Joint risk assessment during technical transfer - case study
A framework for donor and recipient companies to jointly analyse and document the technical and business risks associated with a technical transfer
Every technical (tech) transfer is different, with companies taking different paths toward reaching their goal. Each one presents a unique set of challenges. These challenges are most often technical, but at times they may also be business related. However, all donors (the outsourcing partner) and recipients (the contract manufacturer) have the same overall goal – to achieve a quick, efficient transfer of process and knowledge that meets all necessary quality and regulatory requirements.
To help drive the tech transfer of partner products, Alkermes sought to develop a risk assessment framework that involved both the donor company and the Alkermes transfer team in jointly assessing the tech transfer risks. This framework would address not just the usual technical challenges but also, where appropriate, the business challenges. This case study provides an overview of the implementation of this framework in a recent real-world tech transfer.
A large pharmaceutical company wished to outsource to Alkermes the commercial manufacture of a solid oral dose product, which had been in commercial production for more than five years. Alkermes had previous experience in the core technologies and processes involved. This was the donor’s first major tech transfer to Alkermes.
The challenge
The donor’s desire was to minimise regulatory changes, which meant the donor equipment train would need to be replicated wherever possible. This required the purchase, installation and qualification of new equipment at the Alkermes Athlone, Ireland site. Some of this equipment was at a working scale new to Alkermes. Existing Alkermes equipment was to be employed for one core unit operation. This required a process scale change from the donor site. A lean approach to the tech transfer was agreed i.e., only one active engineering batch was to be manufactured prior to process validation. Minimal development data or product history was shared with the recipient site.