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 ...

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 ...

As access to faster and higher-throughput analytical methods becomes increasingly vital, it is critical that we employ superior analytical approaches for mRNA-based therapeutics and vaccines to ensure ...

With RNA technologies receiving the Nobel Prize two years running, we are witnessing the mRNA industry make great strides as optimized analytics, critical quality control methodology and robust assay ...

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, ...

CRISPR-based therapies are undergoing a remarkable evolution, with drug developers striving to enhance the safety, precision and efficacy of their products. As this paradigm takes place, more complex ...

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 ...

The updated ICH Q14 guidance from the FDA revising analytical procedures used for release and stability testing has shown higher product quality expectations from regulatory agencies. As analytical ...

The 2nd Cell Therapy Analytical Development Summit Europe is an unmissable event for Europe's top biotech and pharma! As the cell therapy industry continues to rapidly grow and evolve, the opportunity ...