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.
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