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Overcoming Biosimilar Scaling Challenges.

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  • معلومة اضافية
    • الموضوع:
      UNITED States. Food & Drug Administration
    • نبذة مختصرة :
      The article focuses on the challenges of scaling biosimilar manufacturing while ensuring product consistency and regulatory compliance. Topics include the growing diversity of biosimilar modalities, the complexities of process development and optimization, and the technical hurdles in maintaining biosimilarity during large-scale production.