How Preclinical Manufacturing Can De-Risk the Path to GMP-Ready Viral Vector Programs
In this GEN webinar, Chris Nieder, an expert in viral vector programs, will examine how strategically designed preclinical manufacturing campaigns provide a practical foundation for GMP production. The post How Preclinical Manufacturing Can De-Risk the Path to GMP-Ready Viral Vector Programs appeared first on GEN - Genetic Engineering and Biotechnology News .
Title: Preclinical Manufacturing: Reducing Risk on the Route to GMP-Ready Viral Vector Programs
Sk pharmteco's Senior Director and Head of Technical Development, Chris Nieder, will discuss how to effectively de-risk the journey from preclinical to GMP manufacturing for viral vector programs. In a GEN webinar, he will delve into strategies for leveraging non-GMP AAV, lentiviral, and adenoviral production to address various stages of development, including R&D, animal studies, toxicology planning, assay development, and manufacturability assessment.
Nieder emphasizes the importance of using process and analytical data generated during the preclinical phase to reduce duplicated work, lower technical risk, and streamline later scope definition. The webinar will also cover the most suitable production methods, such as shake flasks, development-scale bioreactors, or pilot-scale production, to gain valuable insights at each development step.
Attendees will learn how to align material use, analytical testing, documentation, and expectations without overstating the GMP-readiness of preclinical material. The event will feature a live Q&A session, providing an opportunity to engage with the expert panelist.
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