Alkermes Contract Pharma Services

As part of Alkermes plc, 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 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. We have a blue chip client list including 7 of the world’s top 10 pharmaceutical companies.

All the services we offer to our partners are provided with the greatest attention to quality and customer service. Our manufacturing business is driven by ‘excellence in everything we do’, which through our 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 proven track record

The industry trusts us:
– 30+ leading pharma companies are partners of ours

Wide range of services sets us apart:
– Effective, robust and swift technical transfers
– Range of proven and validated process improvement solutions
– High potency product development, scale-up and manufacturing
– Modern facilities with best in class systems
– Competitive pricing
– On-time delivery record
– Exceptional compliance track record
– Excellent environmental, health and safety record

FDA/EMA-licensed sites in both Europe and U.S. (and other territories including supply of product to Brazil, China and India)

As each partner is unique, we approach each project to fulfil their specific requirements and tailor our services accordingly.

Speed to market:
– Proven efficiency with on-site technical, development and manufacturing services and registration support to provide a fast efficient service Capacity to design, build, commission, qualify and commercialize solid oral dosage and powder/liquid fill-finish processes on-site Compliant, reliable and cost efficient supplier: Excellent compliance record in U.S. and Europe with experienced and motivated staff Flexible infrastructure and efficient operations with mature Lean 6 Sigma/Operational Excellence programs

Effectiveness of transfer:
We leverage through process and product understanding, honed risk assessment, process modeling and optimized experimental approaches to maximize transfer effectiveness We work to ensure transferred processes are robust and thorough through process documentation, QA systems, calibration and maintenance activities that are targeted towards key process variables/steps (i.e. waste elimination and error proofing by design)

Dedicated customer service:
– We believe in the importance of open communication – A dedicated project management resource will keep you informed at all stages in the project/commercial supply arrangement

Access to full capabilities of our sites:
– Capacity of 2.5 billion solid dosage, 10 million vial and 2 million syringe units, process and analytical equipment, high potency product development, scale-up and manufacturing, DEA-controlled site, packaging facilities for U.S. and E.U.

Access to strategic solutions for your product:
– Proven Life Cycle Management strategies
– Full CMC package capabilities for regulatory registration

Opportunity to examine tax options:
– Athlone, Ireland facility is located in a Low Tax Jurisdiction (LTJ)

Process optimization post-launch:
– Small scale, reduced API cost, material changes, additional strengths.

For a list of our Partners, please click here