alkermes contract pharma sevices overview presentation

Contract Pharma Services

Your Outsourcing Partner of Choice

© 2012 Alkermes. All rights reserved.

Alkermes Contract Pharma Services provides solid oral dosage product development, scale-up and manufacturing services as well as sterile fill finish capabilities to the global pharmaceutical market.

With over 40 years in the service business, we have proven expertise in drug product development, process design/improvements, tech transfer and commercial scale cGMP manufacturing of solid oral and injectable dosage forms.

Who we areHome

Who we are

Our Promise to our Partners

Strong Partnering Capabilities

Product Challenges Solved

Locations

Range of Services

Technology Platforms for Advanced Dosage Forms

Development, Scale-up & Manufacturing Capabilities

Warehouse & Packaging Capabilities

Our Legacy of Quality

Operational Excellence

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Speed to market •

Compliant, reliable and cost •efficient supplier

Effective, robust and efficient •technical transfers

Product and process optimization•

Life cycle management strategies•

Dedicated customer service•

Exceptional compliance track •record

Our Promise to our Partners A Collaborative Approach

Over 40 years experience and expertise manufacturing and developing products for our partners

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Our Partners Represent Many of the World’s Leading Pharmaceutical Companies, Including:

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Since 2001 we have successfully developed and/or tech-transferred and manufactured 12 leading pharmaceutical products for the U.S. and International markets including:

We are currently tech-transferring three additional products with global market launches by 2013.

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Locations in the U.S. and Europe

Wilmington, Ohio, U.S. – sterile fill finish facility

Gainesville, Georgia, U.S. – controlled substance, solid oral dosage facility

Athlone, Ireland – solid oral dosage facility

Over 870 employees across all sites

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Range of Services

ProcessDesign andDevelopment

ProcessScale-up

Product Launch

Commercial Supply

DEVELOPMENT SERVICES

QUALITY ASSURANCE

MANUFACTURING SERVICES

ProcessOptimization

PartnerPhase 1

PartnerPhase 2

PartnerPhase 3

PartnerPhase 4(Commercial Launchand Life Cycle Mgt.)

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NanoCrystal® Technology – A proprietary formulation and manufacturing approach for the delivery of poorly water-soluble drugs, with five commercial products launched.

Oral Controlled Release (OCR) Platform – A wide range of release profiles with 23 products commercially launched.

SODAS® Technology

IPDAS® Technology

CODAS® Technology

PRODAS™ Technology

MXDAS® Technology

DUREDAS™ Technology

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Modern Solid Oral Dose and Sterile Facilities including:

• Milling

• Screening

• Blending

• Wetgranulation(highshear and fluid bed) for solvent and aqueous processing

• Beadcoating(organicsolvent and aqueous based) using WursterFBP,CFgranulation and pans

• Tabletting

• Filmcoatingandsugarcoating

• Encapsulation(powder,bead, dual fill)

• Finishedproductpackaging(bottle/blister/vial)including cold chain capability

• Controlledsubstancemanufacture

• Asepticfillingindrypowder and liquid fill single dose vials and prefilled syringes

• Releasetesting–EUQPServiceavailableforU.S.clientsdoingbusiness in Europe

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Warehouse Capabilities

Fully automated •Movement Control System(MCS)

MCS fully integrated •with SAP inventory management

Cold storage facility•

Packaging Capabilities

Experienced staff •skilled in areas of package engineering and testing

Expertise in the •handling of schedule II compounds

Service Offerings

Bottlefillingand•packaging

Blisterpackaging–•PVC, Foil

Modern defect •detection and rejection systems

Area available for •hand packaging to accommodate ‘special’ presentations

Artwork •management

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Customer based, 20

Agency based, 7

2008

Customer based, 17

Agency based, 4

2009

Customer based, 13

Agency based, 6

2010

Customer based, 18

Agency based, 2

2011

Recent successful regulatory audits from, US FDA, UK MHRA, Brazil’s ANVISA, Saudia Arabian authorities, South Korean KFDA and the Danish Medicines Agency.

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Driving Excellence in Everything We DoLean 6 Sigma / Operational Excellence Initiatives

Right First Time

1st

OTIF Cycle Times Process Optimization

A suite of performance metrics are measured and available to our partners

Operational Excellence (OE) Initiatives

TrainedProblemSolvers(BlackBelts,GreenBelts&YellowBelts) •who anticipate, overcome and improve workflow challenges

Value Stream Structure•

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Why Work With Us?

• ExperienceandExpertise

– Over 40 years providing services to our partners with proven track record

• Theindustrytrustsus

– 30+ leading pharma companies as partners

• WideRangeofServicessetsusapart

– Effective, robust and efficient technical transfers

– Rangeofprovenandvalidatedtechnology and process improvement solutions

– ModernFacilitieswithBestinClass Systems

– Competitive pricing

– On-time delivery record

– Exceptional compliance track record

– Excellent environmental, health and safety record

• Provendrugoptimizationcapabilities with 12 products developed and/or manufactured and launched since 2001

• FDA/EMA-licensedsitesintheU.S. and Europe

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Please speak to one of our booth staff

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Otherwise you can contact us at:

Alkermes Contract Pharma Services Monksland Athlone Co Westmeath Ireland

email [email protected]

or visit www.alkermes.com/contract

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alkermes contract pharma sevices overview presentation

Health & Medicine