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.
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 and sterile liquid and powder fill finishing
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 for the supply of product to over 100 major markets including the US, Europe, Asia territories as well as Brazil, China and India
- Speed to market: capacity to design, build, commission, qualify and commercialise 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 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: proprietary technology expertise including bioavailability enhancement and oral controlled release platforms, proven lifecycle management strategies and full CMC package capabilities for regulatory registration
- Process optimisation post-launch: small scale, 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:
- 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
- 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
- Aseptic filling / finishing in dry powder and liquid fill single dose vials and prefilled syringes
- High potency manufacture of solid oral dosage forms
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