Although just a few decades old, the biopharmaceutical industry has evolved significantly since its inception. Many candidate biologics today-antibodies and antibody fragments, highly potent ...

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with ...

This field has evolved considerably through the integration of systematic design strategies, notably the incorporation of Analytical Quality by Design (AQbD) principles and robust statistical tools ...

DS InPharmatics Head of Analytical Services, Colman Byrne joins the show to share his experience in analytical method development and validation. Colman is the most senior analytical services expert ...

Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability ...

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...

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 ...

VANCOUVER, BC / ACCESS Newswire / September 29, 2025 / Onco-Innovations Limited (CBOE CA:ONCO)(OTCQB:ONNVF)(Frankfurt:W1H)(WKN:A3EKSZ) ("Onco" or the "Company") is pleased to announce that ...

Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability ...