Product & Process Transfer Of Low Solubility Compound With 6 Year OTIF>95%

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:

• Setting up of on-site commercial systems for the NCD process as, prior to this project, only clinical batches had been manufactured
• Training of manufacturing staff as, although the site had previously used milling equipment required to manufacture the product, site knowledge was limited on this commercial system
• Introduction of new commercial technology across site functions
• Establishing new test methods at site and training of associated laboratory staff
• Transferring the process to predominantly like-for-like manufacturing equipment in order to minimize regulatory impact
• Set-up of required low bio-burden processing practices and systems
• Minimizing number of transfer runs using API due to material cost constraints.