Kemwell Biopharma

Producing biosimilars is quite challenging as drug manufacturers face multiple bottlenecks while ensuring product quality and patient safety. Analytical method development and validation provides the data needed to manufacture safe and valuable drugs. The validation and growth of analytical methods is key to drug development. The biopharma industry has managed to reduce risk by utilising analytical platform technologies for drug conjugates, monoclonal products, and new molecules. In the pharma industry, validation and analytical characterization are mandatory for quality assurance and quality control. Several drug authorities emphasize on the validation of the processes implemented in the industry. Validation is a systematic and formal way to show the appropriateness of the assay method to offer useful data to ensure the process provides consistent and satisfactory results.  The procedure for analytical method development is as follows: 1 . The objective of analyt...