OR WAIT null SECS
February 06, 2019
Radha Iyer, vice-president and head of Quality and Scientific Affairs, Global Developed Markets, Dr. Reddy’s Laboratories, discusses new initiatives at the company.
October 15, 2018
This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.
October 01, 2018
Applied throughout a product’s lifecycle and across a company’s portfolio, quality risk management and knowledge management will enable more agile manufacturing and better quality standards in the future.
September 01, 2018
Andrew Bulpin, head of Process Solutions, MilliporeSigma, shares insights on characterizing CQAs in biopharmaceutical development and the different tests that should be carried out when assessing an investigational drug.
The development and optimization of an efficient conjugation process involves identifying the critical quality attributes and monitoring critical process parameters.
March 01, 2018
Modeling at various stages of the data analytics continuum aids scale comparison of a bioreactor.
February 01, 2018
As closure integrity testing moves from a probabilistic to a deterministic basis, designs are promoting improved control and reduced operator contact.
December 01, 2017
A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.
October 18, 2017
The partnership and the formation of the institute intend to bring together industry, academia, and regulators to tackle challenges and provide solutions for continuous manufacturing.