness news, laboratory equipment, pharma packaging, drug delivery, R&D,process technology, manufacturing equipment, vaccines, anticounterfeiting,contract services, clinical trials, legislation and regulatory affairsFocus on Pharma: PHARMACEUTICAL PACKAGINGContainers, closures, materials, labels, track and trace, anticounterfeiting,tamper-evidence, child-resistance, syringes, cartons, inspection systems,machinery and equipment

MARCHBusiness news, laboratory equipment, pharma packaging, drug delivery, R&D,process technology, manufacturing equipment, vaccines, anticounterfeiting,contract services, clinical trials, legislation and regulatory affairsFocus on Pharma: DRUG DISCOVERYNew clinical entities, proteomics, genomics, pharmacokinetics, gene expression,chiral chemistry, high throughput screening, libraries, assays, bioavailability,purification, chromatography, spectroscopy, conjugation, protein engineering,knock-out genes, gene silencing, gene shuffling, laboratory equipment

APRILBusiness news, laboratory equipment, pharma packaging, drug delivery, R&D,process technology, manufacturing equipment, vaccines, anticounterfeiting,contract services, clinical trials, legislation and regulatory affairsFocus on Pharma: PROCESS TECHNOLOGY AND EQUIPMENTAutomation and control systems, mixing and blending, pumps and valves,drying, granulation, lyophilisation, extrusion, milling, sieving, materials handlingand transfer, reactors, tanks and vessels

MAYBusiness news, laboratory equipment, pharma packaging, drug delivery, R&D,process technology, manufacturing equipment, vaccines, anticounterfeiting,contract services, clinical trials, legislation and regulatory affairsFocus on Pharma: PRECISION MEDICINEGenomics, regenerative medicine, stem cells, biomarkers, diagnostics,radiolabelling, SNPs, genetic engineering, molecular chemistry, cell therapy,epigenetics

JUNEBusiness news, laboratory equipment, pharma packaging, drug delivery, R&D,process technology, manufacturing equipment, vaccines, anticounterfeiting,contract services, clinical trials, legislation and regulatory affairsFocus on Pharma: BIOTECHNOLOGYFermentation, culture media, microbiology, mAbs, cell culture, biocatalysis,biosensors, purification, bioreactors, peptides, vaccines

JULY/AUGUSTBusiness news, laboratory equipment, pharma packaging, drug delivery, R&D,process technology, manufacturing equipment, vaccines, anticounterfeiting,contract services, clinical trials, legislation and regulatory affairsFocus on Pharma: QUALITY ASSURANCEValidation, calibration, measurement, testing and analysis equipment, weighingequipment, sampling, vision systems, metal detection, microbiological testing,leak testing, tablet counting, anticounterfeiting, batch identification, particlesizing, stability studies

SEPTEMBERBusiness news, laboratory equipment, pharma packaging, drug delivery, R&D,process technology, manufacturing equipment, vaccines, anticounterfeiting,contract services, clinical trials, legislation and regulatory affairsFocus on Pharma: DRUG DELIVERYInhalers, syringes, tablets, ODTs, capsules, injectables, parenterals, solublefilms, extended release formulations, chewing gum, transdermal patches,medical devices, nanotechnology, vaccines, containers and closures

OCTOBERBusiness news, laboratory equipment, pharma packaging, drug delivery, R&D,process technology, manufacturing equipment, vaccines, anticounterfeiting,contract services, clinical trials, legislation and regulatory affairsFocus on Pharma: OUTSOURCINGContract research, contract manufacturing, contract process development,analytical services, consultancy, facility design and build, custom synthesis,contract packing, contract clinical trial services, logistics, waste management

NOVEMBERBusiness news, laboratory equipment, pharma packaging, drug delivery, R&D,process technology, manufacturing equipment, vaccines, anticounterfeiting,contract services, clinical trials, legislation and regulatory affairsFocus on Pharma: LOGISTICSCold chain management, shipping services, containers, storage, legislation,GDP, air freight, sea freight, road transport, labelling, hazardous goods, UNcertified packaging, time/temperature monitors

