Search results for " process analytical technology"

Article The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…

Article Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals. The manufacture of biopharmaceuticals presents …

Article Tackling Analytical Method Development for ADCs
Feb 01, 2015 By Cynthia Challener, PhD BioPharm International Volume 28, Issue 2 The targeted therapy possible with antibody-drug conjugates (ADCs) makes them an attractive class of …

Article An Analytical Approach to Biosimilar Drug Development
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars. By Feliza Mirasol …

Article Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 4 Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …

Article Being Thorough When Transferring Technology
Recent advances in analytical tools—like process analytical technology (PAT) and advances in protein characterization—have led many to question whether the process-defines-the-product approach can be …

Article Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption. By Cynthia A. Challener alexlmx a- Stock.Adobe.com Process analytical technology (P…

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Control strategies such as process analytical technology (PAT) may be allowed for better control, a reduced NOR and, therefore, reduced variation relative to its PAR. A lower likelihood (occurrence) o…

Article QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…

Article 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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