Translating scientific concepts into validated routine assays for continuous quality control of expression systems and production processes is one of the core competences of Glycotope’s analytical services.
Glycotope has a proven track record in customized bio-analytical method development, qualification, validation and routine application. Its facilities, including equipment and instrumentation, are certified under good control laboratory practice, GCLP. Our analyses and reports are accepted by regulatory authorities worldwide. In addition, Glycotope offers a comprehensive validation program in accordance with ICH Q2A (R) guidelines. The validation data can be reviewed at our facility in the context of a client audit. To ensure consistently high quality, our quality assurance systems are regularly audited.
Glycotope’s Analytical Services can help customers with immediate support for specific biological assay development at any point along the product development path. We provide full GMP-compliant analytical services and work together with our clients to develop and set-up efficient first-class quality control management to ensure the highest product quality and to help reduce the overall time and cost of product development.