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

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...

In the medical device world, laser welding encompasses a wide range of applications and part sizes. However, when laser-welding process cannot be fully verified, FDA requires that manufacturers ...

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 ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Pharmaceutical manufacturing requires defining quality target product profiles and critical quality attributes (CQAs) to ensure desired product quality. Process development identifies critical process ...

As drug development becomes more complex, so do the demands for accurate, reproducible bioanalytical data to prove their safety and efficacy. Method validation ensures the reliability of ...

Variation modeling has evolved over the past several years from a single derating factor that represents on-chip variation (OCV), to Liberty Variation Format (LVF), today’s leading standard format ...