Mass Spectrometry Multi-Attribute Method for Biopharma Characterization
Mass Spectrometry Multi-Attribute Method (MAM) for Biopharma Characterization
Streamline Analysis and Enhance Detection with LC-MS Multiple Attribution Monitoring
Multiple analytical assays are currently used for product quality attribute (PQA) monitoring and product purity testing throughout biotherapeutic development and production. As regulatory requirements continue to evolve and expand, researchers are increasingly pressured to provide more detailed information on the biologic product, while speeding development times.
A Multiple-Attribute Methodology (MAM) using accurate mass LC-MS can directly monitor more PQAs in a single sample analysis than other conventional characterization methods. Using a single MAM LC-MS assay can reduce the overall analytical testing burden during development while gaining a more complete analysis of the product quality profile.
The SCIEX streamlined Workflow for MAM utilizes powerful, accurate mass QTOF technology and BioPharmaView™ Software 3.0 for PQA monitoring, while concurrently monitoring known impurities and detecting new, unspecified impurities. This single software solution makes developing and implementing a MAM LC-MS assay simple and intuitive to do while enhancing the characterization of your biotherapeutic.
A Complete LC-MS Workflow for MAM
Streamline Biotherapeutic Monitoring
It’s time to accelerate biotherapeutic development by putting powerful mass spec capabilities into the hands of all analytical scientists
Direct Detection of Product Quality Attributes
Directly detect and measure biologically relevant attributes using LC-MS
Get increased confidence using an orthogonal assay in process development and product release
Simplify Method Development and Method Transfer
Develop a robust and reproducible MAM Workflow on the high-performance TripleTOF® 6600 system, or on the user-friendly and compact X500B QTOF System with the intuitive SCIEX OS user interface
Easily transfer MAM processing methods to downstream labs for faster workflow implementation using BioPharmaView Software 3.0 capabilities
Accelerate Testing Workflows
Product quality attribute (PQA) definition, tracking, and quantification; detection of known and unknown impurities; and reporting- all in the new BioPharmaView Software 3.0
Accelerate your time to answers by using a single processing software, instead of moving data between multiple programs to get all your answers
Expedite attribute characterization and simplify MAM method development with SWATH® data-independent acquisition. Get truly comprehensive and unbiased data collection for a more complete understanding of your biotherapeutic. Focus on the data that matters most to you with the intuitive and easy-to-use filtering options in the BioPharmaView Software.
Build attribute tracking lists and customized calculations to accelerate and simplify data comparisons between LC-MS and conventional characterization assays. Quickly build powerful attribute acceptance criteria with upper and lower acceptable boundaries for each attribute.
Accelerate your development process with this streamlined approach to screening for unspecified impurities that may be present in a biotherapeutic product. In the same sample analysis used for PQA tracking and quantitation, get a confident and sensitive screen for the presence of any new components by using new peak detection algorithms.
Complete and Streamlined MAM Workflow with SCIEX Accurate Mass Technology
This solution is perfect for analytical development labs looking to develop and implement a powerful, yet simple, accurate mass LC-MS based Multiple-Attribute Methodology (MAM) workflow for biotherapeutic product quality attribute (PQA) monitoring and quantitation.
Accurate and reproducible PQA monitoring
Attribute ratio calculations and quantitation
Known impurity tracking
Unspecified impurity testing using New Peak Detection algorithms
Delivers high accuracy, reliability, and repeatability across thousands of injections, with maximum uptime