Project Management

Late Phase Microbial Project

A late phase programme would typically be performed in ABC 5000. The scope and timeframe of these programmes is much more variable and is largely dependent on the commercialisation strategy for the product.

The programme would typically consist of:

• laboratory process characterisation (LPC) studies
• transfer to ABC 5000
• cGMP manufacture in ABC 5000 (to support ongoing late-phase trial, multiple batch validation campaign or market supply)
• regulatory submission support