Risk Identification and Management

Context: A major pharmaceuticals company had moved from processing monoclonal antibody manufacture from a single established manufacturing site to a new, international site in pursuit of a multi-manufacturing site strategy. However, in the new site, final product glycosylation was inconsistent, leading to excess process wastage.

Solution: IPAV visited both manufacturing sites and reviewed all reagents, cell lines, processes and standard operating procedures (SOPs), as well as conducting a root cause analysis. The issue was discovered to be additional retentate holding time in the new facility during downstream processing (DSP). New standard operating procedures (SOPs) were developed by IPAV and staff were trained accordingly.

Outcome: Quality assurance criteria were now met and glycosylation was consistent, leading to swift reduction in process wastage. Data sufficient to satisfy regulatory officers was obtained and, therefore, supply chain disruption was minimised.