Alkermes, through the merger with Elan Drug Technologies, to form Alkermes plc, has been developing and manufacturing commercial scale solid oral dosage products for over 40 years. This case study demonstrates the successful transfer of a low solubility compound into one of our manufacturing sites and achieving as a result, an OTIF (On-Time-In-Full) consistently over 95%.
Donor site closure required transfer to be completed in a short time frame. During this entire process, the product had to remain commercially available for the partner.
Why was Alkermes Contract Pharma Services Chosen?
The manufacturing capabilities at Alkermes were chosen as they met the donor site’s requirements of experience and expertise in working with low solubility compounds developed using the company’s proprietary NanoCrystal Colloidal Dispersion® (NCD) technology. The manufacturing capacity afforded by the Athlone Ireland facility, together with its excellent compliance record supplying product from an FDA/EMA inspected site, fulfilled all the criteria required to successfully tech-transfer this product into the facility. 26 products have been manufactured at the Athlone site since the 1970s, the majority of which are solid oral dosage forms.
Specific challenges to the project, which was the first commercial launch using the NCD technology from Athlone, included:
Alkermes’ Athlone Site
Located on a 40-acre site, with over 220,000 ft2 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 two billion solid oral doses. The Athlone site is an FDA/EMA inspected facility.
A number of significant achievements resulted from our involvement with this project. A robust technology and process transfer was achieved in 18 months. Training of staff was successfully managed which was a key component to achieve the successful manufacture of this product at commercial scale. The commercial partner was kept involved at all stages of the project which was critical in ensuring un-interrupted customer supply during the transfer process and minimization of regulatory changes.
Key activities in successful execution of this project included:
As a result of the successful tech transfer, the partner’s product was manufactured at full capacity for more than six years, consistently delivering OTIF in excess of 95%. This transfer brought the site to a more competent place allowing the site to confidently take on further commercial NCD tech transfer projects.