Alkermes, through the merger with Elan Drug Technologies, to become Alkermes plc, has been developing and manufacturing commercial scale solid oral dosage products for over 40 years. The case study below demonstrates a large pharmaceutical contract manufacturing engagement in which there has been five years trouble free supply with OTIF (On-Time-In-Full) consistently >95%. Process and product improvement initiatives were also delivered, which enabled significant capacity and yield improvements. These improvements resulted in significant cost savings for the partner.
In 2004, we were approached by a large international pharmaceutical company, to supply manufacturing services for a solid oral dosage product. This marked only the second time this large pharmaceutical company sought assistance (pre-launch) from a third party to manufacture a product on its behalf. The Alkermes Athlone Ireland site was chosen as the preferred site to fulfill the expected commercial demands of the product as the launch was being rolled out throughout Europe.
Why the Alkermes Contract Pharma Services, Athlone Ireland plant was chosen?
Alkermes Contract Pharma Services manufacturing plant in Ireland was chosen because the site met the partner’s dual requirements of experience and expertise in solid oral development and manufacturing. The manufacturing capacity afforded by the Athlone facility, together with its excellent compliance record supplying product from an FDA/ EMA inspected site, provided the large pharmaceutical company with the assurances it required to outsource its manufacturing requirements. The Athlone plant also had well-established credentials in delivering process improvements for partners. 26 products have been manufactured in the Athlone site since the 1970s – the majority of which are solid oral dosage forms.
The immediate challenge was to develop a high yield, robust process to manufacture a multi-coated enteric coat product where other companies had experienced significant problems in aggregation and in functional coat failure. An additional challenge was to deliver a solution quickly as the product had high volume requirements for launch.
Alkermes’ Athlone Site
Located on a 40-acre site, with over 220,000 sq ft of dedicated cGMP grade facilities, this site has a proven manufacturing track-record with many products optimized and manufactured for partners in multiple territories. The facility has an equipped annual capacity of 2 billion solid oral doses. The Athlone site is an FDA/EMA inspected facility.
A number of significant achievements resulted from our involvement in this project. A robust process development and tech transfer was achieved in significantly less time than the partner's best case time estimate for the project.
The Athlone plant manufactured at full capacity for more than 5 years consistently delivering OTIF in excess of 95% and ranking at or close to the top of the partner’s league table of suppliers. Over the 5 year period more than 1 billion doses of product were manufactured for this partner.