Streamline analytical characterisation for biotherapeutics with the Multiple-Attribute Monitoring (MAM) approach

Critical Quality Attributes (CQAs) are typically defined early in development based on the quality target profile of the product. The complexity of the CQAs calls for the development of many different analytical methods. The Multiple-Attribute Monitoring (MAM) approach allows for a reduction of this analytical complexity by replacing numerous Single Attribute Testing for Product Attribute Control and release. This approach is mainly used during product development, but could also be used for release testing and stability studies.

Research areas

At Quality Assistance, our dedicated teams are developing MAM methodologies that utilise LC-MS technology for the assessment and monitoring of CQAs. They focus on the development of robust methods that could eventually be transferred to other labs, using GMP-compliant solutions for the whole workflow. A particular attention is paid to the validation of such methods.

Our research approach focuses on:

• CQAs assessment

• Customised method development

• Variability control of MS detection

• Method application using Mass Spectrometry

• Method validation

• Demonstration of proof of concept on model compounds

Customised solutions

For each client project, we define analytical protocols, develop and validate specific new (bio)analytical methods and perform testing in order to evaluate the Quality, Safety and Efficacy of the given drugs.

Thanks to our thorough regulatory, scientific and technical monitoring and skilled teams, we commit to providing the highest quality services and generating reliable data to enable our clients to consistently market safe products.

Speed up the development of your product. Contact us for more information.