To move viral vector programs from early research toward the clinic, sponsors have to generate the right material and data during development. Non-GMP production of adeno-associated virus (AAV), lentiviral, and adenoviral vectors can support applications ranging from R&D and animal studies to assay development, toxicology planning, and early manufacturability assessments. But to be successful, sponsors have to align production scale, analytical testing, documentation, and material use with the specific questions their studies aim to answer.
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. He will discuss topics such as how to select from among shake flasks, development-scale bioreactors, and pilot-scale approaches; and how to use early process and analytical data to identify yield and scalability challenges. Attendees will also learn how early CDMO engagement can clarify manufacturing scope, timelines, costs, and GMP-readiness without compromising expectations for non-GMP material. Key takeaways from the webinar include:
- How early-stage sponsors can use non-GMP AAV, lentiviral, and adenoviral production to support R&D, animal studies, toxicology planning, assay development, and manufacturability assessment
- How process and analytical data generated before GMP can reduce duplicated prep work, lower technical risk, and streamline later scope definition
- When shake flasks, development-scale bioreactors, or pilot-scale production can provide the most useful insight for the next development step
- How to align material use, analytical testing, documentation, and expectations without over-positioning preclinical material as clinical-grade supply
A live Q&A session will follow the presentation offering you a chance to pose questions to our expert panelist.
Produced with support from:
