Optimizing bioprocessing in CDMOs: The role of HALCON protein analyzer in enhancing product concentration monitoring

Bioprocessing poses unique challenges in product concentration monitoring, particularly in relation to Contract Development and Manufacturing Organizations (CDMOs). This article explores the nuances of these challenges and discusses the transformative impact of the HALCON protein analyzer in the context of CDMOs.

The landscape of CDMO challenges

CDMOs operate in a dynamic environment, catering to a wide range of clients with varying molecules, molecular formats, and production scales. The challenges associated with product concentration monitoring are especially prominent in the upstream manufacturing process, from inoculation to the transfer for downstream purification.

Conventionally, monitoring product concentration requires time-consuming processes, frequently resulting in optimization delays and shifts in project timelines. To save time and money, CDMOs require real-time insights and innovative solutions to tackle these challenges.

The requirement for rapid and accurate measurements

The crucial moment for product concentration assessment is the transition from upstream to downstream processes. This demands accurate and fast quantitation to ensure columns are adequately loaded during primary capture. Most CDMOs identify development and manufacturing as the two key environments for such measurements.

Conventional approaches involving centralized analytical labs cause long turnaround times in the development environment, where multiple customers and diverse molecules are managed. In manufacturing, delays in obtaining results from quality control labs are suboptimal and lead to increased costs.

The ideal solution: HALCON protein analyzer

The HALCON Protein Analyzer from RedShiftBio is being adopted by many CDMOs to address these problems. This pioneering technology features a small footprint, stable calibration curve, rapid sample measurement time, and compatibility with both manual and automated sampling, providing adaptability for use in diverse environments.

A standout feature of HALCON is its minimal sample preparation requirements. Dilutions within typical upstream concentrations are unnecessary, meaning the analyzer improves efficiency in both development and manufacturing environments.

Applications and case studies

The HALCON Protein Analyzer has multiple applications for CDMOs to explore, such as a generic approach for process monitoring. The application of a generic molecule for calibration streamlines processes helps to reduce resource expenditures and maximizes consumable lifetimes.

Various case studies are presented on the RedShiftBio website, showcasing the efficacy of HALCON in monitoring the production of bispecific antibodies and evaluating filter fouling during a perfusion process.

Real-time measurements provide valuable insights, allowing for timely corrective actions and reducing delays in experimental plans.

User-friendly implementation

Due to its user-friendly nature, the HALCON system only requires a training period of approximately 30 minutes, during which the system minimizes the learning curve, allowing new users to understand the process quickly. The minimal maintenance requirements of the system also make it a practical choice for routine use.

Future applications and conclusions

RedShiftBio envisions broader applications of HALCON across a wide range of stages in the bioprocess workflow, including research and development, and upstream and downstream uses. The 21 CFR package planned for early 2024 indicates RedShiftBio’s commitment to meeting regulatory requirements.

The HALCON Protein Analyzer has proved transformative for CDMOs, facilitating at-line monitoring of product concentration, providing real-time insights, and significantly reducing delays in process development and forward processing. In the continuously evolving landscape of bioprocessing, pioneering solutions such as HALCON can pave the way for improved productivity and efficiency.

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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 and 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, purpose-built to measure protein titer at 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 the majority of the leading biopharmaceutical companies and CDMOs in the world.  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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Last updated: Feb 15, 2024 at 9:02 AM


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