HALCON: An automated, user-friendly instrument for real-time antibody concentration measurement and process development

HALCON is an automated instrument designed for real-time measurements of antibody or IgG protein concentration.

Designed to be a purpose-built solution, HALCON targets process development scientists focusing on simplicity and accessibility, sidestepping the need for extensive chromatography expertise.

Notably, it features a wide dynamic range spanning from 0.1 to 10 grams per liter, providing an alternative avenue to conventional techniques such as High-Performance Liquid Chromatography (HPLC).

HALCON's operational procedure has been optimized for maximum efficiency. The process begins with taking a sample out of the bioreactor. Next, a cell-free sample is made using methods like filtering or spinning. Following the injection of the sample into HALCON, the device instrument takes charge of critical tasks such as column preparation, sample loading, protein A column washing, elution of antibodies, and quantification.

The automation of these processes guarantees the rapid generation of a concentration of one gram per liter in just five minutes, eliminating the need for manual involvement.

One of the best things about HALCON is how easy it is to use. It is designed to be an accessible tool for process development scientists with varying levels of expertise in chromatography. Its minimal training demands enhance accessibility for teams with diverse skill levels, rendering it an inclusive solution. Furthermore, HALCON offers a high level of agreement with HPLC results.

This alignment is credited to the shared liquid chromatography technology between the two instruments, with HALCON emerging as the more accessible and purpose-built iteration specifically designed for bioprocessing environments.

The bioprocessing environment presents difficulties regarding instrumentation constraints for measuring titer. Current tools often prove inadequate for protein titer measurements, as they face limitations, particularly in terms of time-consuming sample preparation, inaccuracies, and limited dynamic range.

Multifunctional instruments not only increase training burdens but also escalate expenses associated with reagents. The constraints of retrospective analysis are highlighted, underscoring the urgent need for real-time data to facilitate prompt corrective actions and align with initiatives like Process Analytical Technology (PAT).

HALCON's workflow is centered around two consumables: an analysis module and a reagent pack. The ease of inserting and turning these tools into place eliminates the requirement for manual reagent preparation. This streamlined workflow not only minimizes downtime but also reduces the risk of failures associated with reagent-related issues, effectively addressing a common challenge in HPLC.

The process of running HALCON is delineated into four straightforward steps. Users begin by inputting the sample identifier on the instrument's touch screen, followed by selecting the calibration curve for quantification. Next, they inject the sample directly into HALCON and initiate the run. Subsequent automation includes preparation, loading, washing, elution, and quantification, all of which deliver results within a brief five-minute window.

HHALCON demonstrates versatility across different scenarios, providing support for autosamplers and online sampling tools to meet the needs of users requiring automated and real-time measurements.

The advantages and opportunities of online or at-line antibody titer testing with HALCON are highlighted in the resources available on the RedShiftBio website. These include the convenience of routine monitoring, which facilitates the generation of Design of Experiments (D.O.E.) and provides critical insights for process control.

The downloadable brochure highlights early decision-making, time savings in process development, and the ability to optimize processes. It also includes a summary of HALCON features and benefits, along with data points from a multi-day run to observe the correlation of results between HALCON and HPLC.

 

HaLCon: Real-Time Protein Titer Measurement for Bioprocessing

Video Credit: RedShift BioAnalytics, Inc.

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