The multi-attribute method (MAM) is a powerful approach that increases the efficiency of biopharmaceutical development. This mass-spectrometry-based technique allows the extraction of a large number of different quality parameters of a protein within a single analytical approach.
Process observation, gathering of data, differentiation and interpretation are basic steps in biopharmaceutical development. As the complexity of biotherapeutics increases continuously, the standards for analytical assays designed to provide the required data and high-quality insights are increasing as well. The multi-attribute method (MAM) has the potential to replace conventional approaches and to reduce the development time span while simultaneously increasing the quality of the information obtained. Peptide-mapping with quantitative LC-ESI-MS provides specific, structurally resolved information on quality attributes, such as truncation, isomerization, deamidation, oxidation, glycation and glycosylation in a single analysis.
Come to a Deeper Understanding
Low-resolution MS techniques have lower specificity and are unable to determine some critical modifications, especially when there are no chromatographic differences in modified and unmodified peptides. Digesting proteins into peptides which are then monitored meticulously, the MAM workflow, based on high resolution and accurate mass techniques, not only provides a multitude of data in a comparatively short time, but MAM is also highly beneficial for a deeper understanding of the manufacturing process and supports the following steps in biopharmaceutical research and development:
- Lead candidate selection
- Production clone selection
- Production process optimization
- Extended characterization
- Release and stability testing
Gain Detailed Knowledge in One Fell Swoop
Classical HPLC methods are able to show differences in sample profiles but the detailed information tends to depend on where they are derived from. MAM enables highly accurate relative quantification of molecular details through peptide mapping and focuses as much on the what as on the why by giving answers to the question of what a difference consists of on the molecular level. "The MAM workflow permits detailed search for components referring to a large variety of critical quality attributes,“ says Business Development Manager Marcus Mreyen. „The information gathered not only gives information on modifications that occur due to specific intentional changes within the process development but it also provides evidence about the exact location of modifications and thus gives insights into the structure-function relationship of biopharmaceuticals.“ The influence of the manufacturing process on the biopharmaceutical can therefore be revealed to a very detailed degree.
Save Time, Be More Efficient
Time-to-market pressure is the driving force behind every approach in the development of biopharmaceuticals. Exceedingly high development demands emphasize the need to ensure that existing methodologies are as efficient as they can be. With Protagen Protein Services at your side you will have the most reliable partner, one with two decades of experience in the field of MS techniques and the most up-to-date backing computational life-science tools. We ensure a comprehensive approach, rapid evaluations of data and well-structured summaries of observations and results.
We will be happy to partner with you.