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 ...

The past twelve months have culminated in an unprecedented level of excitement, investment, and clinical progress within the gene therapy field. As the field strives to strike a delicate balance ...

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 ...

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, ...

Over the course of the most recent pandemic, vaccine technologies have developed at an amazing pace. However, none of these platforms would have succeeded without comprehensive analytical support. As ...

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 ...

Analytical development is also responsible for generating regulatory submission data for product approval while quality control must generate annual product reviews (APR) under 21 CFR 211.180 (e) or ...

Each department, from production to clinical research, deals with three types of work: maintenance, routine, and project work. The work shares vary with the nature of the work, but all departments ...

Good HPLC methods must satisfy both technical requirements (sensitivity, specificity, linearity, accuracy and precision) as well as business needs (reliability in routine use and a run time ...