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January 23, 2018
The funding from the Walloon Region will enable Univercells to start developing a manufacturing platform aimed at driving down costs of biosimilars manufacturing.
December 19, 2017
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.
October 02, 2017
Instead of rigidly applying statistical tools, experts suggest that pharma embrace statistical thinking, but focus on reducing variability and adding value for patients.
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.
September 20, 2017
Support from FDA, a best practice guide, collaborative research, and new facilities signify progress in solid-dosage continuous manufacturing.
September 02, 2017
Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
September 01, 2017
Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.
August 02, 2017
Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.
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.
July 26, 2017
Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.