Everything you need to know to move Gene Therapy from development to patients
The field of Gene Therapy is continuing to evolve at a rapid speed and understanding the basics of viral vector manufacturing is vital to staying competitive and possibly differentiating factor in the journey commercialization. Leveraging our vast experience in viral vectors, we have custom-designed this course to cater to the numerous partners involved in technical and management teams of Process Development across the gene therapy space and the many others who seek to enter this space.
In 9 virtual sessions, over 3 weeks, MilliporeSigma’s Gene Therapy University will provide you with a complete overview of end-to-end bioprocessing of viral vectors starting with basic science through upstream PD, downstream PD, analytics, tech transfer and single use facility considerations.
Enroll before Aug 15 to receive a 30% discount. Classes start September 13.
Viral Vectors as Delivery Vehicles
- This session will review and highlight the features of the “common” viral vectors that are being used today in the clinic for gene therapy applications. In addition, you will learn how these viral vectors are produced and how they are used for different clinical applications.
Upstream Operations Cell Line Development
- Mammalian and insect cell lines are the biological “factories” that are used for the production of many biologics, including present day viral vectors. This session will dive into the origins of such cell lines and how they can be manipulated and engineered for isolating cell lines that meet today’s need for high level production and efficiency.
Upstream Operations Media Development and Transfection
- A key lever in generating higher viral genome titers is by optimizing growth medium conditions for your chosen cell line(s) such as HEK293 and Baculovirus Sf9. Transfection is a critical step in upstream processing driving towards higher yields. At the end of this session, you should be able to understand trends in media development through the lens of adherent and suspension systems, best practices, real-life case studies on transfection optimization and practical strategies to implement in your upstream labs.
Upstream Operations Bioreactor Growth and Kinetics
- This session highlights basic and advanced principles on the function, automation, and operation of bioreactors along with scaling methodologies and troubleshooting. At the end of this session, you should be able to identify the types of bioreactors and which part of production they are used for, how a bioreactor functions and the principles to guide scaling upstream processes to larger or smaller scales.
Assay Development and Validation
- This session focuses on the role of assay development in bringing viral vector-based therapies to market. In this session, you’ll learn about the founding principles used to guide assay design, development and validation; and how they can be used today to incorporate tomorrow’s need.
Downstream Ops 1 Harvest, Lysis, DNA Digestion, Clarification, TFF
- Midstream/Downstream processing can pose a major bottleneck in viral vector manufacturing. It is important to have a proper understanding of the different unit operations after Harvest such as Cell Lysis-DNA Digestion-depth filtration/clarification and TFF1 to ensure high recoveries of your viral vector. In this session, you will learn about key data-driven considerations and best practices for gene therapy downstream process development. We will focus on how to select and optimize the right filtration and purification technologies.
Downstream Ops 2 Chromatography, Virus Filtration, TFF
- Downstream processing is a major bottleneck in viral vector manufacturing. It is important to have a proper understanding of the different downstream operations starting from Chromatography-virus filtration-TFF2 and Aseptic filtration to piece together a robust process. In this session, you will learn about key data-driven considerations and best practices for gene therapy downstream process development. We will focus on how to select and optimize the right filtration and purification technologies.
Technology Transfer and Commercialization
- Tech transfer in viral vector bioprocessing often is the leading cause of project derailment. A good understanding of developmental challenges and regulatory landscape will prepare you well in the journey towards commercialization. At the end of the session, the participants will learn viral vector process workflows, process characterization insights, tech transfer strategies and key lessons learned from a CDMO perspective.
Facility Set-up and Single Use Considerations
- Rush to commercialization requires implementation of successful strategies in a manufacturing environment such as single use technologies. This presentation explains the what, when, why, and how to gain the increased productivity, ease of use, and speed-to-market advantages that single-use brings to viral vector biomanufacturing and case study on how to enable the purpose-fit implementation of single-use technology into your facility.
- Webinar: Developing A Scalable Upstream Bioreactor Process for Lentiviral Vector Production in Suspension - September 1, 2021
- Gene Therapy University Discounted Enrollment - July 22, 2021
- GEN Regulatory Podcast link LIVE! - July 8, 2021