Trace elements have significant biological relevance and can impact key performance and quality attributes of biological processes. This presentation will include case studies of impact of trace elements to monoclonal antibody drugs manufacturing and examine the contributing root causes. The talk will also focus in depth examining the variation in metal content in culture media and source of contamination. The identification of potential root causes and impurity contribution will further transition the discussion to implementing control strategies and risk management of the raw material supply chain of chemically defined media formulations. Supply chain of raw materials for chemically defined media formulations needs to be evaluated with multiple industry vendors, and control strategies must be implemented continuously monitored due to the global and complex sourcing of raw material supply chain. This will include Janssen’s strategy for control, key regulatory and compliance considerations, and strategy to ensure business continuity and availability of life saving therapies for patients.

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