Process Development

Feb 01, 2018
Pharmaceutical Technology
Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities.
Feb 01, 2018
By Pharmaceutical Technology Editors
A collaboration between The Centre for Process Innovation and The Roslin Institute aims to develop commercially viable and scalable methods of producing biologics using transgenic animals.
Jan 23, 2018
By Pharmaceutical Technology Editors
The funding from the Walloon Region will enable Univercells to start developing a manufacturing platform aimed at driving down costs of biosimilars manufacturing.
Dec 19, 2017
By Pharmaceutical Technology Editors
The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.
Oct 02, 2017
Pharmaceutical Technology
Lawrence Yu, deputy director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), and his FDA colleague, Michael Kopcha highlight the importance of Six Sigma approaches to continuous improvement in the pharmaceutical industry.
Oct 02, 2017
Pharmaceutical Technology
Instead of rigidly applying statistical tools, experts suggest that pharma embrace statistical thinking, but focus on reducing variability and adding value for patients.
Sep 20, 2017
Equipment and Processing Report
Support from FDA, a best practice guide, collaborative research, and new facilities signify progress in solid-dosage continuous manufacturing.
Sep 02, 2017
Pharmaceutical Technology
Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
Sep 01, 2017
Pharmaceutical Technology
Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.
Aug 02, 2017
Pharmaceutical Technology
The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
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