Company Profile | September 27, 2011

Alkermes Contract Pharma Services, product development scale-up & manufacturing

Source: Alkermes Pharma Ireland Limited

Who we are - your outsourcing partner of choice

As part of Alkermes plc, Alkermes Contract Pharma Services provides solid oral dosage product development, scale-up and manufacturing services and sterile fill/finish capabilities to the global pharmaceutical market.
With over 40 years in the service business, we have proven expertise in solid oral drug product development, process design/process improvement, tech transfer and commercial scale cGMP manufacturing as well as sterile fill finishing of injectable dosage forms.

What we do

We have a long and successful history in the development and manufacture of pharmaceutical dosage forms for pharmaceutical markets worldwide.

Product Development and Optimization
We have a wide range of development and optimization services to offer our Partners. Our streamlined pathway to pharmaceutical dosage form development includes a Quality by Design (QbD) approach which allows our teams to make intelligent decisions from analytical method development right through to manufacturing process characterization.

Product Scale-up and Manufacturing
Our manufacturing group provides world-class current Good Manufacturing Practices (cGMP) scale-up and manufacturing services for solid oral dosage forms. Highly trained and experienced staff operate on a flexible manufacturing schedule - up to 24 hours a day, 7 days a week in order to meet the demands of your product. Alkermes Contract Pharma Services is driven by ‘excellence in everything we do’, which, through our integrated Operational Excellence program, gives you the reassurance that your product will be guided through our facilities to exacting specifications.

Key Benefits

 

Experience and Expertise:

  • 40+ year history in business with strong track record

Industry Trust:

  • 30+ leading Pharmaceutical Companies are partners of ours

FDA/EMA-Licensed Sites in both Europe and US:

  • Supply of product to over 100 major markets including U.S., Europe, Asia territories as well as Brazil, China and India.

Speed to Market:

  • Capacity to design, build, commission, qualify and commercialize any solid oral process on-site including highly potent compounds

Compliant, Reliable and Cost Efficient Supplier:

  • Flexible infrastructure and efficient operations with mature Lean 6 Sigma/Operational Excellence programs

Dedicated Customer Service:

  • A dedicated project management resource will keep you informed at all stages in the project/commercial supply arrangement

Access to Strategic Solutions to Extend Life of Your Product:

  • Technology expertise including: Proprietary Bioavailability Enhancement and Oral Controlled Release technology platforms
  • Proven Life Cycle Management strategies
  • Full CMC package capabilities for regulatory registration

Process Optimization Post-Launch:

  • Small scale, material changes, additional strengths.

Proven Drug Technology Expertise:

  • Proven drug optimization capabilities with 12 products developed and launched since 2001 

Capabilities

Manufacturing and Development Capabilities
At Alkermes Contract Pharma Services we have modern Solid Oral Dose Facilities to fit clients' precise product requirements, including:

  • Milling
  • Screening
  • Blending
  • Wet granulation (high shear and fluid bed) for solvent and aqueous processing
  • Bead coating (organic solvent and aqueous based) using Wurster FBP, CF granulation and pans
  • Tableting
  • Film coating and sugar coating
  • Encapsulation (powder, bead, dual fill)
  • Controlled Substance manufacture
  • Release testing - E.U. QP Service available for U.S. clients doing business in Europe
  • Drug optimization
  • Aseptic filling/finishing in dry powder and liquid fill single dose vials and prefilled syringes
  • High potency Manufacture of solid oral dosage forms

Packaging Capabilities
Experienced staff skilled in areas of packaging, engineering and testing. We fulfill specific packaging requirements such as:

  • Bottle filling and packaging
  • Blister packaging – PVC, Foil
  • Modern defect detection and rejection system
  • Hand packaging to accommodate "special" presentations
  • Artwork management

Contact Details:

Alkermes Pharma Ireland Limited
Monksland
Athlone
Co. Westmeath
IRELAND
Contact Person:  Fidelma Callanan
Tel: +353 90 649 5126
contract@alkermes.com
URL: www.alkermes.com/contract