Quality and safety of animal origin components used in the biologics manufacture is of the paramount importance in assuring quality and safety of the manufactured biological medicinal product. Past experience indicates that raw materials of animal origin could serve as source of adventitious agents potentially impacting the manufacturing process. Treatment of raw materials of animal origin for virus clearance is one of the ways to mitigate risk from adventitious agents in raw materials. Gamma irradiation has, for many years, been regarded as a ‘gold standard’ for virus inactivation in animal sera and the process of serum treatment by gamma rays has been well established and practiced by many serum manufacturers and serum end users. This talk will highlight some practical points to consider when designing virus evaluation/validation studies, effectiveness of gamma irradiation, and its impact on serum performance.

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