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Q3­ 2008


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Archived Issues

Q2 2008

Stability and
Expiration Dating

Have you ever run into a situation where you needed to understand stability trends – such as dissolution, pH or potency - in your batch or lot, over time and under different conditions?

Download a demonstration of Stability and Expiration Dating module to see how Discoverant decreases the time and increase the reliability of your next stability analysis.

INDUSTRY INSIGHT
Industry Collaboration Delivers Best Insight
By Robert Di Scipio, Aegis President & CEO

As we prepare for our annual customer conference here in Colorado this fall, the Aegis team is giving careful consideration to the topics our customers want to address in the conference’s collaborative sessions. While the annual conference helps us accelerate product development, recent attendees say that they learn from our staff and their industry peers how to maximize the return from their Discoverant configuration.

With the realization that continued feedback is critical to enhanced product development and usage and in response to the requests of 2007 conference attendees, we are pleased to announce the launch of an online forum for Discoverant users. The Discoverant Community of Practice is a forum dedicated to addressing industry issues that affect your business. Aegis stays on top of these issues by writing articles for trade publications, and attending, and also presenting at, many industry conferences and forums. We recently co-presented with Eli Lilly at the Annual Biological Production Forum in Munich, Germany, on the role of on-demand data access, aggregation and analysis in achieving process excellence.

You can read more (below) about the annual customer conference, the Community of Practice and our presentation with Eli Lilly in Munich. We look forward to seeing you at our customer conference on September 30, 2008.

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AEGIS INTELLIGENCE
Join New Discoverant Community of Practice

Our customers asked us for, and we have delivered, a forum in which to exchange ideas, questions and best practices around process development and manufacturing with other Discoverant users from around the world.

The Discoverant Community of Practice (CoP) is an online user portal specifically designed for information sharing among members of the Discoverant user community. Driven by the Discoverant user community, the CoP will provide collaborative forums, member directories and an embedded content management system.

The goals of the CoP include:

  • Provide a forum for Discoverant users to interact and exchange ideas and best practices online
  • Build a professional community through cross-company and cross-industry discussions and knowledge sharing
  • Encourage professional dialogue, debate and collaboration about the best ways to use Discoverant
  • Identify ways that Aegis can improve our products and services

You can access the CoP at www.discoverant.net. Discoverant users will be automatically invited into the Discoverant CoP portal. Look for an email this month from Justin Neway that will include your User Name and Password.

If you’re not currently a Discoverant user but would like to be considered for temporary access into the portal, please complete the registration form at www.discoverant.net.

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Register Today for Aegis User Advisory Event

Join Aegis for three days of professional and technical discussions, training and networking at the 2008 Aegis User Event: The Building Blocks of a Successful Quality by Design Initiative in Boulder, Colorado, September 30-October 2.

Highlights of the event include:

  • Keynote presentation by Stephen S. Little, author of The Milkshake Moment: Overcoming Stupid Systems, Pointless Policies and Muddled Management to Realize Real Growth, in which he shows readers how to identify and overcome the stifling behaviors built into their organizations and lead the way toward substantive change and real growth.
  • Customer delivered presentations, insights and case studies
  • Best practices for achieving Quality by Design (QbD) and Process Understanding discussed among industry leaders and peers
  • Sneak preview of the upcoming product updates to be launched in Discoverant 3.3
  • Drive insights into the design and development of Discoverant 4.0
  • Discoverant training for specialty applications
  • Best practices for implementing, administering and using Discoverant

For a complete agenda and to register online visit www.aegiscorp.com/2008CAP

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Discoverant 3.3

Aegis developers are working on the latest updates to Discoverant. Version 3.3 will be available Q4 2008. Look forward to these new features:

InVision
• Multi-Factor ANOVA will be added to allow users to analyze Factorial experiments.

• Non-Normal Data: The InVision Quality Monitor and Statistics modules will be updated to allow analysis of non-normal data.

• Alerts: InVision will automatically notify users if processes violate the Western Electric Rules.

• Automated Testing: Hierarchy Manager will be able to test returned data automatically against expected values.

• Query Pathways: Hierarchy Manager will have even greater control over the queries used to retrieve data in Analysis Groups.

Hierarchy Manager
• Automated Testing: Hierarchy Manager will be able to test returned data automatically against expected values.

• Query Pathways: Hierarchy Manager will have even greater control over the queries used to retrieve data in Analysis Groups.

PRIMR
• Dynamic Page Creation: Users will have more control over the creation of pages within a PRIMR book. Multiple copies of pages can be created and, pages can be omitted from or added to in-process books.

• Reconciler Page Assignment: Individual pages may be assigned to specific reconcilers, allowing targeted reconciler work lists.

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Aegis and Lilly Demonstrate QbD

At the June Biological Production Forum in Munich, Randall Tatlock, Eli Lilly & Company’s associate information consultant, joined Aegis’ Justin Neway to present a workshop on “Achieving Manufacturing Excellence Across the Global Manufacturing Network Using an On-demand Process Data Access and Analytics Platform.” The presentation highlighted competitive and regulatory drivers for change, benefits and technology aspects of on-demand data access and analytics, the new IT paradigm for global manufacturing networks, making the business case for a data access platform, and change management and user retooling.

