Viral Vector Upstream Processing
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.
Related Resources
Article: Midstream Unit Operations: Unsung Heroes in AAV Process Development
Article: Removing DNA and RNA Using Benzonase® Endonuclease During Viral Production
Article: Considerations for Development of a Platform Lentivirus Harvest Clarification Process for Cell and Gene Therapy
Product Guide: Upstream Chemicals for Bioprocessing
Workflow
Viral Vector Downstream Processing
Efficient virus purification processes can improve yield, decrease time to patient, and lower manufacturing costs
Viral Vector Formulation and Final Fill
Formulating a commercially viable gene therapy demands a high level of application and regulatory expertise
Viral Vector Characterization and Biosafety Testing
Critical biosafety testing and characterization of viral vector products can help mitigate safety concerns and increase product understanding
Viral Vector Contract Development and Manufacturing
CDMO partnerships play a critical role in advancing clinical pipelines and achieving successful commercialization
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