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August 01, 2019
A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.
Using advanced HDX-MS and native MS techniques can improve the identification of potentially successful biologic drugs and de-risk CMC and clinical designs.
Key considerations when searching for an analytical service provider include workflow, hardware, and regulatory support.
July 01, 2019
FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.
June 24, 2019
Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.
June 06, 2019
Cambrex has announced the completion of its new facility at its Karlskoga site in Sweden that combines new laboratories for process and analytical development.
June 02, 2019
Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
May 15, 2019
Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.
Empty and prefilled syringes must pass a range of quality control tests.
May 02, 2019
More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.