Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations | Agenda Bookshop Skip to content
Selected Colleen Hoover Books at €9.99c | In-store & Online
Selected Colleen Hoover Books at €9.99c | In-store & Online
A01=and Medicine
A01=Board on Chemical Sciences and Technology
A01=Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing
A01=Division on Earth and Life Studies
A01=Engineering
A01=National Academies of Sciences
Age Group_Uncategorized
Age Group_Uncategorized
Author_and Medicine
Author_Board on Chemical Sciences and Technology
Author_Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing
Author_Division on Earth and Life Studies
Author_Engineering
Author_National Academies of Sciences
automatic-update
Category1=Non-Fiction
Category=M
Category=PN
COP=United States
Delivery_Delivery within 10-20 working days
Language_English
PA=Available
Price_€50 to €100
PS=Active
softlaunch

Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations

In 2002, the U.S. Food and Drug Administration (FDA) launched the Pharmaceutical Quality for the 21st Century Initiative to encourage adoption of innovative technologies that would lead to an agile, flexible pharmaceutical manufacturing sector. The goal was to encourage a transition to manufacturing processes and approaches that could produce high-quality drugs reliably without extensive regulatory oversight. Much progress has been made toward that goal as the industry has developed and advanced new technologies, but more progress is required as recent natural disasters and the coronavirus pandemic have revealed vulnerabilities in supply chains and highlighted the need to modernize pharmaceutical manufacturing further.

At the request of the FDA Center for Drug Evaluation and Research (CDER), Innovations in Pharmaceutical Manufacturing on the Horizon identifies emerging technologies - such as product technologies, manufacturing processes, control and testing strategies, and platform technologies - that have the potential to advance pharmaceutical quality and modernize pharmaceutical manufacturing for products regulated by CDER. This report describes many innovations to modernize the manufacture of drug substances and drug products, to advance new control approaches, and to develop integrated, flexible, and distributed manufacturing networks within 5-10 years.

Table of Contents
  • Front Matter
  • Summary
  • 1 Introduction
  • 2 Innovations in Manufacturing Drug Substances
  • 3 Innovations in Manufacturing Drug Products
  • 4 New Control Approaches to Enable Quality Assurance and Process Capability
  • 5 Innovations in Integrated, Flexible, and Distributed Manufacturing Networks
  • 6 Advancing Innovation: Observations, Challenges, Opportunities, and Recommendations
  • Appendix A: Biographic Information on the Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing
  • Appendix B: Disclosure of Unavoidable Conflicts of Interest
  • Appendix C: Workshop and Webinar Agendas
  • Appendix D: Innovations in Pharmaceutical Manufacturing Proceeding of a Workshopin Brief
  • Appendix E: Barriers to Innovations in Pharmaceutical Manufacturing Proceeding of a Workshopin Brief
See more
Current price €63.64
Original price €66.99
Save 5%
A01=and MedicineA01=Board on Chemical Sciences and TechnologyA01=Committee to Identify Innovative Technologies to Advance Pharmaceutical ManufacturingA01=Division on Earth and Life StudiesA01=EngineeringA01=National Academies of SciencesAge Group_UncategorizedAuthor_and MedicineAuthor_Board on Chemical Sciences and TechnologyAuthor_Committee to Identify Innovative Technologies to Advance Pharmaceutical ManufacturingAuthor_Division on Earth and Life StudiesAuthor_EngineeringAuthor_National Academies of Sciencesautomatic-updateCategory1=Non-FictionCategory=MCategory=PNCOP=United StatesDelivery_Delivery within 10-20 working daysLanguage_EnglishPA=AvailablePrice_€50 to €100PS=Activesoftlaunch
Delivery/Collection within 10-20 working days
Product Details
  • Dimensions: 216 x 279mm
  • Publication Date: 08 May 2021
  • Publisher: National Academies Press
  • Publication City/Country: United States
  • Language: English
  • ISBN13: 9780309088671

Customer Reviews

Be the first to write a review
0%
(0)
0%
(0)
0%
(0)
0%
(0)
0%
(0)
We use cookies to ensure that we give you the best experience on our website. If you continue we'll assume that you are understand this. Learn more
Accept