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IDBS Blog | 21st December 2023

How to leverage your MES data for process lifecycle insights with PIMS

By Ken Forman, Lead Product Manager, Manufacturing, IDBS

In a previous blog post, I outlined how the IDBS PIMS platform can work synergistically with your existing electronic batch record (EBR) system. This time we’ll continue the discussion of where PIMS fits within the ecosystem of manufacturing/supply chain software by reviewing how PIMS can help you fully leverage your MES (manufacturing execution system) data for process lifecycle insights and better business decisions.

If you are new to MES software, learn more here.

Get more insight and value out of your MES (manufacturing execution system) data with PIMS

First, many of the same examples I described in the previous blog also apply to MES (manufacturing execution system). Until relatively recently, electronic batch recording was directly associated with MES. Although MES functionality extends far beyond the elimination of paper batch records, many manufacturers who’ve implemented MES still struggle to access and organize critical quality and process data for regulatory reporting. 

As a reminder, these are some of the biggest gains reported by our customers who have implemented PIMS:

  1. Improved process monitoring: PIMS can query critical data stored in the MES/EBR, combine it with relevant data from other sources such as LIMS, historian and supply chain systems, and analyze it across batches to speed up continued process verification (CPV) reporting and automate process control.   
  2.  Faster investigations: MES are designed for execution flow management along with real-time quality control with alarms and business rules to identify any deviations. However, when a deviation occurs, the subsequent investigation to determine the root cause can be time-consuming and resource-intensive. Since PIMS can analyze MES (manufacturing execution system) data alongside other contextually relevant data, root cause analyses can be done much faster to minimize downtime. 
  3.  Smoother tech transfer: PIMS provides a single environment that offers collaboration capabilities with both suppliers and manufacturing partners, be they captive or external CMOs. Data can be instantly shared in a secure manner while restricting visibility on a need-to-know basis. This single source of truth both speeds up and reduces risk to the tech transfer process and its intended outcomes. 

What about the MES of the future?

Many manufacturers are frustrated with traditional MES (manufacturing execution system). Many MES systems were developed for other (non-BioPharma) industries and weren’t designed for the reality of biomanufacturing such as repeated manual tasks in a heavily regulated environment.

When planning to deploy an MES, plan for the fact that many factors, including inflexible architecture, lack of preconfigured workflows, lack of standardized connectivity to common instruments and the heavy burden of validation all contribute to expensive and lengthy implementations. And while the majority of biomanufacturing is for monoclonal antibodies, which are generally well suited to a platform production process (i.e., standardized manufacturing steps), the picture changes completely as we move to advanced therapies and precision medicine. Batches of cell and gene therapies (CGT) can be as small and individualized as a single patient, which is a far cry from traditional manufacturing.

To start addressing the gap between current MES solutions and the collective needs of the BioPharma industry, BioPhorum, an industry group, has published an “MES of the Future” manifesto with input from both biomanufacturers and MES vendors. From this joint publication, it’s clear that the MES of the future needs to be:

  • Modular and flexible
  • Easily scalable with comprehensive libraries of operations
  • Fully integrated both vertically and horizontally
  • Intuitive, easy to use and configure 

Another way of viewing the future role of MES, in the broader business context of manufacturing operations, is BioPhorum’s Digital Plant Maturity Model (DPMM) which describes five levels of maturity from simple paper-based plants to the fully automated and integrated “adaptive plant” of the future. While no one has reached level five yet and most companies are around levels one or two, this is a useful framework for digital transformation that highlights the interdependencies between systems and the fundamental need for reliable, accessible and integrated data. 

Sound familiar? It should; reliable, accessible, and integrated manufacturing data is exactly what PIMS provides while adhering to the F.A.I.R. principles.

This leads us full circle to how IDBS customers are leveraging PIMS in their digital plant architectures. Many start-ups and companies who are early on their digital journey (typically in level one or level two of the DPMM) find that, while an MES is indeed on their digital roadmap, it will likely be years before budget or resources will be available to implement such a system. At the very least, they are often looking at one to two-year implementation timelines. 

These companies find that the ability to quickly deploy and validate PIMS with minimal IT resources provides the perfect bridge for quickly adding a GxP solution for collating, monitoring, analyzing and reporting on data. For companies already at DPMM level three, with an MES system up and running, PIMS provides a simple integration interface to pull critical quality and process data to be analyzed alongside sample, automation and raw material data. As your team lays out a roadmap for your digital future, we’d love to talk with you about where PIMS can fit in and enhance your internal data intelligence. 

 

If you liked this blog post, read more from Ken Forman.

How to get more insight and value out of your electronic batch record data with PIMS

Meeting tech transfer challenges when manufacturing new biopharmaceuticals

Process digitalization for tech transfer in pharma helps reduce risks in data availability and persistence

 

 

About the author

Ken Forman, Director of Product Strategy, IDBSKen has spent over 30 years in product, project and IT operations leadership focused in the software and life science industries. Prior to joining IDBS, where he focuses on software to manage BioPharma manufacturing process data, Ken served as Director, Project Management at BIOVIA.

Previously, he was Director of Commercial Operations at Fischer Imaging and Director of IT at Allos Therapeutics and Genomics. 

Ken holds a BSc in Computer Science from Cal Poly and an MBA from the University of Colorado, Denver. 

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