Automated Software-Driven MAM Implementation for Biotherapeutic Characterization
Customer Company Size
SME
Region
- America
Country
- United States
Product
- Genedata Expressionist
Tech Stack
- Liquid Chromatography-Mass Spectrometry (LC-MS)
- Multi-Attribute Method (MAM)
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Productivity Improvements
- Innovation Output
Technology Category
- Analytics & Modeling - Big Data Analytics
Applicable Industries
- Pharmaceuticals
- Healthcare & Hospitals
Applicable Functions
- Quality Assurance
- Product Research & Development
Use Cases
- Predictive Quality Analytics
Services
- Data Science Services
About The Customer
Just Biotherapeutics is an integrated design company that focuses on technologies that will accelerate the development of biotherapeutics and substantially reduce their manufacturing cost. The company is based in Seattle, Washington, USA and has been a customer since 2017. Just Biotherapeutics is part of the MAM consortium, which includes biotherapeutic manufacturers, instrument and software vendors, and government agencies in the USA (NIST and the FDA) and Japan. The goal of the consortium is to enable the BioPharma community to implement a robust mass-spectrometry-based method for biotherapeutic characterization and release of biotherapeutics from QC.
The Challenge
Just Biotherapeutics faced several challenges in analyzing biotherapeutics using mass spectrometry-based methods. The large amount of data generated by comprehensive in-depth characterization was a major challenge, as it required frequent analysis of various samples and large-scale studies. Current solutions often relied on multiple software packages and manual transfer, making data processing and analysis a major bottleneck in the biopharmaceutical development process. Additionally, the richness of MS data often led to the generation of large numbers of false-positive identifications, which had to be manually investigated, a process that was typically laborious and time-consuming. MAM monitoring systems also needed to deliver efficient, reproducible, and reliable detection of new or unexpected peaks. Lastly, the development and manufacturing of biopharmaceutical molecules generated data from a multitude of sources, requiring a data system that could manage and collate large amounts of disparate data.
The Solution
Just Biotherapeutics implemented Genedata Expressionist, a software that processes and analyzes data from any MS instrument using fully automatable and configurable workflows. The software uses metadata to directly apply specific parameters to individual data sets at any step, offering complete control over each experiment while boosting productivity by increasing throughput and eliminating laborious manual intervention. Genedata Expressionist workflows are highly flexible and are designed to automate processes specific to each user. Each step of the workflow can be controlled by user-definable settings, offering an unparalleled level of control during MS data processing. For example, signals can be filtered according to their intensity, charge, or presence in a given proportion of samples. This provides an efficient method for reducing the number of false-positive identifications, while ensuring that genuine contaminants are not overlooked. The software also takes all available MS data into account during MAM new peak detection, greatly increasing the likelihood that unexpected contaminants and product variants are detected.
Operational Impact
Quantitative Benefit
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