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 …

A review on the modernization of pharmaceutical development and manufacturing–Trends, perspectives, and the role of mathematical modeling

F Destro, M Barolo - International journal of pharmaceutics, 2022 - Elsevier
Recently, the pharmaceutical industry has been facing several challenges associated to the
use of outdated development and manufacturing technologies. The return on investment on …

[HTML][HTML] The future of pharmaceutical manufacturing sciences

J Rantanen, J Khinast - Journal of pharmaceutical sciences, 2015 - Elsevier
The entire pharmaceutical sector is in an urgent need of both innovative technological
solutions and fundamental scientific work, enabling the production of highly engineered …

Continuous crystallization processes in pharmaceutical manufacturing: A review

J Orehek, D Teslic, B Likozar - Organic Process Research & …, 2020 - ACS Publications
This scientific paper presents an overview of continuous solution crystallization in the
pharmaceutical industry. Since the specific knowledge spectrum of precipitation is very …

A perspective on Quality-by-Control (QbC) in pharmaceutical continuous manufacturing

Q Su, S Ganesh, M Moreno, Y Bommireddy… - Computers & Chemical …, 2019 - Elsevier
Abstract The Quality-by-Design (QbD) guidance issued by the US Food and Drug
Administration (FDA) has catalyzed the modernization of pharmaceutical manufacturing …

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 …

[HTML][HTML] Applications of machine learning in antibody discovery, process development, manufacturing and formulation: current trends, challenges, and opportunities

TT Khuat, R Bassett, E Otte, A Grevis-James… - Computers & Chemical …, 2024 - Elsevier
While machine learning (ML) has made significant contributions to the biopharmaceutical
field, its applications are still in the early stages in terms of providing direct support for quality …

Progress to date in the design and operation of continuous crystallization processes for pharmaceutical applications

B Wood, KP Girard, CS Polster… - … Process Research & …, 2019 - ACS Publications
Continuous crystallization has gained interest in the pharmaceutical sector as part of the
drive toward the transition from exclusive batch manufacturing to integrated continuous …

Bioreactor control systems in the biopharmaceutical industry: a critical perspective

S Mitra, GS Murthy - Systems microbiology and biomanufacturing, 2022 - Springer
Industrial-scale bioprocessing underpins much of the production of pharmaceuticals,
nutraceuticals, food, and beverage processing industries of the modern world. The …

Challenges and opportunities in biopharmaceutical manufacturing control

MS Hong, KA Severson, M Jiang, AE Lu… - Computers & Chemical …, 2018 - Elsevier
This article provides a perspective on control and operations for biopharmaceutical
manufacturing. Challenges and opportunities are described for (1) microscale technologies …