Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT).
نویسندگان
چکیده
Substantial changes in Pharmaceutical R&D strategy are required to address existing issues of low productivity, imminent patent expirations and pressures on pricing. Moves towards personalized healthcare and increasing diversity in the nature of portfolios including the rise of biopharmaceuticals however have the potential to provide considerable challenges to the establishment of cost effective and robust supply chains. To guarantee product quality and surety of supply for essential medicines it is necessary that manufacturing science keeps pace with advances in pharmaceutical R&D. In this position paper, the EUFEPS QbD and PAT Sciences network make recommendations that European industry, academia and health agencies focus attention on delivering step changes in science and technology in a number of key themes. These subject areas, all underpinned by the sciences allied to QbD and PAT, include product design and development for personalized healthcare, continuous-processing in pharmaceutical product manufacture, quantitative quality risk assessment for pharmaceutical development including life cycle management and the downstream processing of biopharmaceutical products. Plans are being established to gain commitment for inclusion of these themes into future funding priorities for the Innovative Medicines Initiative (IMI).
منابع مشابه
Strategic framework for education and training in Quality by Design (QbD) and process analytical technology (PAT).
The regulatory and technical landscape of the pharmaceutical field is rapidly evolving from one focused predominantly on development of small molecules, using well established manufacturing technologies towards an environment in which biologicals and complex modalities are being developed using advanced science and technology coupled with the application of modern Quality by Design (QbD) princi...
متن کاملCombining a Compact Process Analytical Technology (PAT) Analyzer, Analytics, and Applications in a Quality by Design (QbD) Environment
Application Note Technological advances in analytical instrumentation and computing systems have allowed many industries to better monitor and control business critical processes. This has enabled proactive, not reactive approaches to real-time quality assurance and product release. Until the advent of QbD and subsequent PAT initiatives, pharmaceutical and related industries were not fully equi...
متن کاملRaman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing
Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process analytical technology (PAT), and continuous manufacturing are major factors effecting new approaches to pharmaceutical manufacturing and bioprocessing. In this review, we highlight new technology developments, data analysis models, and applications of Raman spectroscopy, which have expanded the scope of Raman spe...
متن کاملAnalytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics
Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
- European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
دوره 47 2 شماره
صفحات -
تاریخ انتشار 2012