Search results for "Analytical data"

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 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 Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation. Design of experiments (DOE) is a well-proven characterization approach within product…

Article Tools for Enabling Process Analytical Technology Applications in Biotechnology
The success of process analytical technology (PAT), a recent initiative by FDA, depends to a large extent on efficient control of manufacturing processes to achieve predefined quality of the final p…

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 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…

Resource Controlling Cell Culture Process Variability Through Supplier-Enabled Data Management and Analytics
Controlling Cell Culture Process Variability Through Supplier Enabled Data Management and Analytics

Resource Controlling Cell Culture Process Variability Through Supplier-Enabled Data Management and Analytics
In drug development and manufacturing, variability in raw materials presents high risks to the success of processes and products. When raw material variability issues arise, manufacturers and supplier…

Article Controlling Cell Culture Process Variability Through Supplier-Enabled Data Management and Analytics
In drug development and manufacturing, variability in raw materials presents high risks to the success of processes and products. When raw material variability issues arise, manufacturers and supplier…

Article Analytical SEC: How Does Back Pressure Relate to Resolution?
High resolution in HPLC is not achieved by applying back pressure to the column. Let’s straighten out what really helps you achieve high-resolution analytical SEC data. Read paper

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