02.25.21 Developing Future Delivery Models For ATMPs
Seeq is hosting a live virtual event featuring pharmaceuticals and life sciences experts from Eli Lilly, Lonza, Amgen, and more on March 10, 2021. Mark your calendars and register to hear how other companies in your industry are using advanced analytics technology to turn their data into insights, drive process improvement, and increase profitability.
This is a live event, and the presentations will not be accessible afterward. Save your spot today spaces are limited!
Featured Editorial
By Erich H. Bozenhardt and Herman F. Bozenhardt
With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial manufacturing as they weigh s
EU GMP Annex 1 Insights
By Frank Panofen, PH.D., Maurizio Della Pietra, Daniele Pandolfi, Anna Campanella, Giulia Artalli, and Paola Lazzeri
The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity referenced multiple times. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are interwoven into each section.
In the Principle section (Section 2), the guidelines indicate risk assessments should be performed for each area to ensure they are optimized, validated and qualified. Quality objectives are set and fulfilled through the implementation of quality assurance (QA) systems. These systems are controlled via scientific evaluation of risks in accordance with quality risk management (QRM) principles. Monitoring devices provide the reliable, actionable data n