John Sotirakos

• The gene therapy field is poised to deliver an increasingly broad and impactful set of treatments across many different diseases.
• A linchpin for success is a robust, cost-efficient, and scalable viral vector manufacturing workflow.
• Standardized production methods and fit-for-purpose workflow technologies are now available to address the unique development and manufacturing needs of viral vectors.
• Access to the necessary capacity and expertise along with strategies for a simplified pathway to GMP manufacturing, a shorter process development timeline, and a reduction in the exorbitant fixed costs associated with facility development are also available to help realize the true potential of gene therapy manufacturing space.

• While gene therapies can offer remarkable outcomes for patients, realizing their full potential requires an efficient workflow for viral vector production.
• Faced with limited process development and manufacturing expertise, gene therapy innovators can partner with integrated solution providers to fill these gaps and ensure a robust, optimized, and scalable viral vector production process.
• An integrated solution provider offers significant advantages in contrast to an assemblage of multiple suppliers focused on individual workflow steps which may lack a holistic view of operations.

• Viral vectors are the most reliable and sought-after method for gene delivery.
• Use of adherent cell culture for manufacturing these vectors, however, can lead to limited cell growth, lower productivity, and necessitate use of animal-derived media supplements which increase the risk of introducing adventitious agents.
• The VirusExpress® 293 AAV production platform reduces risk and accelerates timelines with use of chemically defined animal component-free cell culture media that has been optimized for viral vector manufacturing.

• Cell and gene therapies have delivered remarkable outcomes for patients with a wide variety of diseases and conditions.
• These therapies rely on adeno-associated viral (AAV) vectors and lentiviral vectors and are essential for delivery of genetic material into target cells.
• Use of adherent cell cultures for vector production are limited in terms of scalability and have historically relied on media formations that were not optimized and supplemented with fetal bovine serum.
• In contrast, suspension culture systems deliver significant benefits for upstream viral vector production processes including higher AAV and lentivirus vector titers and robust scalability.