Despite Antibody-based therapeutics being well established in the biopharmaceutical field, development and production of these drug products is not without challenges. Powerful analytical capabilities play a role in all stages from early development to large-scale production. ZipChip combines high resolution protein separations with the sensitivity and specificity of mass spectrometry for detailed characterization of mAb therapeutics at any stage. Here’s how ZipChip can be an asset to biotherapeutic development and production in your lab.
Charge Variant Analysis
Ever run a charge variant separation and want to know more about the peaks you’re seeing without having to do a lot of other long and tedious experiments? Us too. That’s why we developed our ZipChip charge variant assay. Our assay performs a high-resolution charge variant separation that directly interfaces the separation with high-resolution, accurate, mass spectrometry detection. This means in addition to a charge heterogeneity profile, you’ll obtain glycoform and accurate mass identifications of each variant in the profile. Complex glycosylation profile? No problem. Troublesome acidic species? ZipChip can ID those for you, including deamidations. To see the ZipChip charge variant assay in action check out these publications from NIBRT:
Comparative Elucidation of Cetuximab Heterogeneity on the Intact Protein Level
At-line Drug Product Characterization
Are you working closer to process development and the manufacturing floor? Keeping tabs on your bioreactors is a must, but looking at the drug product directly can provide additional insights into the health and productivity of the bioreactor. Because many ZipChip assays are tolerant of matrix components, mAb drug product can be analyzed directly from culture media with minimal sample processing. An example of this was performed by researchers at Biogen Inc. After sampling directly from the cell culture supernatant, the drug molecule was reduced and both light and heavy chains of the antibody were separated via ZipChip. In one quick method they measured both glycosylation profile and protein titer. The extent of glycosylation was assessed from the heavy chain and protein titer was determined from the light chain using heavy isotope controls. Both pieces of information were obtained using one quick method in agreement with established LC-MS and ProA titer methods. By monitoring the drug product throughout production, they were able to track the presence and relative abundance of key glycoform critical quality attributes, which can help detect bioreactor faults earlier. Read about Biogen’s method for using ZipChip to monitor key quality attributes during monoclonal antibody production here.
Don’t feel like reducing your mAb? Check out our intact mass assay. This is the simplest and most universal ZipChip assay. With a simple dilution, this high throughput assay will provide a mass spectrum for your mAb mass and major glycoforms in less than 2 minutes – it couldn’t be easier! Read our application note High-Throughput Intact Mass Analysis of mAb Based Therapeutics here.
So, what are the benefits ZipChip can bring to your development and production teams?
- Get the best of both worlds. Harness the power of both high-resolution separations and mass spectrometry to learn more in a single assay.
- In-depth characterization of your mAb. Detect and monitor a wide variety of critical quality attributes like glycosylation, production related post translational modifications, and degradation markers.
- Direct monitoring of the drug product. By sampling at-line over multiple timepoints, obtain a clear picture of how your drug product is changing over time.
- It’s simple. ZipChip methods are easy to implement. Pre-mixed reagent kits and method settings are available that eliminate the need for time-consuming method development.
By, Erin Redman