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.

Identify PQAs

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.

Track and Quantify PQAs

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.

Monitor Known Impurities

Simplify analytical complexities with confident identification, monitoring, and flagging of known impurities, such as residual Protein-A, cell culture contaminants, or host cell proteins.

Purity Testing with New Peak Detection

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.

Customer Case Study

Learn how Sanofi uses the X500B QTOF System and BioPharmaView Software to increase analytical throughput during monitoring of manufacturing batches

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. Experience accurate and reproducible PQA monitoring, attribute ratio calculations and quantitation, known impurity tracking and unspecified impurity testing using New Peak Detection algorithms.

ExionLC™ AD

Delivers high accuracy, reliability, and repeatability across thousands of injections, with maximum uptime

X500B QTOF System

Accurate and robust biotherapeutic analysis on the compact and easy-to-use QTOF System with intuitive point-and-click SCIEX OS acquisition software

TripleTOF® 6600

Gain ultimate flexibility to do comprehensive characterization, quantitation and high throughput comparability studies on the powerhouse accurate mass platform

BioPharmaView™ Software

Perform streamlined MAM Workflow data processing all in a single software solution, along with core biologics characterization analyses.

Technical Note

Application of the MAM Workflow in BioPharmaView™ Software 3.0

Brochure

Multiple Attribute Methodology (MAM) for Biotherapeutic Attribute Monitoring and Purity Testing

Executive Brief- X500B

Multiple Attribute Methodology (MAM) by LC-MS

Executive Brief- TTOF 6600

Multiple Attribute Methodology (MAM) by LC-MS

 

See More in Biologics Characterization
 
Solution Guide: Intact Mass Analysis Download
Solution Guide: Peptide Mapping Analysis Download
Video- Introduction to the X500B QTOF System for Biologics Watch
Biotherapeutic Analytical Characterization eBook Download
Technical Note- Peptide Mapping of Biotherapeutics with SWATH Acquisition Download