Project: Process Transfer for Phase III Trials

Company: Bio Pharma Manufacturer

Location: Leinster, Ireland

Objectives: - Process Design Development - Design / tender / procurement - Transfer from European R&D centre to clinical Phase III batch production

Our client, a major Pharma manufacturer in Leinster, wished to transfer a new process from its European R&D facility to its Irish site to facilitate Phase III clinical trials and full scale manufacture.

A key consideration was a significant change required to the pre-existing formulation, necessitating the completion of thawing and Lyophiliser loading within a shorter Time Out of Refrigeration (TOR) so as to minimise the generation of High Molecular Weight (HMW) components.

Prochem was appointed to prepare a Basis of Design, Detailed Design and Construction Management.

The scope included CSA, Process, Mechanical, Ventilation Automation and Electrical elements.  The process description was developed between the client and Prochem.

The final solution involved the use of single use technology, rapid thawing and temperature control within a formulation room of product taken from the warehouse, prior to filling and lyophilisation. In addition it involved the removal and reuse of existing equipment within a pre-existing hard piped GMP Grade A/B/C environment.

From the initial project meeting to the final handover, Prochem used a consistent and experienced team, ensuring efficient knowledge management throughout the project lifecycle, and improving the quality of the ultimate outcome.

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