DECEMBERBusiness news, laboratory equipment, pharma packaging, drug delivery, R&D,process technology, manufacturing equipment, vaccines, anticounterfeiting,contract services, clinical trials, legislation and regulatory affairsFocus on Pharma: LEGISLATION AND REGULATORY AFFAIRS Clinical trials Directive, Falsified Medicines Directive, animal testing, validation,international standards, best practice, intellectual property, auditing schemes

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EXTRA DISTRIBUTION

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In addition Manufacturing Chemist and Focus on Pharma will be distributed at Informex USA; Pharmapack; Interphex;TechnoPharm; 3C/Medtech; Pharmtech; Chemspec; CPhI

JANUARYShows: Informex, New Orleans, USA 2-5 February

FEBRUARYShows: Pharmapack, Paris, France 10-12 February

APRILShows: Interphex, New York, USA 21-23 April

JUNEShows: ACHEMA, Frankfurt, Germany 15-19 June, Chemspec Europe, Cologne, Gemany 24-25 June

SEPTEMBERShows: TechnoPharm, Nuremburg, Germany TBCPPMA, Birmingham, UK TBC

OCTOBERShows: CPhI Worldwide TBCLab Innovations, UK TBC

NOVEMBERShows: PharmTech Moscow, Russia TBC


CIRCULATION AND READERSHIPManufacturing Chemist is circulated to 7,816 managers, scientists, engineers working for the world’s leading companies involvedin manufacturing and marketing the world’s top selling biopharma and pharmaceutical prescription, generic and over-the-countermedicines.

Abbott Laboratories, Alexion, Allergen, Astellas, AstraZeneca, Amgen, Bayer Schering, Baxter BioScience, Biogen Idec, Boehringer-Ingelheim, Bristol Myers Squibb, CSL Ltd, Daiichi-Sankyo, Dendreon, EISAI, Eli Lilly & Co, Gilead Sciences, GlaxoSmithKline,Johnson & Johnson, Merck & Co, Merck Serono, Mylan, Novartis, Novo Nordisk, Otsuka Pharmaceutical, Pfizer, Roche, Sanofi,Takeda Pharma, Teva, Vertex

Geographical profileEurope - 4376

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R & D, Formulation 28%

Production, Manufacturing 24%

Packaging 17%

Quality Control, Assurance, Validation 12%

Purchasing 8%

Regulatory Affairs 6%

Management 4%

Sales & Marketing 1%

Europe 56%

Americas 26%

Asia 16%

ROW 2%

UK 48%

Germany 21%

France 14%

Switzerland 8%

Rest of Europe 9%

Primary Job function profile


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Hygienic processing places high demands on

the reliability and cleanability of production

facilities. Common challenges such as

corrosion in pipe systems, valve manifolds

and tank installations in different

pharmaceutical, chemical and biotech

facilities for example can be reduced, thereby

reducing costs and improving plant

availability - by using multiport valves and

multiport-based manifolds. Multi-port

solutions such as the Robolux valve were

developed with exactly this type of high-purity

installation in mind.

REDUCED INSTALLATION SPACE

The stand-out feature of the patented

Robolux valve design is that two independent

process switching functions can be achieved

with one membrane. This reduces the

installation space requirement, eliminates T-

adapters and minimises the overall number of

valves and membranes required. The multi-

port membrane valves were designed for

high-purity installations and make it possible

to design complex systems that are

considerably more compact than those using

conventional fluid control valves.

The design is also intended to minimise the

internal volume and produce no dead flow

zones, which results in a number of

advantages: In addition to improved flow and

evacuation properties, both cleaning and

changeover of the interfaces for the

manufacture of other products is easier and

faster, with less wastage of expensive

chemicals and ingredients.

This technology makes it possible to replace

two traditional shut-off diaphragm valves and

at the same time eliminate all dead legs and

one tee-piece with one single valve. When

combined with reduced installation and

commissioning costs, the Robolux valve

delivers a number of crucial advantages to

process control within hygienic applications.

