Continuous Manufacturing of Pharmaceuticals

Kleinebudde, Peter, Khinast, Johannes, Rantanen, Jukka

  • 出版商: Wiley
  • 出版日期: 2024-10-28
  • 售價: $7,040
  • 貴賓價: 9.5$6,688
  • 語言: 英文
  • 頁數: 640
  • 裝訂: Hardcover - also called cloth, retail trade, or trade
  • ISBN: 1119001323
  • ISBN-13: 9781119001324
  • 海外代購書籍(需單獨結帳)

相關主題

商品描述

A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals

As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency.

This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles.

  • Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing
  • Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design
  • Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions
  • Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products

Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

商品描述(中文翻譯)

《藥品持續製造的全面探討》

隨著新藥開發成本的上升,製藥行業面臨著提高製造效率的巨大壓力。持續過程製造提供了一個經過驗證的解決方案。其眾多優點包括:最小化廢物、能源消耗和原材料使用;加速新藥的推出;使用較小的生產設施,降低建築和資本成本;能夠持續監控藥品質量;以及增強的過程可靠性和靈活性。《藥品持續製造》為專業人士準備了利用這一令人興奮的新方法來提高藥品製造效率的機會。

本書涵蓋了藥品持續製造的關鍵方面。第一部分提供了關鍵化學工程原則和當前監管環境的概述。第二部分介紹了製造小分子產品和蛋白質/肽產品的現有技術。接下來的部分專注於持續運行製造環境的過程分析工具。最後兩個部分探討了將多個單獨的處理部分整合成完全運行的持續過程系統,並總結了創新新製造原則的最先進方法。

- 整合了藥品製造、化學、食品和製藥科學領域中從事持續處理的專業人士所需的基本知識
- 涵蓋化學工程原則、監管方面、主要和次要製造、過程分析技術和設計質量
- 包含來自領先製藥公司、FDA和學術機構的研究者的貢獻
- 提供對未來最具前景的創新藥品持續製造方法的深入見解

及時、全面且權威的《藥品持續製造》是從事藥品開發和製造領域的行業和學術研究者的重要專業資源。

作者簡介

Editors

Peter Kleinebudde is Professor for Pharmaceutical Technology at Heinrich-Heine-University Duesseldorf, Germany, and Vice-Dean of the Faculty of Mathematics and Natural Sciences. His main research area is development, production and characterization of solid dosage forms.

Johannes Khinast is Professor of Chemical and Pharmaceutical Engineering and Head of the Institute of Process and Particle Engineering at the Graz University of Technology, Austria.

Jukka Rantanen is Professor of Pharmaceutical Technology and Engineering at the Department of Pharmacy, University of Copenhagen, Denmark.

作者簡介(中文翻譯)

編輯

彼得·克萊內布德(Peter Kleinebudde)是德國杜塞爾多夫海因里希·海涅大學(Heinrich-Heine-University Duesseldorf)藥物技術的教授,並擔任數學與自然科學學院的副院長。他的主要研究領域是固體劑型的開發、製造和特性分析。

約翰內斯·金納斯特(Johannes Khinast)是奧地利格拉茨科技大學(Graz University of Technology)化學與藥物工程的教授,並擔任過程與顆粒工程研究所的所長。

尤卡·蘭塔寧(Jukka Rantanen)是丹麥哥本哈根大學(University of Copenhagen)藥學系的藥物技術與工程教授。