Go behind the curtain as we delve into sterile filling equipment readiness and its crucial role in the drug delivery innovation ecosystem. Understanding the collaboration between Contract Development and Manufacturing Organizations (CDMOs) and their equipment vendors is essential for ensuring successful and timely product delivery. Our expert panel, featuring representatives from Bausch+Stroebel, SKAN, and Grand River Aseptic Manufacturing, will discuss how sterile filling equipment adapts to variations in drug delivery systems while maintaining compliance with regulatory requirements.

 Key topics include: 

• • The journey from concept to reality: What happens when custom components are involved?
• • Overcoming challenges: Insights into using novel components and ensuring smooth operations across technologies.
• • Adhering to regulatory standards: Maintaining Annex 1 compliance amidst flexible equipment and shifting industry demands.
• • Unique capabilities of CDMOs: Why their investments in filling lines for syringes and cartridges position them as leaders in the market.

Whether you're a pharmaceutical or biotech professional looking to enhance your understanding of the filling process or seeking strategies to impact your product's success, this webinar is tailored for you. Don't miss this opportunity to go behind the scenes with industry leaders and gain valuable insights on the CDMO’s role in device delivery ecosystems.

Effective DNA clearance is essential in viral vector manufacturing to ensure product purity, regulatory compliance, and patient safety. As demand for AAV and LVV-based cell and gene therapies grows, biopharmaceuticals and CDMOs must adopt scalable, high-performing endonucleases. 

This study evaluated Roche’s EndoCleave endonuclease against commercial benchmarks using a transient transfection platform with suspension HEK293 cells. Two Proof-of-Concept studies assessed performance across key process parameters—enzyme concentration, incubation time, temperature, and salt conditions—representative of AAV and LVV production. 

EndoCleave consistently matched the performance of commercially available endonuclease in reducing host cell and plasmid DNA without impacting viral titers. Its activity remained robust under varying conditions, confirming suitability for both AAV and LVV workflows. 

These results suggest EndoCleave as a reliable, scalable solution for removing nucleic acid in GMP-ready vector manufacturing environments and could also be a potential cost-effective solution.

In this webinar, SGS’s Microbiology Manager, Patricia Peron, will take a deep dive into:

• What is Bacterial Endotoxin Testing (BET)?
• USP Chapter <86> 
• A Case Study 
• Conclusions 

Stick around after the presentation for a Q&A where you will be able to submit questions.