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 ...

Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses the ...

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle. A crucial step in achieving approval of a biosimilar is establishing analytical and ...

Advancing analytical techniques is all well and good, but unless those advances in technology are accompanied by matching strides in technique management, the true potential of better methods may not ...

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 ...

The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers. The structure and activity of complex biotherapeutic molecules require sensitive ...