Newsletter | September 16, 2021

09.16.21 -- The 5-Step Checklist For A More Mature, Robust Quality Management System

 
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Managing Frozen Transport Logistics In The Biopharmaceutical Cold Chain

As biopharmaceutical manufacturing grows increasingly global, the production and transport networks required to keep operations running smoothly become more complex. This paper provides a framework for making challenging decisions linked to cold chain management before outlining potential solutions that could solve many of the issues surrounding the frozen transfer of biopharmaceuticals.

Analytical Services: Risk Management In PFS Components Selection For Sensitive Biological Drug Formulations

Choosing the right containers and materials is critical but difficult, and no methodology can quickly assess the risk of drug/device interaction. Two risk-based test methodologies help to select the optimum closure materials and the correct syringe silicone level at the earliest phase of drug development.

Tips For Purifying Cryo-EM Samples

Cryo electron microscopy (cryo-EM) can help you determine structures for challenging proteins such as membrane proteins and larger complexes. Check out our presentation for tips on purifying your cryo-EM samples.

How To Use Quality By Design (QbD) Software To Improve An Existing Identification Method
What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a quality by design (QbD) approach.
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