Merck has announced the launch of BioReliance Product Characterisation Portfolio; a range of tests for quality assessment of biologic drugs.
This new, comprehensive suite of tests provides critical information that biologic manufacturers need as they design their production process.
The purity, safety and efficacy of a drug must be identified and continuously monitored to support development and meet regulatory requirements necessary for commercialisation.
Manufacturers can better understand their molecule’s function, through comparison of structure and activity, helping them to make critical decisions.
This portfolio of assays enables the characterisation of mAbs, including physicochemical and immunochemical properties, biological activity, stability, and purity as outlined in the ICH Q6B guidelines, as well as EMEA and FDA regulatory requirements.
In addition, specialised capabilities, such as hydrogen-deuterium exchange technology and highly sensitive surface plasmon resonance instrumentation, are available.
Merck’s experienced team is prepared for all testing needs, along with the ability for GMP validation as needed.
Merck is deemed a provider of the industry’s most comprehensive portfolio of high-quality products, services, and testing for biopharmaceutical manufacturing. BioReliance services offer risk-mitigating approaches, critical testing services and customised solutions to help bring life-changing therapies to market.