The Bio-Pharmaceutical manufacturing industry faces new challenges to produce products more efficiently, with better quality. Regulatory requirements are driving an increase in better data collection and management. Because the industry has undergone a major shift from single-product processes to flexible, multi-product facilities, there exists a lag in automation and data integration to make the best use of technology. There is an interdependency between measurement and real-time action for improved process optimization. As processes move from single process steps to more continuous, these islands of data must be tied together through a layer of automation for communication.
Prevailing Issues in the Industry
- Cost of drug development is tied to development time & accuracy of the data
- Majority of research facilities depend on laboratory personnel to gather data (mostly manually) from various instruments, configure the data into a user-friendly format, then begin to analyze the data.
- Each instrument sits on a separate island of automation, making it difficult to observe the data in one easy to view format.
- Most lab related analytical software (JMP/MODDE/ SIMCA/CAMO) are left to the end user to install and create relevant data for their software to analyze.
- Higher throughput devices are generating enormous amounts of data making it difficult for most labs to keep up. Much of the time spent by today’s lab personnel is spent trying to compile and evaluate this data.
In summary – Data Management is a bottleneck – It is difficult, error prone and tedious
There is a Solution for Better Manufacturing
Mystro® Data Management Software is the first end-to-end data management system which can automate, synchronize and collect data from most bioreactors, analyzers and peripheral devices into one central location.
- A unifying software that acts as a bridge to the various instruments or vendors in your lab.
- Only software package which can automatically coordinate all activities pertaining data collection and analysis
- Automated activities include: data collection, real time monitoring, data analysis, reporting, alarming, remote viewing, feedback control, pushing data to ELN, LIMS, DoE software & statistical analysis/MVDA software such as SIMCA, etc.
- Mystro is an excellent tool for both upstream and downstream groups in research, process development and manufacturing.
- Very cost effective solution which saves time, resources, and generates fewer errors than traditional manual methods.
- Provide reliable data to support regulatory compliance.
- Finally, a vehicle where you can make instantaneous decisions with real-time monitoring of all equipment