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June 6th 2025
ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.
Biologics Quality Control: The Growing Need for Accessible Proteomics
There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
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Merck Invests $1.5 Million in TEM Imaging Service Laboratory
February 28th 2008Merck Capital Ventures, a subsidiary of Merck & Co., has invested $1.5 million to expand its service laboratory. The transaction with NanoImaging Services will add high-resolution, three-dimensional transmission electron microscope (TEM) capability, which allows biopharmaceutical researchers to see complex macromolecular structures they create with resolution as high as one nanometer.
The Importance of Leachables and Extractables Testing for a Successful Product Launch
January 2nd 2008FDA’s May 1999 container-closure guidance has accelerated the requirements for extractable and leachable testing of container-closure packaging components. Since that date, additional recommendations have been made by industry groups to clarify how these issues should be addressed.
20th Anniversary Special Feature: The transformation and future trends of laboratory data management
January 1st 2008Historically, the main purpose of laboratory information management systems (LIMS) has been to track and manage samples in the laboratory. LIMS originated nearly 30 years ago as a rudimentary method of automating manual, error-prone processes in the laboratory and, with the growth in adoption of technology, became the de facto benchmark for laboratory control and management.
