Advances In Analytical Method Selection And Technology Transfer

By Srinath Kashi Ranganath, staff scientist, field applications, Thermo Fisher Scientific

The growth of biopharmaceuticals makes advanced analytical methods and successful technology transfer essential for product quality and regulatory compliance. Analytical methods consist of three core elements—sample preparation, the assay, and data analysis—and are vital for quality control, regulatory compliance, and process optimization across the entire manufacturing workflow, from raw material to final product testing.

Analytical technology transfer is the systematic process of moving a method from one lab to another, and its success is fundamental for regulatory approval and maintaining production timelines. Common challenges often compromise efficiency, including maintaining data integrity and ensuring protocol standardization and reproducibility across sites. Addressing these issues proactively, often through a gap assessment of personnel, equipment, and environmental factors, is critical.

Adopting best practices, such as comprehensive documentation, clear Standard Operating Procedures (SOPs), and effective training, helps mitigate risks like production delays and compliance penalties. Learn more about effective strategies and how commercially available solutions can streamline your analytical method transfer process by downloading the full application note.