Yuhwa's Biosimilars Analysis is a Slam-dunk with MFI + Bot1
"As a biosimilar company, we investigate whether our products are similar to reference material, and use the MFI to perform comparability and stability. We must test samples from a variety of sources... for all these samples, we chose the automated MFI with Bot1 because a manual-only system just wouldn't have enough throughput."
- Yuhwa Lee, Research Engineer, Samsung Bioepis
More than one hat for small biosimilars team
Samsung Bioepis is a division of Samsung that creates biopharmaceutical products. In this brand new venture, a core group of scientists is using cutting-edge technology, like MFI, to characterize many of its candidates as quickly as possible.
This division is pretty small yet, so the biosimilars group is hands-on at every stage of development, including quality control (QC).
The problem with non-trenders
The biosimilars group investigates whether or not their products are similar to reference material as far as comparability and stability go. So that means they have to do both structural analysis and physical and chemical analysis using UPLC, mass spectrometry and MFI on an almost daily basis. A whole host of samples need to be analyzed from different sources like cell lines, process development and purification samples. Using Hach's HIAC light obscuration system as a first pass gives them a view of sample trends. But trends alone didn't quite cut it when it comes to understanding particle changes in products with out-of-trend samples. They needed to classify particle types too.
Catching the particle culprits
The group used MFI to evaluate stability on any tricky, out-of-trend samples they ran in to. But because they need to look at samples across all their processes, that ups the number to analyze. So they added a Bot1. The MFI + Bot1 combo lets the biosimilars group do comparability, stability and classify particle types in every sample—the most important part as far as they're concerned. They now screen many samples types a day at a throughput no manual analyzer could ever kick out. And Yuhwa's colleagues also use the iCE system to analyze samples for charge-based heterogeneity.
Ramped-up particle classification
The biosimilars group at Samsung Bioepis will be kicking in to high gear soon and running even more samples for their drug product materials. The MFI + Bot1 not only lets them classify particles types, but also lets them hit their growing daily throughput needs too. Yuhwa expects the system to be in constant use soon between both the biosimilars and drug product groups.