Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

Mars, Incorporated, working in partnership with AOAC International, has successfully completed a multi-laboratory, first-of-its-kind validation of a method for analyzing flavanols and procyanidins in ...

The last two decades have witnessed the steady growth of the protein drug market. As original recombinant products come off patent, generics/ biosimilars are also beginning to be manufactured. The ...

Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, ...

Cannabis laboratory employee turnover is common, extraordinarily expensive, time consuming, and risks harming internal culture. Surprisingly, most cannabis laboratories are unaware of an extensive ...