USP recognizes CryoTEM for characterizing empty/full/intermediate capsids on AAV8 reference standards STOCKHOLM, ...
Intimate Connectivity Must Be Maintained Throughout the Product’s Lifecycle The link between product specifications and analytical methods throughout a product’s lifecycle makes intuitive sense. One ...
The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...
In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...
Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating ...
The devices around us that generate and store the energy that powers our electronics and propels our vehicles rely on intricate chemistry that often happens in tiny spaces. But those ...
Nitrile and latex gloves that scientists wear while they are measuring microplastics may lead to a potential overestimation of the tiny pollutants, according to a University of Michigan study, ...
The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on ...
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