Discoverant in Action
How Eli Lilly Exploits Data to Transform
Manufacturing using OSI PI and Discoverant
Manufacturers have always been challenged to do more with less. For life science companies, this includes leveraging existing IT investments to improve process predictability and yield. In this presentation, Eli Lilly discusses how they extend the value of their investment in OSIsoft by integrating it with other third-party systems such as Discoverant to gain process understanding. As a result, Eli Lilly maintains a leaner supply chain and accelerates the release of new products to the market.
Click to see Eli Lilly’s presentation
Merck Serono’s Design Considerations for a Biological Process Development Implementation of Discoverant
Merck Serono established the following requirements for new production processes at its Biotech Center in Vevey, Switzerland:
- Efficient process data management platform for data entry and retrieval
- Easy access to process genealogy in order to make upstream/downstream correlations
- Technology transfer from process development to manufacturing sites
- Ability to make batch-to-batch and site-to-site comparisons
Click to read more about Merck Serono’s evaluation and use of Discoverant in process development
How Eli Lilly Uses Discoverant to Achieve Manufacturing Excellence
Aegis’ Justin Neway and Randy Tatlock (formerly of Eli Lilly) explain the need for on-demand data access, aggregation and analysis in achieving process excellence. This presentation, extracted from the Seventh Annual Biological Production Forum in Munich, describes Eli Lilly’s global roll-out of Discoverant and their requirements to:
- Leverage existing IT investments
- Employ standards-based interfaces to get data
- Address current business and regulatory needs
- Provide users with a single, validatable system to access, analyze and report data
Click to see the presentation
Improving Process Predictability Across Multiple Plants
A multinational pharmaceutical company needed to improve process predictability for two of its blockbuster products. Production of each product took place in multiple manufacturing facilities in different countries. The company used Discoverant to identify the causes of process variability in spite of having to work with processes and data that spanned multiple plants.
Click to see the full case study
ROI: The Strong Case for EMI Software
Understanding how EMI software creates efficiencies across manufacturing, process development and IT is critical to helping management embrace its adoption. The following example illustrates the pay-back from EMI software used to improve process performance.
A manufacturer uses Discoverant to support a Design of Experiments (DOE) project to identify cause/effect relationships between yield and input variables. A DOE team identifies the significant process variables that can have a positive impact on yield and identifies new, valid operating ranges for these process variables, which can drive yield increases. It deploys Discoverant to validate process repeatability and to monitor that the process maintains the new state of control. With a five percent increase in production achieved through enhancements to an existing process, many sites are able to realize tens of millions of dollars in savings and benefits including:
- Staffs have more time to work on other high-value activities
- Self-service data access for manufacturing users means fewer demands on IT staff, which are free to work on other projects
- Reduced process variability enables reduced inventory that is typically stock-piled to avoid stock outs.
- Improved supply chain predictability and reliability
- Better understanding of process parameter relationships reduces the number of regulatory investigations and saves time for regulatory responses
- Improved technology transfer and accelerated scale-up speeds time-to-market for new products
- Improved collaboration with colleagues at other sites facing similar challenges
- Better process understanding reduces potential batch failures
Read more about the ROI of EMI in an article by Aegis President and CEO, Robert Di Scipio, in the March 2010 issue of Next-Generation Pharmaceutical.
Enabling Process Understanding, Continuous Quality Verification & Real-Time Release
Although the business case for real-time release is still evolving, it continues to draw the interest of life sciences manufacturers. It is important to monitor the path that leads us to that end – keeping in mind that it could be a decade-long journey for some.
See the full article by Aegis’ Dr. Justin Neway in Pharmaceutical Processing
Training Corner
Aegis offers extensive, hands on training to help users realize the immediate benefits of Discoverant upon implementation. These classes are designed to help you understand everything from the basics of navigation to hierarchy administration. Course offerings include; Hierarchy Development, System Administration, Basic User Training, Advanced User Training, PRIMR Developer and Administration and PRIMR User.
Highlights of our technical training include:
Hierarchy Development
Hierarchy Development is designed to provide new hierarchy developers the ability to create basic hierarchies representative of their manufacturing or product development processes. Students will gain an understanding of the data modeling process, including hierarchy outlines, data definitions, data view creation and the identification of analytical goals.
System Administration
Discoverant System Administration is designed for the individual responsible for installing and maintaining the Discoverant system. Standard administrative tasks like backups and troubleshooting are covered, along with technical configurations like setting up LDAP.
Discoverant’s eLearning solutions…(coming soon)
Discoverant’s virtual classroom will bring top classroom features to you – anytime, anywhere. Each class is self-paced and the learning sessions will be available 24x7.
Begin your journey with Feature Extraction coming Q2 2010. Feature Extraction offers users the ability to extract features from specific regions of continuous data parameters for each batch or group of batches - variability, area under the curve, polynomial curve fit, slope, mean, minimum, maximum, etc., using an intuitive point-and-click graphical interface. The extracted features are converted to numerical quantities and saved so that they can be used alone or in combination with other process parameters from other data sources (e.g., process outcome data from LIMS) for statistical and graphical analyses including multiple regression and trending.
For a demonstration of Discoverant’s Feature Extraction capabilities click here
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