Download PDF
Automated Software-Driven MAM Implementation for Biotherapeutic Characterization
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
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.
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 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
Related Case Studies.
Case Study
Case Study: Pfizer
Pfizer’s high-performance computing software and systems for worldwide research and development support large-scale data analysis, research projects, clinical analytics, and modeling. Pfizer’s computing services are used across the spectrum of research and development efforts, from the deep biological understanding of disease to the design of safe, efficacious therapeutic agents.
Case Study
Hospital Inventory Management
The hospital supply chain team is responsible for ensuring that the right medical supplies are readily available to clinicians when and where needed, and to do so in the most efficient manner possible. However, many of the systems and processes in use at the cancer center for supply chain management were not best suited to support these goals. Barcoding technology, a commonly used method for inventory management of medical supplies, is labor intensive, time consuming, does not provide real-time visibility into inventory levels and can be prone to error. Consequently, the lack of accurate and real-time visibility into inventory levels across multiple supply rooms in multiple hospital facilities creates additional inefficiency in the system causing over-ordering, hoarding, and wasted supplies. Other sources of waste and cost were also identified as candidates for improvement. Existing systems and processes did not provide adequate security for high-cost inventory within the hospital, which was another driver of cost. A lack of visibility into expiration dates for supplies resulted in supplies being wasted due to past expiry dates. Storage of supplies was also a key consideration given the location of the cancer center’s facilities in a dense urban setting, where space is always at a premium. In order to address the challenges outlined above, the hospital sought a solution that would provide real-time inventory information with high levels of accuracy, reduce the level of manual effort required and enable data driven decision making to ensure that the right supplies were readily available to clinicians in the right location at the right time.
Case Study
Gas Pipeline Monitoring System for Hospitals
This system integrator focuses on providing centralized gas pipeline monitoring systems for hospitals. The service they provide makes it possible for hospitals to reduce both maintenance and labor costs. Since hospitals may not have an existing network suitable for this type of system, GPRS communication provides an easy and ready-to-use solution for remote, distributed monitoring systems System Requirements - GPRS communication - Seamless connection with SCADA software - Simple, front-end control capability - Expandable I/O channels - Combine AI, DI, and DO channels
Case Study
Fusion Middleware Integration on Cloud for Pharma Major
Customer wanted a real-time, seamless, cloud based integration between the existing on premise and cloud based application using SOA technology on Oracle Fusion Middleware Platform, a Contingent Worker Solution to collect, track, manage and report information for on-boarding, maintenance and off-boarding of contingent workers using a streamlined and Integrated business process, and streamlining of integration to the back-end systems and multiple SaaS applications.
Case Study
Driving Digital Transformations for Vitro Diagnostic Medical Devices
Diagnostic devices play a vital role in helping to improve healthcare delivery. In fact, an estimated 60 percent of the world’s medical decisions are made with support from in vitrodiagnostics (IVD) solutions, such as those provided by Roche Diagnostics, an industry leader. As the demand for medical diagnostic services grows rapidly in hospitals and clinics across China, so does the market for IVD solutions. In addition, the typically high cost of these diagnostic devices means that comprehensive post-sales services are needed. Wanteed to improve three portions of thr IVD:1. Remotely monitor and manage IVD devices as fixed assets.2. Optimizing device availability with predictive maintenance.3. Recommending the best IVD solution for a customer’s needs.
