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 ...

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 ...

High Performance Thin Layer Chromatography (HPTLC) is a powerful method equally suitable for qualitative and quantitative analytical tasks. Applications of HPTLC, such as identification and ...

This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods. About a decade ago, FDA and other regulatory agencies introduced a series of ...

Expansive growth in the gene and cell therapy (GCT) space has led to developers and manufacturers facing a multitude of challenges on the road to commercialization. To overcome issues associated with ...

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 purpose of this course is to provide candidates with some practical tools for validation - including qualification, process validation and analytical method validation. Validation is a regulatory ...

BOCA RATON, Fla.--(BUSINESS WIRE)--LGM Pharma today announced the launch of its new Analytical Services offering that provides analytical testing and stability services to pharmaceutical developers ...

The challenges of vaccine development are not limited to identification of suitable antigens, adjuvants and delivery methods, but include regulatory, technical and manufacturing hurdles in translating ...

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 ...