Early implementation of QbD in biopharmaceutical development: a practical example.

摘要: In drug development, the "onus" of low R&D efficiency has been put traditionally onto discovery process (i.e., finding right target or "binding" functionality). Here, we show that manufacturing is not only a central component product success, but also that, by integrating and activities in "holistic" interpretation QbD methodologies, could expect to increase as whole. this new context, early risk assessment, using developability methodologies computational methods particular, can assist reducing risks during development cost-effective way. We define specific areas how they impact quality broad sense, including essential aspects such efficacy patient safety. Emerging industry practices around are introduced, some examples applications biotherapeutics. Furthermore, suggest potential workflows illustrate strategies be introduced practical terms order mitigate risks, reduce attrition ultimately robustness biopharmaceutical supply chain. Finally, discuss implementation accelerate access therapeutic treatments patients clinic.