UNIQUE TESTING ABILITY

Bürkert is able to test cleaning cycles and

provide 100% reliability on the flow properties

and cleanability of the complete valve by

using a riboflavin test rig. As part of a factory

acceptance test, Bürkert is currently the only

manufacturer of fittings and valve interfaces

in the world that owns and operates such a

test rig. In hygienic applications where CIP /

SIP are operated, it is essential to be able to

ensure the cleaning cycle is both effective

and efficient; a criterion which can be

completely fulfilled and demonstrated by

Bürkert.

INTELLIGENT FIELD DEVICE

As part of the concept to decentralise valve

control systems, the Robolux valve can now

be combined with Bürkert's ELEMENT control

head to provide a complete process solution

which is compatible with the entire valve

product range. The valves at field level can be

equipped with all the required automation

components including pilot valves, electrical

feedback units and optical status indicators.

By integrating an AS interface as a field bus

interface, the entire range of advantages of

this approach can be fully utilised. All that is

required for power supply, feedback and

communication is a two-wire line connecting

the PLC with up to 62 valves.

DECENTRALISED CONTROL

The new decentralized automation concept

can provide a viable and extremely compact

alternative to the use of central switching

cabinets by integrating all the required

automation functions in the control heads

themselves. This provides considerable

savings in installation costs and also provides

commissioning and maintenance engineers

with an instant indication of the status of

each valve, which reduces the amount of time

required for installation and trouble-shooting.

OPERATIONAL FEEDBACK

Using the control head as a central unit for

the control of the hygienic process valves,

enables it to perform all pneumatic actuation,

feedback and diagnostic functions, as well as

bus communication. A three-colour optical

status display with high-power LEDs, which is

integrated in the control head, provides for a

visual overview of the valve status at the field

level. In addition to electrical feedback to the

master controller, it also signals the current

switching position of the process valve,

facilitating diagnosis and maintenance within

the system itself.

Due to the compatibility of the IP67

ELEMENT control head with a wide range of

process control valves from Bürkert and many

other manufacturers, greater plant

standardisation can be achieved by equipping

process system with components from the

ELEMENT platform.

NEW INTELLIGENTVALVE FROM BÜRKERTREDUCES PIPEWORKBY SWITCHINGMULTIPLE FLOWSThe ideal valve for use in a hygienic processing environment is easy to clean

using CIP, contains a low internal volume and a minimum number of connections

as well as offer super precise flow control abilities.

These exact criteria were used to design the revolutionary Robolux valve from

Bürkert, which, now compatible with its ELEMENT control heads offers a cost

saving, space saving, intelligent field device which is ideally suited for use in

pharmaceutical, chemical, food and beverage processing applications.

CONTACT

BÜRKERT

Fluid Control Centre, 1 Bridge End,

Cirencester, Gloucestershire, GL7 1QY,

United Kingdom

T: +44 (0)1285 648720

E: [email protected]

F: +44 (0)1285 648721

W: www.burkert.co.uk

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Google analytics report that 656,817 unique people visited Manufacturing Chemist online since 2005. Visitorsinclude professionals working for the leading companies involved manufacturing and marketing the world’s top-selling biopharma and pharmaceutical products.

Abbott Laboratories, Alexion, Allergen, Astellas,AstraZeneca, Amgen, Bayer Schering, BaxterBioScience, Biogen Idec, Boehringer-Ingelheim,Bristol Myers Squibb, CSL Ltd, Daiichi-Sankyo,Dendreon, EISAI, Eli Lilly & Co, Gilead Sciences,GlaxoSmithKline, Johnson & Johnson, Merck & Co, Merck Serono, Mylan, Novartis,Novo Nordisk, Otsuka Pharmaceutical, Pfizer,Roche, Sanofi, Takeda Pharma, Teva, Vertex.

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media information 2015ingredients, packaging, drug discovery, process technology, high potency and...

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