Analytical Considerations For Biopharmaceuticals During Commercialization


To ensure the quality and safety of pharmaceutical drug products, it is critical to validate analytical methods before process performance qualification (PPQ). Furthermore, demonstrating that a product meets the quality expectations of the regulatory bodies requires robust analytical methods that have a high degree of reproducibility and accuracy. This makes analytical process validation a crucial activity for not only product approval, but speed to market. Download this whitepaper to learn more.