Alkermes Contract Pharma Services - Outsourcing Partner for Pharmaceutical Product Development and Manufacturing

Alkermes Contract Pharma Services is a global business that provides product development, scale-up and manufacturing services to the pharmaceutical market. It is part of Alkermes plc. With over 40 years in the service business, we have assisted our blue chip list of partners in the successful launch of multiple products in more than 100 countries, including North America, Europe and Asia.

Development and manufacture of pharmaceutical dosage forms

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

Pharmaceutical dosage form development and optimisation

We have a wide range of development and optimisation 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 characterisation.

Solid oral dosage form 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, seven 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 programme, gives you the reassurance that your product will be guided through our facilities to exacting specifications.

Benefits of Alkermes' pharmaceutical product development and manufacturing services

• 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, including supply of product to Brazil, China and India
• Speed to market: capacity to design, build, commission, qualify and commercialise any solid oral process on-site
• Compliant, reliable and cost-efficient supplier: flexible infrastructure and efficient operations with mature Lean 6 Sigma / operational excellence programmes
• 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 bioavailability enhancement and oral controlled release platforms, proven lifecycle management strategies, intellectual property portfolio of 1,500+ patents / applications and expertise, and full CMC package capabilities for regulatory registration
• Process optimisation post-launch: small scale, reduced active pharmaceutical ingredients (API) cost, material changes, additional strengths
• Proven drug technology expertise: proven drug optimisation capabilities with 12 products developed and launched since 2001

Pharmaceutical 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 - EU QP service available for US clients doing business in Europe
• Drug optimisation

Pharmaceutical packaging capabilities

Our experienced staff are skilled in the areas of packaging, engineering and testing. We fulfil 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