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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The rise of gene therapies is driving rapid innovation, but manufacturers face complex challenges bringing new therapies to life
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
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