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Implementing quality by design for biotech products: Are regulators on track?

Francesca Luciani1, Sara Galluzzo, Andrea Gaggioli

  • 1a National Center for Immunobiologicals Control and Evaluation (CRIVIB); Istituto Superiore di Sanità ; Rome , Italy.

Mabs
|April 9, 2015
PubMed

Keywords:
BWP, Biologics Working PartyCHMP, Committee for Medicinal Products for Human UseCPPs, critical process parametersCQAs, critical quality attributesEMA, European Medicines AgencyQTPP, Quality Target Product ProfileQbD, quality by designquality by design, biotech product

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