November 2009

Beer and Elephants

Leaders’ best practices for OPEX
include managing complexity

In his keynote presentation at Discover 2009, Roddy Martin, senior vice president and research fellow at AMR Research, provided an analogy of a circus elephant tethered to a stake at a young age as a traditional training method. When the stake is removed, the adult elephant doesn’t flee, because it thinks it’s still tethered.

“While this is good for the circus, it’s not good for manufacturers that need to move away from procedures and ways of thinking that keep them from moving forward toward Operational Excellence (OPEX),” Martin said. “What I call ‘analysis paralysis’ burdens companies that are limited by their organizational silos and practices. They really need to see themselves from the outside in to understand the whole picture of their challenges and create the continuous improvement culture that’s required for OPEX.”

Martin sees parallels between the beer industry’s deep understanding of QbD and biopharma manufacturers’ goals. Beer has to be drinkable, so brewers must manage their process complexity in a way that not only meets technical and regulatory standards, but differentiates them from competitors even much more advanced ways such as taste. This level of process control and understanding is impressive.

Holistic OPEX Performance Management (Source: AMR Research)

Martin said the ability to manage complex life science manufacturing processes is necessary in order to reach the goals of improved predictability and site optimization, which he believes are the “next level” of process understanding.

“Using applications such as Aegis Discoverant as an architectural component of an Operations Excellence platform, together with Electronic Lab Notebooks, Data Historians, MES, scheduling and other quality and compliance systems, is enabling leaders to start the journey to process and productivity performance improvement that will lead to dramatically changed structural costs without compromising product safety, efficacy, and integrity.”

Click here to watch to Roddy’s presentation >

ROI Metrics

Discoverant users develop
the business case for EMI

One attendee at Discover 2009 noted that in the ‘80s, company managers dictated: “Don’t screw up and don’t run out of products.” In the ‘90s, that changed to: “Look at deviations more closely to improve compliance.” Today, the mandate has evolved to: “Be more efficient.”

But the question for process development and manufacturing teams remains: “How does efficiency translate to ROI?”

To answer that question, one conference workshop focused on how teams can “sell” the value of EMI software within their organizations.

How Life Science Companies Recommend Making the Business Case for EMI:

• Reduce the burden on resources required for analysis, and more analysis can lead to more potential yield and/or higher quality
• Document the time saved for regulatory submissions and reports
• Use examples to demonstrate the value of context – data on its own is meaningless
• Don’t overstate cost savings – inaccurate numbers can distract listeners from the bigger picture
• If the cost of analysis (a.k.a. time) is greatly reduced, more hypotheses can be tested
• Provide numbers for the capital cost of full-time-equivalents (FTEs) vs. the operational cost of changing their roles to make them more effective
• Document and share best practices for obtaining and using data from various source systems
• Research and publish the value of EMI in other industries
• Share industry articles that point to ROI and business benefits

Discoverant User Tips

Getting More from Your
Manufacturing Dashboard

Randy Tatlock, Sr. Applications Manager for Aegis Analytical, shared insight on using Discoverant dasboards for investigations and observation.

By connecting to Analysis Groups (AGs) via ODBC, dashboards can be created that are campaign-centric, product-centric and/or site-centric. Quick and easy access to data from multiple sources provides visibility to data along with “drill-down” and “refresh capabilities” on an interactive webpage in a matter of minutes.   

The following video, “Using Discoverant to Create a Dashboard Portal,” demonstrates how to create an interactive batch-centric dashboard web portal for monitoring Key Performance Indicators (KPIs) and Critical Process Parameters (CPPs) using a display engine such as iDashboards.

Watch the video >

 

Product Update

Discoverant 3.4 Available Soon,
Allows Data Sharing with CMOs

Discoverant 3.4, the latest product update from Aegis, will be available Nov. 16th. Account managers will be in touch with existing Discoverant users to schedule web demonstrations of new product capabilities including:

Data Analysis Engine: InVision/
Analysis Group (AG) Manager

• AG creation - redistribution of the workload among new Windows services
• Defects and defectives – N, NP, U, and C charts available in control charts
• Feature extraction – added R2 for polynomial fit
• Line plots – allowing multiple Y axes
• Enhanced automated result methods that aid in using output from InVision in reports, dashboards and Web applications

Data Aggregation Engines: Hierarchy Manager/Dynamic Mapping Engine

• Optional step nodes – provide the ability to skip step nodes in hierarchies
• View, node and parameter definition pools action are all available from right-click menus in hierarchy Edit tab
• Direct Connect to Web Services allows users to retrieve data from sources that are exposed through Web services

Data Entry

• PRIMR Book Templates may be associated with User Groups to facilitate data entry from or for multiple sites or CMOs

Administration

• New browser-based administration tool simplifies navigation
• Increased memory space for AG Creation and Automated Result Methods (ARM) for higher performance with larger AGs and scheduled jobs
• Users previously associated with domains and system groups can be associated with user roles
• User groups can be configured to associate users with roles
• System settings – all settings are now stored in an embedded database
• Lightweight Directory Access Protocol (LDAP) – Discoverant also supports anonymous binding, OpenLDAP, Apache Directory, and enhanced security with secure socket layer (SSL)

Discoverant Case Study

EMI software simplifies
accounting for batch genealogy

In BioProcess International’s October issue, Justin Neway of Aegis provides a case study that demonstrates how EMI software like Discoverant can improve process knowledge and design through upstream/downstream data analysis.

Article excerpt: “Appropriately designed EMI software helps to understand the influence of upstream process conditions on downstream process outcomes to identify sources of unacceptable variability in downstream critical quality attributes (CQAs). Meaningful correlation can be made between final process outcomes and upstream process conditions without using spreadsheets or other manual methods that can introduce errors. And finally, the lessons learned can be transferred from current processes into future process designs, proactively anticipating the effects of splits and recombinations.”

Read more >

 

Powerful Combination

Discoverant and SIMCA-P+ offer today’s
most advanced tools for sophisticated
multivariate data analysis

For those who need the most advanced multivariate functionality and latent variable analytical capability for chemometrics, the combination of Discoverant and Umetrics’ SIMCA-P+ can reduce volumes of process data into multi-dimensional vectors or scores that can graphically represent a process state and relationships in large data sets. Discoverant and SIMCA-P+ work together to solve complex multivariate problems using latent variable techniques.

Umetrics is offering Discoverant users a 10% discount on a single SIMCA-P+ license.

See offer for more details >

Watch a demonstration of Discoverant
and SIMCA-P+ being used in combination,
working together synergistically >

On the Road
We look forward to seeing you at these
upcoming life sciences industry events:

Informa Life Sciences: Vaccines Europe
Nov. 16-19, Brussels, Belgium

8th Annual World Drug
Manufacturing Summit 2009
Dec. 2-4, Berlin, Germany

Biomanufacturing Summit 2010
Jan. 26-27, San Diego, Calif.

 

Aegis Analytical Corporation • 1380 Forest Park Circle, Suite 200 • Lafayette, CO 80026
303.926.0317 • www.aegiscorp.com • lfairbanks@aegiscorp.com • ©2009 Aegis Analytical Corporation