Innovative Practices Winner: Chromatography Data Management

By Allison Proffitt 

May 21, 2024 | Innovative Practices Winner—In their pursuit of differentiated therapeutic antibodies, Genmab found chromatography data a particularly unwieldy piece of the pipeline. “Chromatography is very important for us to drive our pipeline,” said Rik Rademaker, Director of Cell and Molecular Science at Genmab at the Bio-IT World Conference & Expo earlier this spring. Capillary electrophoresis SDS (CE-SDS), size-exclusion chromatography (SEC), cation exchange chromatography (CIEX), and hydrophobic interaction chromatography (HIC), among others, are integral for assessing the quality and developability of biotherapeutics such as monoclonal or multi-specific antibodies. And capturing the increasing volume of chromatography data holds great potential for future AI and machine learning.  

Genmab partnered with Genedata to address these challenges to capture the chromatography data. Their effort earned them a 2025 Innovative Practices Awards for their joint development of Chromatics, a new Genedata product developed to meet the needs of chromatography data.  

“Data from chromatography workflows are growing exponentially, making it increasingly onerous for biopharma… groups using different instrumentation to capture and process data, collaborate, assess results, and ensure consistent and reliable outcomes,” the Genedata team wrote in their Innovative Practices Award entry nominating Genmab and the joint work. “The results, in part, are error-prone processes, poor scalability, incomparable data, and resources in people, time, and money ill-spent.” 

Genedata wrote: “We recognized that scientists need a generic and open platform capable of bulk processing from different instruments that eliminates manual data adjustments.”  

Genmab had already onboarded the Genedata Biologics and Genedata Screener tools to help with data warehousing and data analysis of much of their pipeline, so the two groups worked together to develop Genedata Chromatics with the goal of creating a digitalized and unified platform for all chromatography analysis from metadata import to result calculation and making those consistent and reliable data available for AI/ML algorithms. 

Some of the key challenges Genmab hoped to address, Rademaker said, included being able to make batch adjustments, responding to different instruments performing similar processes but with different vendor metrics, managing mismatches between data in the ELN and the SDMS, and more.  

To address these issues, Genedata and Genmab collaborated on the development of a single generic solution that can integrate time/response data (e.g., chromatography and electrophoresis data) from various instruments (including Waters, ThermoFisher, Perkin Elmer, Agilent, ÄKTA) and process them using template-based workflows. 

“Once you’ve established a template, the next step you’re going to do is a repeated measurement.  You’re going to click on the template, load your data to the template, and everything is done automatically,” Rademaker explained. 

But Genedata is quick to point out that templates are not required. “Templates can be too rigid for more exploratory work, and additional data analysis freedom is required,” they write in the entry. “Chromatics does not enforce this, giving scientists ample flexibility.” 

While Chromatics became commercially available in April, Rademaker highlighted several customizations underway including vendor/device agnostic RNA quality assessment, quality assessment of Genmab’s DuoBody chromatograms, and deconvolution of mixtures. 

Time Saved, Money Saved 

The automated pipeline saves both time and money, Genmab reported. “We reduce the workflow from four to eight hours a week to less than half an hour with this automated analysis pipeline,” Rademaker said. “This is a very significant time reduction; this also means we can do more… with the same amount of people. We can actually create more datasets that we’re going to use.”  

Genedata estimated an annual cost savings of approximately $380,000 to $945,000 when automation is applied to the work of research scientists conducting chromatography.  

Harmonized workflows thanks to Chromatics will also result in improved business continuity, Rademaker said, thanks to vendor-agnostic workflows, faster onboarding of new hardware, and consistent, FAIR reporting to the data warehouse.  

“There’s, of course, harmonization. We removed biases. We get higher quality datasets,” Rademaker said.