Search results for " lifecycle management"
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Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry.
By Jennifer Markarian
The implementation of sing…
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Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
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Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
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Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…
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Maximum Output Starts with Optimized Upstream Processing
By Cynthia A. Challener
Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity.
Significant growth in the develo…
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Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management
“Our collaboration with Cytiva will provide their customers with an automated, systematic, and user-friendly approach to risk management that will improve lifecycle management of cell and gene therapi…
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Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control
The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…
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Avoiding Investigational Failures and Discrepancies
Avoiding Investigational Failures and Discrepancies
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
By Walt Murray,…
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Remote Monitoring and Big Data Advance Upstream Automation
A key component of those solutions, adds Chris Sandusky, director of automation solutions and product and lifecycle management for Cytiva, is more effective data management that allows for simpler, da…
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How To Execute Successful Data Migrations
Successful migrations require careful planning to meet business needs and maintain data integrity.
By Art Meisler
Data migration is the unglamorous task of a system implementation. …