Project Management

Early Phase Microbial Project

These programmes are designed with the customer to support Phase I and II trials. They typically consist of the following stages:

• technology transfer
• process creation (if expression system development is required)
• process & assay development and/or establishment (inc. cell banking)
• process demonstration
• cGMP Manufacture in ABC1000 (including preparation and batch review)

A typical programme takes approximately 9-14 months until completion and would deliver:

• cGMP material suitable for use in clinical trial
• material that could be used in preclinical studies
• a robust manufacturing process
• reports detailing development work and manufactures undertaken