Search results for " Lifecycle" in Articles / App Notes
Article
Regulatory Challenges in the QbD Paradigm
Postapproval support through product lifecycle requires high maintenance in the traditional approach. The regulatory burden is high for process changes and, therefore, process improvements are few.
…
Article
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…
Article
ISPE Releases Cleaning Validation Guide
The International Society for Pharmaceutical Engineering (ISPE) has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitione…
Article
Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
The inability to effectively manage process data and knowledge across the product lifecycle is arguably one of the biggest hurdles to progress across the industry as a whole. While this may seem surpr…
Article
The Need for Advanced Process Modeling for New Therapeutic Biologics
What’s more, process modeling can be implemented, and is strongly encouraged, early on in the lifecycle process of product development, as early as the preclinical stages. The modeling approach can al…
Article
Understanding Validation and Technical Transfer, Part 3
… the biopharmaceutical industry discusses validation of a non-traditional biopharmaceutical process, lifecycle and change management, and the benefits of well-conceived and executed process validatio…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
The FDA guidance points to a lifecycle approach to process validation (see Figure 1).
In Part I of this series, the author introduced the concept of continuum of criticality and ap…
Article
Quality by design for biotechnology products—part 1
The QbD approach can be maintained throughout the lifecycle of the product to facilitate innovation and continuous improvement based on expanded knowledge and new technologies. This knowledge is gaine…
Article
Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management
The platform can also formulate risk mitigation strategies for new or existing processes throughout the manufacturing lifecycle. The platform can be customized to meet specific customer needs.
“The…
Article
How To Execute Successful Data Migrations
But that is exactly what they are, and as such, are no less deserving of meticulous planning, rigorous project management, and adherence to a software development lifecycle.
Migration projec…