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
Why Work With Us?
Contact Information
Contract Pharma Services
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© 2012 Alkermes. All rights reserved.
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
Home
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
Why Work With Us?
Contact Information
Contract Pharma Services
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© 2012 Alkermes. All rights reserved.
Strong Partnering Capabilities
Our Partners Represent Many of the World’s Leading Pharmaceutical Companies, Including:
Home
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
Why Work With Us?
Contact Information
Contract Pharma Services
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© 2012 Alkermes. All rights reserved.
Product Challenges Solved
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.
Home
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
Why Work With Us?
Contact Information
Contract Pharma Services
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© 2012 Alkermes. All rights reserved.
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
Home
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
Why Work With Us?
Contact Information
Contract Pharma Services
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© 2012 Alkermes. All rights reserved.
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.)
Home
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
Why Work With Us?
Contact Information
Contract Pharma Services
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© 2012 Alkermes. All rights reserved.
Technology Platforms for Advanced Dosage Forms
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
Home
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
Why Work With Us?
Contact Information
Contract Pharma Services
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© 2012 Alkermes. All rights reserved.
Development, Scale-up & Manufacturing Capabilities
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
Home
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
Why Work With Us?
Contact Information
Contract Pharma Services
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© 2012 Alkermes. All rights reserved.
Warehouse & Packaging Capabilities
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
Home
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
Why Work With Us?
Contact Information
Contract Pharma Services
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© 2012 Alkermes. All rights reserved.
Our Legacy of Quality
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.
Home
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
Why Work With Us?
Contact Information
Contract Pharma Services
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© 2012 Alkermes. All rights reserved.
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•
Home
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
Why Work With Us?
Contact Information
Contract Pharma Services
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© 2012 Alkermes. All rights reserved.
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
Home
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
Why Work With Us?
Contact Information
Contract Pharma Services
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© 2012 Alkermes. All rights reserved.
Please speak to one of our booth staff
Contact Information
Otherwise you can contact us at:
Alkermes Contract Pharma Services Monksland Athlone Co Westmeath Ireland
email [email protected]
or visit www.alkermes.com/contract
Home
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
Why Work With Us?
Contact Information
Contract Pharma Services
13 of 13