Multi-Attribute Method (MAM) is a powerful approach that increases the efficiency of biopharmaceutical development through the implementation of Analytical Quality by Design (AQbD) principles throughout the product lifecycle. AQbD, if you’re new to it, takes a structured approach to the development of analytical procedures designed for a specific purpose and that consistently deliver results that meet predefined objectives.
It achieves this through a detailed understanding of all aspects of the analytical methods performance. This ensures adequate control and an ability to react to changes that can affect the quality of results. AQbD for MAM—around for 15 years — is nothing new, however, challenges still surround biotherapeutic analytical development. These challenges include: software compliance and connectivity, method ease of use and critically application-specific training and support to streamline the transition from the development of your biotherapeutic to quality control.
An end-to-end MAM solution
Thermo Scientific™ MAM 2.0 is an end-to-end MAM solution that delivers consistent and high-confidence results with operational simplicity; it seamlessly connects instruments, people and labs for enhanced collaboration — from development to QC. For development workflows it allows confident product quality attribute (PQA) identification and quantification, sensitive new peak detection using industry-proven Thermo Scientific™ Orbitrap™ technology, ultra-high-resolution, excellent mass accuracy and dynamic range to resolve overlapping peaks and obtain accurate peak integration. The intelligent data processing algorithm in BioPharma Finder™ software also minimizes false positive and negative results. The ease of data management is enabled by a fully integrated enterprise data system, allowing you to automatically save data and results in a secure central data storage that can be remotely accessed from any authorized network computer. You can also easily share your instrument and processing methods with colleagues for enhanced collaboration while meeting regulatory requirements — without sacrificing efficiency.
Improve confidence and productivity on a MAM platform designed for QC
MAM 2.0 also was designed to meet the unique challenges of QC environments, delivering consistent, robust performance and operational simplicity within a single compliant enterprise data system. Accurate and consistent critical quality attribute (CQA) monitoring and new peak detection are ensured by industry-proven Orbitrap technology, now purposely designed for QC with robust and consistent unit-to-unit performance.
Ready to learn four ways to accelerate biotherapeutic development?
1. Experience this workflow for yourself in our new 3D virtual MAM lab tour that takes you on a journey from the development of your biotherapeutic right through to quality control.
2. Visit our website for the latest information on MAM.
3. View this application note, which describes the MAM 2.0 system evaluation test
4. View this application note, which describes the MAM 2.0 workflow.
