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Article NIST Spectroscopic Measurement Standards
NIST Spectroscopic Measurement Standards The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance mea…

Article CoAs Help Secure the Supply Chain
CoAs Help Secure the Supply Chain Certificates of analysis can be used to monitor the reliability of products and their suppliers. By Susan J. Schniepp, distinguished fellow at…

Article Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…

Article Modern Manufacturing Key to More Effective Vaccines
Modern Manufacturing Key to More Effective Vaccines Accelerated development of new preventives raises challenges for efficient CMC evaluation and production. By Jill Wechsler …

Article Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
This week, the Process Development Forum talks with Günter Jagschies, Strategic Customer Relations Leader, Cytiva, about the biopharmaceutical market in Asia.  The Asian market is most often s…

Article Full Single-Use Downstream Process? Not Any Time Soon.
Single-use technologies (SUTs) are here to stay. But where we see full single-use upstream processes, downstream is often a hybrid solution. Here’s why SUTs will not completely replace reuse systems…

Article Applying GMPs in Stages of Development
Applying GMPs in Stages of Development Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, …

Article Navigating Data Integrity in the Modern Lab
Navigating Data Integrity in the Modern Lab The importance of both technology and people in the modern laboratory. By Amber Lowry Understand…

Article Taking Prepacked Columns to Manufacturing Scale
Prepacked chromatography columns in biomanufacturing can save time, but also present concerns related to delivery lead times, capacity, and operational cost. Learn more here about ways to address…

Article Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins. By Adeline Siew, PhD  CA-SSIS/shutterstock.comIm…

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