As we celebrate the launch of our 2nd product, the Proteometer-UFT Kit, we sat down with our Director of Product Management, Eric Bowen, to discuss what need this product fills and its detailed development process.
Read what he had to say below and reach out to info@novilytic.com if you have any additional questions for Eric about the Proteometer-UFT Kit.
Q: What does UFT stand for?
A: The UFT in Proteometer-UFT stands for “Ultra-Fast Titer.” I should also mention that the product name Proteometer stands for “Proteoform Meter.”
Similar to how a parking meter provides a warning of the time remaining for a particular space, a Proteometer acts as an early warning system for mAb structural changes.
All our current and upcoming Proteometer Kits address pain points at various stages of the drug development process. The Proteometer-UFT Kit is the result of our customers informing us that titer measurement is one of the most important, frequently performed, and time-consuming steps in their medicine-making processes.
Q: Who is the product for?
A: It is for pharmaceutical scientists, engineers, and production managers who need very fast at-line titer measurement of monoclonal antibodies. Unlike common LC, CE, and MS-based assays, the Proteometer-UFT provides answers in less than 90 seconds from a crude culture filtrate sample.
Q: What is it from a scientific standpoint?
A: The Proteometer-UFT is a homogeneous immunological assay wherein a molecular recognition agent binds to antibodies, and the host cells and antibodies are eluted together. The contribution of host cell proteins is accounted for by subtraction of a clarified fermentation broth blank. It provides a very fast analytical test of human or humanized mAb titer at 90 seconds per sample needed to complete a cycle. Sample consumption is low, generally ≤ 20 µL per test.
Q: Why is it unique and what problem does it solve?
A: The Proteometer-UFT is the only product available on the market that can rapidly perform serial assays of mAb titer in less than two minutes, with no sample preparation, or Protein-A purification in the dual pump configuration (single pump requires minimal sample prep, no Protein A).
In addition to time savings, it is potentially more accurate since there is no sample preparation involved (single pump requires minimal sample prep). Limiting preparation is important because every step during sample preparation may introduce small inaccuracies, which can add up. For example, some Protein A purification processes have many steps, and every step has potential to introduce a small amount of inaccuracy to the titer measurement. Our customers routinely allow for up to 10% inaccuracy with Protein A purification. We achieve an average of <10% with the Proteometer, meeting industry standards.
The Proteometer-UFT can test up to 960 samples per day, providing rapid, easy-to-use mAb titer analysis during clone screening and selection. This potentially saves customers hours, and millions of dollars, by condensing mAb titer testing into a single day.
Customers no longer need to wait for costly and time-consuming Protein A purification or lengthy sample preparation to get the answers they seek. The Proteometer-UFT will provide customers with the rapid titer results (some may say ultra-fast 😊) that they need to make sound and timely data-dependent decision-making.
Q: How is it used? A: It can be used during clone screening, clone selection, and growth optimization to rapidly determine titer content, as well as a precursor to additional quality tests like charge variants analysis, etc. Further, we have customers who see this rapid titer measurement as a great opportunity for downstream applications as well as “near-real-time” monitoring of continuous processes.
View our how-to video here: Video: Proteometer-UFT Kit Instructions for Use
Q: Who should consider purchasing a kit?
A: It is for anyone who requires upstream or downstream rapid titer results in minutes, without having to do purification steps.
Q: Has the technology been proven? If so, how?
A: The technology has been proven for mAb titer determination through extensive testing, using both NIST mAb 8671 and biosimilars. Reproducibility and Linearity data for the mAbs tested may be found below.
--
We thank Eric for taking the time to walk us through the new Proteometer-UFT Kit. Those interested in learning more about this kit, or any of our additional products are encouraged to visit: Novilytic Products | Proteometer Kits.
Figure 1. Dual Pump Data
Figure 2. Single Pump Data
###
Comments