Produced in Partnership with RedShiftBioReviewed by Maria OsipovaOct 10 2024
Bioprocessing presents distinct challenges in product concentration monitoring, especially for contract development and manufacturing organizations (CDMOs). This article investigates the nature of these challenges and explores the transformative effect of the HALCON protein analyzer on CDMOs.
The Landscape of CDMO Challenges
CDMOs function in a dynamic environment, servicing an array of clients with different molecules, molecular formats, and production scales. The challenges linked to product concentration monitoring are particularly evident in the upstream manufacturing process, from inoculation to the transfer for purification downstream.
Traditionally, monitoring product concentration has demanded lengthy procedures, often leading to optimization delays and project timeline shifts. To save time and money, CDMOs require real-time insights and innovative solutions to meet these demands.
The Requirement for Rapid and Accurate Measurements
The critical moment for product concentration evaluation is the change from upstream to downstream processes. This necessitates precise and rapid quantitation to properly load columns throughout primary capture. Most CDMOs report development and manufacturing as the two key settings for such assessments.
Traditional methods involving centralized analytical labs lead to lengthy turnaround times in the development environment, where many clients and diverse molecules are handled. In manufacturing, delays in attaining results from quality control labs are suboptimal and result in higher costs.
The Ideal Solution: HALCON Protein Analyzer
Many CDMOs are now using RedShiftBio’s HALCON Protein Analyzer to solve these issues. This pivotal technology has a small footprint, stable calibration curve, fast sample assessment time, and compatibility with manual and automated sampling, providing adaptability for use in various settings.
A standout property of HALCON is its minimal sample preparation criteria. Dilutions within the usual upstream concentrations are not necessary, meaning that the analyzer increases efficiency in development and manufacturing settings.
Applications and Case Studies
The HALCON Protein Analyzer has several applications for CDMOs to investigate, including a generic method for process monitoring. Streamlining processes with a generic molecule for calibration can lower resource expenditures and increase consumable lifetimes.
The RedShiftBio website presents different case studies demonstrating HALCON’s effectiveness in tracking the production of bispecific antibodies and assessing filter fouling throughout the perfusion process.
Real-time assessments offer critical insights, making possible timely corrective actions and minimizing delays in experimental plans.
User-Friendly Implementation
Owing to its user-friendly nature, new users need just 30 minutes to learn how to use the HALCON system. The system reduces the learning curve during this time, allowing new users to understand the process quickly. The system’s minimal maintenance needs make it a viable choice for routine use.
Future Applications and Conclusions
RedShiftBio foresees wider applications for HALCON over a broad spectrum of stages in the bioprocess workflow, including research and development, as well as upstream and downstream uses. The 21 CFR package intended for early 2024 showcases RedShiftBio’s commitment to satisfying regulatory criteria.
The HALCON Protein Analyzer has proven transformative for CDMOs. It enables at-line monitoring of product concentration, offers real-time insights, and greatly reduces delays in process development and forward processing. In the constantly changing landscape of bioprocessing, pioneering solutions like HALCON can lead the way for higher productivity and higher efficiency.
About RedShiftBio
RedShiftBio is redefining the possibilities for analyzing protein structure and concentration.
RedShiftBio has developed a proprietary life sciences platform combining our Microfluidic Modulation Spectroscopy (MMS) and expertise in high-powered quantum cascade lasers that provide ultra-sensitive and ultra-precise measurements of molecular structure. These structural changes affect critical quality attributes governing the safety, efficacy, and stability of biomolecules and their raw materials. This combination of technologies is available to researchers in our fully automated Aurora and Apollo systems. It is backed by a global network of sales, applications, service, and support teams to address all market needs.
Alongside our commitment to further innovation in the formulations and development space, RedShiftBio also supports biopharmaceutical manufacturing with HaLCon, our bioprocess analytics platform, which is purpose-built to measure protein titers at the time of need.
Led by an experienced management team with a proven track record of success in both large instrumentation companies and commercializing disruptive technologies, RedShiftBio is here to support your research, development, and manufacturing goals. Our instruments can be found in most of the world's leading biopharmaceutical companies and CDMOs. We also run product demonstrations and process samples in the StructIR Lab, located in our Boxborough, MA headquarters, as well as at partner sites, including the Wood Centre in Oxford, UK, Spectralys/UCB in Brussels, Belgium, and at Sciex laboratories in Redwood Shores, CA.
RedShiftBio is backed by Waters Corporation, Illumina Ventures, Technology Venture Partners, and one undisclosed leading life science company.
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