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October 24, 2019
Best Practices for Selecting a Top-Quality Cell Line
Leveraging automation and a step-by-step approach are keys to success. Cell lines determine the...
June 20, 2019
Moving PAT from Concept to Reality
Process analytical technology (PAT) is applied in the biopharmaceutical industry for analysis of raw...
March 19, 2019
An Analytical Approach to Biosimilar Drug Development
The long-term safety and efficacy of biosimilars are largely based on clinical studies that have...
April 12, 2018
Understanding Validation and Technical Transfer, Part I
Many new biological entities use unique processing flows and steps that can require non-traditional...
January 18, 2018
What’s in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp...
November 16, 2017
Evaluating Surface Cleanliness Using a Risk-Based Approach
Regulated companies that use automated cleaning applications have always struggled with correlating...
September 21, 2017
Bioburden Control in the Biopharmaceutical Industry
The biopharmaceutical industry has witnessed tremendous breakthroughs during the past few years. However, this advancement...