Modernizing pharmaceutical manufacturing: from batch to continuous production

SL Lee, TF O'Connor, X Yang, CN Cruz… - Journal of …, 2015 - Springer
Abstract The Food and Drug Administration (FDA) regulates pharmaceutical drug products
to ensure a continuous supply of high-quality drugs in the USA. Continuous processing has …

Regulatory perspectives on continuous pharmaceutical manufacturing: moving from theory to practice: September 26-27, 2016, international symposium on the …

MM Nasr, M Krumme, Y Matsuda, BL Trout… - Journal of …, 2017 - Elsevier
Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical
manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory …

[图书][B] Continuous manufacturing of pharmaceuticals

P Kleinebudde, J Khinast, J Rantanen - 2017 - books.google.com
A comprehensive look at existing technologies and processes for continuous manufacturing
of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical …

Design and commercialization of an end-to-end continuous pharmaceutical production process: a pilot plant case study

CJ Testa, C Hu, K Shvedova, W Wu… - … Process Research & …, 2020 - ACS Publications
The pharmaceutical industry faces multiple challenges (eg, inefficient manufacturing
techniques, quality control issues, and supply chain vulnerabilities) because of its current …

Regulatory and quality considerations for continuous manufacturing. May 20–21, 2014 continuous manufacturing symposium

G Allison, YT Cain, C Cooney, T Garcia… - Journal of …, 2015 - Wiley Online Library
This paper assesses the current regulatory environment, relevant regulations and
guidelines, and their impact on continuous manufacturing. It summarizes current regulatory …

Control systems engineering in continuous pharmaceutical manufacturing May 20–21, 2014 continuous manufacturing symposium

AS Myerson, M Krumme, M Nasr, H Thomas… - Journal of …, 2015 - Elsevier
This white paper provides a perspective of the challenges, research needs, and future
directions for control systems engineering in continuous pharmaceutical processing. The …

Achieving continuous manufacturing for final dosage formation: challenges and how to meet them. May 20–21, 2014 continuous manufacturing symposium

S Byrn, M Futran, H Thomas, E Jayjock… - Journal of …, 2015 - Wiley Online Library
We describe the key issues and possibilities for continuous final dosage formation,
otherwise known as downstream processing or drug product manufacturing. A distinction is …

Continuous manufacturing in pharmaceutical process development and manufacturing

CL Burcham, AJ Florence… - Annual review of …, 2018 - annualreviews.org
The pharmaceutical industry has found new applications for the use of continuous
processing for the manufacture of new therapies currently in development. The …

Achieving continuous manufacturing May 20–21 2014 continuous manufacturing symposium

C Badman, BL Trout - Journal of pharmaceutical sciences, 2015 - jpharmsci.org
The white papers presented here are a remarkable collection of work, unified by the goal of
building upon the in-roads that continuous manufacturing has made in the pharmaceutical …

Achieving continuous manufacturing: Technologies and approaches for synthesis, workup, and isolation of drug substance. May 20–21, 2014 Continuous …

IR Baxendale, RD Braatz, BK Hodnett… - Journal of …, 2015 - Wiley Online Library
This whitepaper highlights current challenges and opportunities associated with continuous
synthesis, workup, and crystallization of active pharmaceutical ingredients (drug …