Process Development and Analytical Testing

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  • 1PLATFORM4
    Process Development
    and Analytical Testing

Beyond LIMS

Our 1PLATFORM4® Process Development and Analytical Testing Software Suite is an integrated IT solution designed on a adaptable platform.

Process Development

  • Manage inventory stock levels and pinpoint specific locations of materials with an integrated material repository
  • Streamline management of upstream and purification processes
  • Ensure reliable flow of raw materials and work-in-process inventory
  • Facilitate the selection of lots for preclinical testing
  • Enhance process visibility and efficiency

Analytical Testing

  • Improve efficiency with automated test request processing
  • Ensure timely stability testing of materials and protocol execution
  • Control and monitor materials submitted for testing in real time
  • Enhance visibility, data analysis and information transfer
  • Generate and approve Certificates of Analysis (CofA)

View Our Video

See how our 1PLATFORM4 Software Suite can help you manage stability studies.

Streamline your operations with BioIT Solutions’ 1PLATFORM4 Process Development and Analytical Testing Software Suite. We combine our IT expertise gained from decades of experience in the biopharmaceutical industry with our flexible 1PLATFORM4 Software Suite to provide solutions that are rapidly deployed and customized in a cost-effective manner.

Material and Inventory Management
Production Workflow Management
Analytical Testing Task Management
Security, Access and Compliance

1PLATFORM4 in Action

View a few examples of 1PLATFORM4 Process Development and Analytical Testing

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Customer Spotlight

Read our customer spotlight to learn how the 1Platform4 Software Suite for Process Development and Analytical Testing improved operational efficiency for one of our clients, a leading clinical-stage biotechnology company.

REGENEXBIO

“The 1Platform4 Software Suite is now a vital part of REGENXBIO’s operations. It has transformed the way the company works by eliminating clerical work and freeing up more time for science. We now have an IT system that acts as the backbone for development operations and is used by process development, QC, and analytical development.”

Demonstration - 1Platform4® Manufacturing

Bob Beliveau demonstrates 1Platform4® Manufacturing.  We show how a lot trace tree can be assembled by defining a Bill of Materials (BOM).  The lot trace tree consolidates information from various domains; Release/Stability results from the integrated LIMS, Batch Record Data (EBR/MES), Documents from an eDMS, Deviations/OOS from a CAPA system, etc.  This powerful view provides clarity around manufacturing data and promotes product/process understanding.

Blog Post

Getting your Automation Projects off the Ground – Just do it!

By Bob Beliveau. At BioIT Solutions, one of our core principles is to learn from experience. Rather than initially building a large, comprehensive system, we counsel our customers to carve out a modest set of capabilities and get the system operational quickly. Once the system is in production, we often find that our pre-implementation concepts […]

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