Anthem BioPharma | Anthem Cellutions

Method Development & Validation

Anthem has the vast experience and varied expertise in analytical chemistry to offer efficient, accurate and reliable services, which can be tailored to specific customer needs.

With our wealth of experience in method development, optimization and validation we have delivered a wide range of successful pharmaceutical, healthcare, nutraceuticals and polymer chemistry projects.

Working closely with our clients, we develop, optimize and validate robust transferable methods across a broad spectrum of sample matrices (Drug Substance and Drug Product).

• Methods are validated as per ICH guidelines and also as per customer requirement
• Anthem is flexible in adopting and validating methods developed in-house, client developed methods or any compendial methods
• Anthem is capable of conducting Forced degradation studies as a part of method development and validation in both solid state and liquid state
• Anthem also has the capability of developing methods for Genotoxic impurity quantification, leachables/ extractables.
• We also offer validation of classical and physical testing techniques includingmanual titrations and potentiometric titrations.