How to Mitigate Risk for Biologics During Fill/Finish Manufacturing

As more biologics move through research and development, the demand for specialized aseptic fill/finish services has steadily climbed. Aseptic processing with the highest degree of sterility assurance, filling accuracy and quality is critical for high-value, small-batch therapies. Anything less impacts regulatory compliance, project timelines and—most importantly—patient safety.

This white paper explores the specialized equipment, expertise, and services needed for efficient biologics fill/finish manufacturing. Top takeaways include:

• The benefits of single-use aseptic filling systems and gloveless robotic handling
• How automation can reduce variability and speed up manufacturing
• How to maintain yield and prevent impurities during scale-up
• Qualities to look for in a biologics service provider

By: Dan Perrin, Director of Manufacturing, Winnipeg, MB, Canada