Don't Spend All Day Combing Through Data; IOPS has a Better Way

ALBANY, N.Y. - July 1, 2013 - PRLog -- Tired of spending half your life painstakingly copying and pasting data from one spreadsheet to another only to have to do it again two months later when you can’t remember which spreadsheet you updated last?

Regeneron in Rensselaer has the solution: a new centralized site wide data management system that removes a lot of the upfront work of collecting, organizing and displaying data so IOPS employees can focus on what they do best: examine chemical reactions during research and development as well as production of commercial drugs.

Manufacturing requires precision and even on days when everything is going smoothly the process is evaluated every step of the way. That means tracking everything from pH to connectivity, to what time a chemical is added to how long it’s been mixing and how long it’s been filtering, minute pieces of data that multiply exponentially with every production run.

Historically, data generated during manufacturing at Regeneron’s IOPS facility has been stored in multiple locations, both electronically and in traditional paper files including the laboratory information management system (LIMS), the QUMAS electronic document management system, the operational performance management (OPM) system and Manufacturing Records (MRs). With the introduction of a centralized data management system, all of the data can now be accessed through one portal. It’s called the Regeneron Application for Data Aggregation and Reporting, also known as RADAR.

Launched at the end of last year, “RADAR is a one-stop shop for all of the data related to the manufacture of EYLEA® and ZALTRAP®,” according to Matt Smith, who is part of the Process Sciences team that manages the centralized data management system. “It pulls operations data from each server into one convenient location.”

“The earlier repositories for data were great in terms of storing data, but they weren’t designed to display the data with charts that aid analysis.” said Abdel Zamamiri, who is also part of the RADAR team. “RADAR is designed for data analysis. It can be used to generate routine regulatory reports, even shift reports, or for problem solving on the floor during production.”

In order to ensure consistency and quality, current data is constantly being compared to historical data during the manufacturing process, according Virginia Muñiz, a biochemist who is part of IOPS’ Manufacturing Technology Services. She provides technical support for manufacturing at IOPS. “This program does it for you,” she said. And it does it in minutes, even seconds, which is considerably faster than it used to be.

“Last year it took hundreds of hours, and people had to be pulled off their primary function to pull data for two annual regulatory reports,” according to Michael Ayers, a chemical engineer who is part of the Process Sciences department. “We had to go into multiple electronic systems and painstakingly pull out data sometimes one piece of information at a time. And that was just with one molecule, VEGF, which is used in the production of Eylea and Zaltrap. This year we were able to generate the reports much more quickly and no one was pulled off their primary function.”

"Another advantage of RADAR is certainty on data reliability," Mike said. "It’s entered into the system one time and verified so you know it’s up to date. You don’t have to go through your desktop spreadsheets again to make sure the data has been updated."

More than 60 IOPS employees have already been trained to use IOPS RADAR. Stay tuned for a new schedule of training dates or contact Joe Raggi at (518) 824-4423.