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 ...

An overview of trends in gene therapy, the unique analytical challenges posed by developing new treatments, and innovative solutions to address these challenges. Drug development is rapidly evolving, ...

The pharmaceutical industry is starting to apply a Quality by Design (QbD) approach to the development of pharmaceutical products. It follows therefore, that the analytical procedures which are used ...

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 ...

Thought and foresight into method development stages can ensure costly errors and delays are avoided later on. Method development is a critical and continuous process that, if optimized, ensures ...

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

In 2023, industry is witnessing a renaissance in viral vector characterization. Spurred by widespread biopharma investment to engineer a new wave of novel capsids and faced with newly launched QbD ...

Usage: Reference standards serve as quality control benchmarks for equipment calibration and verification of measurement methods and analytical accuracy. Characteristics: Chemicals with established ...