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Aegis Continues Growth, Hires Business Development Leader

Aegis recently expanded it workforce to meet increased demands for its products and services due to new growth in business. Professionals from across all functional areas including engineering, applications, professional services, quality, administration, sales and marketing have been hired to meet the needs of current customers and the demands of new growth.

Among its recent hires, Aegis added Julian Gallow to lead its business development efforts. Gallow will utilize more than 20 years of experience in leading and growing companies in enterprise software, specialized hardware, finance and manufacturing and various military and national government bodies. He brings to Aegis a valuable combination of vertical, technical and business skills that will help the company expand.

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Aegis’ CEO Honored by Ernst & Young

Aegis President and CEO Robert Di Scipio was chosen as a finalist for the Ernst & Young Entrepreneur Of The Year 2008 Award in the Rocky Mountain Region. The annual awards program recognizes entrepreneurs who demonstrate extraordinary success in the areas of innovation, financial performance and personal commitment to their businesses and communities.

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DISCOVERANT @ WORK: Power User Tips
Analyzing Process and Raw Material Lot Changes Using Derived Parameters
By Brent Rognile

We’ve all been there. Our manufacturing process is producing consistent, acceptable products. Then, with no warning, failures and variability start occurring, leaving our team with the daunting task of understanding the root cause.

It’s at this point where we begin the critical task of building hypotheses about what caused the change. The cause may be an easily identifiable source, such as an equipment modification or, something much harder to diagnose, such as subtle changes in the manufacturing process or raw material lot changes.

Unfortunately, process and raw material lot variability are typically more difficult to test. But, by using the Derived Parameter functionality, Discoverant users are able to easily create parameters that indicate where raw material lot changes occurred in order to help diagnose the problem.

A string parameter in Discoverant can be either a Category or an Event parameter. Category parameters are the most common among our customers, e.g. Process Train, Equipment ID or Raw Material Lot ID, which can be used to make group comparisons in Discoverant. However, in the case of process or raw material lot changes, Event parameters, used in the Tri-Panel Event plots, can be plotted along with process outcomes to see if the events are coincident with changes in the those process outcomes.

Applying the Formula
Your formula must compare the current lot number to the previous lot number. If it is different from the previous one, set it equal to the current lot number, otherwise leave it blank.
This can be done in Invision by selecting the following menu option:

Parameter > New > Derived Discrete

The formula to use is:

if(“raw lot number” <> lag(“raw lot number”,1), “raw lot number”)

The value of the 2nd argument in the lag function specifies the row offset to reference. A value of “1” refers to the previous row whereas a value of “-1’ would refer to the following row. The formula above would always result in the first row having a value equal to the current raw lot number because there is no previous row. This could be modified to always have a blank for the first row as follows:

if(“raw lot number” <> lag(“raw lot number”,1) and lag(“raw lot number”,1) <> null, “raw lot number”)

Once the new parameter has been created, it has to be set as an event parameter by checking the “event” box in parameter properties. Now it can be used in the Event Tri-panel plot.

Helpful Guides
Derived Parameters: Math Functions
Derived Parameters: Hierarchy Manager


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In This Newsletter

INDUSTRY INSIGHT
Industry Collaboration Delivers Best Insight

AEGIS INTELLIGENCE
Join New Discoverant Community of Practice

Register Today for Aegis User Advisory Event

Discoverant 3.3

Aegis and Lilly Demonstrate QbD

Aegis Continues Growth, Hires Business Development Leader

Aegis’ CEO Honored by Ernst & Young

POWER USER TIPS
Analyzing Process and Raw Material Lot Changes Using Derived Parameters

Join Aegis

Heidelberg PAT Conference
October 28-30, 2008
Unversity of Heidelberg, Germany


Aegis’ Justin Neway will present “Achieving the Goals of QbD and PAT – Bridging the Gap between Process Development and Manufacturing” to the fourth annual International PAT Conference organized by the University of Heidelberg. The conference is intended to provide an update on how PAT can be applied in today's pharmaceutical development and manufacture.

WBF European Conference
November 10-12, 2008
Barcelona, Spain


Joe Rothman, Aegis’ vice president of professional services, will present “Leveraging Process Intelligence for Product Lifecycle,” addressing advantages gained by both IT and manufacturing – and ultimately their businesses’ bottom lines – through collaborative implementation of Manufacturing Intelligence software.

Manufacturing Buzz
Process Excellence: Five Critical Elements of Quality By Design
by Justin Neway in BioProcess International (May – register online for free to access full article)

Process Development and Manufacturing Need To Be One Team
PharmaManufacturing.com interview with Aegis’ Justin Neway (April)

No Time for Quality
PharmaTechnology’s Erik Greb blogs about Justin Neway’s presentation at Interphex2008, when he cited survey results about obstacles to QbD implementation. (March 27)
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©2008 Aegis Analytical Corporation