Developing biologics in pre-filled syringes (PFS) offers significant benefits for patient convenience and safety, but ensuring a robust manufacturing process brings unique challenges. From maintaining product stability and achieving precise fill volumes to managing visual inspection and regulatory compliance across global markets, each step requires careful planning and execution. 

This whitepaper provides actionable strategies to overcome these challenges, ensuring safe and reliable delivery of biologic therapies including:

• Strategies for achieving stability and fill precision in PFS biologics
• Approaches for effective visual inspection and foreign particle control
• Navigating evolving global regulatory landscapes
• Building a strong QMS to ensure consistent quality

Download now to gain insights and actionable approaches that can strengthen your biologics development pipeline.

Scendea Authors:

Dr. Asha Kattige
Principal Consultant

Erik Doevendans
Team Lead (NL) & Principal Consultant

Chime Biologics Authors:

Jack Zeng
Associate Director

Bingming He
Senior Scientist

Dr. Peter Liu
Senior Director

Dr. Zack Zheng
Senior Vice President & Chief Technology Officer