Contract manufacturing organizations (CMOs) are complex organizations by their very nature. Their work requires precision processes, compliance with a host of regional and international regulations, robust supply chains, and much more. It comes as absolutely no surprise that today’s CMOs rely on a LIMS to keep their operations running smoothly.Contract manufacturing organizations (CMOs) are complex organizations by their very nature. Their work requires precision processes, compliance with a host of regional and international regulations, robust supply chains, and much more.

It comes as absolutely no surprise that today’s CMOs rely on a LIMS to keep their operations running smoothly.

The value of this approach was recently validated by the COVID-19 pandemic which created an urgent need – not only to bring high-quality products to market with exceptional speed, but to produce them in global volumes.

mRNA and LIMS

LIMS platforms were (and continue to be) instrumental in helping CMOs achieve the herculean task of taking mRNA technology from a promising therapy, to vaccines approved for emergency use, to two products with formal FDA approval as of this writing. LIMS platforms were (and continue to be) instrumental in helping CMOs achieve the herculean task of taking mRNA technology from a promising therapy, to vaccines approved for emergency use, to two products with formal FDA approval as of this writing.

This process happened in record time, smashing the pharma industry’s previous achievement of developing a vaccine for Ebola, which took five years.

How did LIMS enable CMOs to respond to the pandemic so quickly? Two critical benefits made it possible:

1. Accelerated Laboratory Processing

A LIMS can help speed laboratory processing by in multiple ways. First, it enables lab managers to assign employees and resources based on competency, availability and overall workload. In LabVantage, this is accomplished using the Work Assignment and Planning (WAP) module, which allows the manager to assign incoming tests based on employees’ calendars, an instrument’s certification status, and availability.

Once assigned, testing steps can be streamlined with automated workflows. Instead of clicking here and there in a LIMS application, the LabVantage Workflow Manager steps the user through precise, wizard-like steps, providing the instructions and fields for data collection that are required to complete the task.

In addition, individual testing can be performed using LabVantage’s Laboratory Execution System (LES), which is similar to an Electronic Lab Notebook (ELN). LES has the additional advantage of ensuring that all steps conform to rigorous standard operating procedures (SOP).

When testing requires laboratory instruments, the LabVantage Scientific Data Management System (SDMS) can be used to automate data entry, ensuring that all captured data is stored, secured, and auditable. In addition to maintaining complete data integrity, this approach can even support intellectual property claims.

2. Optimization of Supplies

The pandemic sent shockwaves through the global supply chain, impacting pharma and practically every other industry on the planet. Modern LIMS systems played a critical role in alleviating supply challenges by utilizing strategies such as:

  • Strategically optimizing the testing cycle, skipping the testing of lots when the quality of previous lots significantly exceeded required levels.
  • Automatically reducing the required volume of testing when the quality of previous lots was reasonably high.
  • Tracking the quality of products for certain suppliers and manufacturers, enabling CMOs to pinpoint opportunities to skip or reduce product testing.
  • Maintaining a precise inventory of consumables such as reagents and standards, including remaining volumes and their locations. The system also tracks critical data such as approval, effective, and expiry dates.

The lesson of the recent pandemic is that a modern LIMS can benefit CMOs (and the world at large) by empowering the rapid, high-quality development of life-saving technologies — even under crisis conditions.

Achievement Today, Hope for Tomorrow

Although COVID-19 continues to linger and no one can predict when the next global health crisis may occur, the value of modern LIMS systems is clear. The lesson of the recent pandemic is that a modern LIMS can benefit CMOs (and the world at large) by empowering the rapid, high-quality development of life-saving technologies — even under crisis conditions.

To learn more about how your CMO can benefit from the advanced capabilities of a LabVantage LIMS, contact us today.