Four decades delivering contract pharma solutions for our partners

Alkermes Contract Pharma Services provides solid dosage form product development, scale-up and manufacturing services along with sterile fill-finish capabilities to the global pharmaceutical market. We have a long and successful history in the development and manufacture of pharmaceutical dosage forms for pharmaceutical markets worldwide. We have a blue chip list of partners and have assisted in the successful launch of multiple products in more than 100 countries in North America, Europe and Asia. Extensive development, scale-up and manufacturing capabilities in U.S. and Europe

We offer a complete range of pharmaceutical development and manufacturing capabilities to support your requirements including effective, robust and swift tech transfers, a full selection of proven and validated technology and process improvement solutions including those for high potency product development and manufacturing, competitive pricing, on time delivery with an exceptional compliance track record in FDA/EMA licensed sites in U.S. and EU. Since we began pioneering drug development solutions for the pharma industry, over 40 years ago, we have assisted in the development and launch of over 40 products in the U.S. and International markets. Modern Facilities to fit Partners Precise Product Requirements

Alkermes Contract Pharma Services offers a significant advantage in outsourcing – a broad range of services and expertise integrated into one company – based in the U.S. and Europe. This approach reduces the need for technical transfers from product development and clinical trial suppliers to commercial manufacturing sites, enabling efficient scale-up from development to commercial production. By providing the whole process in this integrated manner, we have been able to recommend ways to improve production methods – reducing partner risk and also improving efficiencies.

Capabilities and Facilities
– Dedicated tech transfer, development, scale-up and commercial manufacturing capabilities
– Modern facilities in Europe and U.S.
– 2.5 billion units annually in solid oral dosage form manufacturing capacity
– 10 million vials annually in aseptic sterile filling and finishing capacity
– 2 million pre-filled syringe capacity by 2013
– High potency product development, scale-up and manufacturing to < 0.1ug/M3
– 470,000 sq ft of cGMP manufacturing facilities
– Excellent quality and compliance record
– Packaging facilities in the U.S. and Ireland
– Mature infrastructure
– DEA approved controlled substance manufacturing plant in U.S.
– Development and manufacture of product for U.S., European, and Japanese markets as well as the emerging markets of India, China and Brazil

Range of Services
Commercially validated technologies, experience, expertise and enthusiasm together with clear and well defined communication procedures between our teams of experts and customers is key to achieving optimum solutions to meet your product requirements.

Development Capacity
Our highly experienced and accomplished scientists and support staff participate in an open and team-focused environment in the development, scale-up (and tech transfer) of your products. We actively encourage partner participation throughout the process to successfully achieve your project goals.

Specialized Development Services
Alkermes Contract Pharma Services is a leader in specialized development services with a broad platform of patented technologies. For more information on our unique drug delivery capabilities please click here.

Analytical Services
Alkermes Contract Pharma Services offers a complete range of analytical capabilities to support your requirements – be that technology transfer, scale-up, clinical trial supplies or full scale commercial manufacturing. At present, we have over 88,000 square feet of dedicated laboratory space. Process Development and Optimization

A process improvement culture has been embedded in our development facilities with our scientists actively recommending ways to improve development and production methods that can potentially reduce partner risk and also improve efficiencies. Registration Support

Our Regulatory Department has successfully assisted a number of companies with various applications to the regulatory authorities in the U.S., Europe and Japan. We provide assistance to our partners with the preparation of New Drug Applications and updates, Investigational New Drug Applications, Drug Master files and post-marketing supplements. We maintain site reference files and authorized access to drug master files as needed. Our quality group holds the responsibility of releasing our partners’ batch records and undertakes this according to internal standard operating procedures and cGMPs.

Technology Transfer
For seamless tech transfers we leverage product and process understanding, honed risk assessment, process modeling and optimized experimental approaches – thereby maximizing transfer effectiveness.

Technologies

Validated platform of drug delivery technologies
Alkermes Contract Pharma Services has a unique platform of validated drug delivery technologies to offer our partners – from oral controlled release, delayed release and pulsatile release drug delivery systems as well as solutions for poorly water soluble compounds.

We have a complete range of capabilities from formulation development through to commercial scale manufacture in modern facilities. Our drug delivery technologies are supported by robust patent estate of almost 1,500 patents and pending applications worldwide.

Platform Technologies
Bioavailability Enhancement Technology Platform – The insoluble solved™

It is estimated that in excess of 40% of compounds in development suffer from poor solubility, making them difficult to develop and resulting in a significant number of potentially beneficial compounds being discarded in development each year. Alkermes Contract Pharma Services bioavailability enhancement technology platform helps address this key problem for the pharmaceutical industry.

Improved bioavailability can bring one or more of the following benefits for a fast, elegant solution for poorly water soluble compounds:

– Increased rate of absorption
– Reduction in required dose
– Reduction in fed/fasted variability
– Improved dose proportionality
– Smaller dosage forms
– More convenient dosage forms
– Rapid formulation development
– Applicable to all routes of administration any dosage form.

Oral Controlled Release (OCR) Drug Delivery Platform
oral control release Alkermes Contract Pharma Services has developed a range and depth of solid oral dosage technologies unrivaled in drug product development. We have been applying our range of technology approaches to help overcome many of the technical difficulties that have been encountered by pharmaceutical companies.
The OCR technology platform can bring one or more of the following benefits for new and existing drug products:

– Highly flexible release profiles
– Reduced gastrointestinal irritancy
– Tableting technology within a capsule
– Hydrophilic matrix-controlled diffusion and erosion
– Bilayer technology.

More Oral Control Release Technology information

To find out if your drug candidate would benefit from our expertise in oral controlled release please contact us.