Growing viral vectors for groundbreaking new gene therapies poses complex challenges. Without the benefit of established process templates, manufacturers must work quickly within compressed timeframes and make efficient upstream decisions concerning raw materials, cell culture media preparation, and more. Decisions without proper risk mitigation may prove to have serious and irreversible consequences.
Critical areas typically include:
|
|
To minimize variability and risk within these interrelated processes, gene therapy manufacturers often rely on an experienced biopharma partner with expertise across the full array of technologies, products, process templates and services.
Video: Efficient DNA Clearance
Brochure: Benzonase® Endonuclease Safety Plus Emprove® Expert
Flyer: Optimization of Benzonase® Endonuclease Use in Virus Purification
Poster: Considerations for Development of a Platform Lentivirus Harvest Clarification Process for Cell and Gene Therapy
Webinar: Sf-RVN Cell Line and CD Media Platform: A Production Platform for VLP and AAV
Webinar: Using a 3-L Disposable Bioreactor to Increase Your Throughput Development Capacity
Webinar: Mobius® Single-use Bioreactors Scalability - Bench to Clinical Scale
Data Sheet: VirusExpress® Lentivirus Production Platform
Data Sheet: VirusExpress® AAV Production Platform
Brochure: VirusExpress® 293 Production Platform
Article: Midstream Unit Operations: Unsung Heroes in AAV Process Development
Article: Removing DNA and RNA Using Benzonase® Endonuclease During Viral Production
Efficient virus purification processes can improve yield, decrease time to patient, and lower manufacturing costs
Formulating a commercially viable gene therapy demands a high level of application and regulatory expertise
Critical biosafety testing and characterization of viral vector products can help mitigate safety concerns and increase product understanding
CDMO partnerships play a critical role in advancing clinical pipelines and achieving successful commercialization