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 ...

Time and sensitivity are essential for analytical technologies in all phases of biopharma development. Although just a few decades old, the biopharmaceutical industry has evolved significantly since ...

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 ...

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, ...

With robust, reliable and regulatory-ready analytics lying at the heart of clinically successful cell therapies, now is the time to elevate your current workflows and strategies to prepare for ...

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 ...

The 5th ADC Analytical Development Summit is the only dedicated platform for tackling the unique analytical complexities of ADC development, bringing together technical leaders to ensure a ...

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 ...