Advanced raw material control appropriately identifies risk, deploys limited resources to manage this risk, and increases upstream supply chain flexibility and manufacturing robustness. This presentation focuses on two aspects of raw materials: rapid raw material release by technologies such Raman spectroscopy, and profiling and mapping attributes such as trace element impurities. Streamlining raw material release and implementation of Rapid ID frees up limited Quality Control resources and increases upstream supply chain flexibility by reducing time to release from weeks to minutes. Raw material characterization beyond compendial methods is an important part of managing raw material variability. Raw material characterization provides feedback to process design, building processes more robust to common raw material failure modes, as well as focusing resources on the appropriate raw material challenges. In a new manufacturing model, advanced assays may be transferred to suppliers, and electronic certificate of analysis data received into biomanufacturer systems before materials even arrive on site. Final release testing by Rapid ID and raw material attribute monitoring provide for more flexible and robust operations.

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
Analytical chemists
QA/QC analysts
R&D scientists, managers
Team members in CMC development projects
Manufacturing scientists, managers
Regulatory affairs specialists
Contract research organizations
Contract manufacturing organizations