How Advanced Stability Optimization Accelerates Therapeutic Antibody and RNA Development
Stability is Key in Therapeutic Antibody and RNA Development
RNA-based therapeutics are emerging as the primary treatment modality for traditionally “un-druggable” targets. Since the approval of the first siRNA drug in 2018 to the expedited development of the COVID mRNA vaccine in 2020, the development of RNA therapies has been center stage.
RNA therapies vastly increase the treatment landscape by broadening therapeutic targets, however ab initio development presents notable challenges.
RNA is intrinsically unstable and often requires sequence modification(s) such as 5’ capping, 3’ polyadenylation, incorporation of non-canonical bases, and optimized buffer conditions to ensure metabolic stability, efficacy, and prolonged shelf-life. Additionally, the RNA should be engineered for in vivo degradation to regulate stability.
Many techniques are employed to study and characterize the stability of RNA for the optimization of sequences and solution conditions to ensure maximum stability during bioprocessing, as well as pre and post administration. These techniques include native PAGE, size-exclusion chromatography (SEC), NMR, and PCR. These are all useful but fall short of in situ, temporal stability monitoring (aggregation and degradation) on multiple samples in parallel.
A higher throughput analysis permits biopharmaceutical teams to expedite therapeutic antibody and RNA development processes, getting therapies to market faster.
Balancing Innovation with Stability in Therapeutic Antibody and RNA Development
Therapeutic antibodies have transformed the treatment landscape, offering targeted therapies for a wide range of diseases. However, large-scale production is a complex and resource-intensive process that requires meticulous pre-screening for stability and developability. Early-stage discovery screening for attributes such as aggregation and degradation propensity, thermal stability, and manufacturability is critical to identify candidates that will succeed during clinical trials.
The stability of antibodies is not only a matter of maintaining efficacy but also ensuring safety.
Aggregation, for example, can lead to immunogenic responses in patients, which can be detrimental. How can one accurately predict and monitor the stability of antibodies throughout the development process, minimize risks, and maximize therapeutic potential?
ARGEN: A Comprehensive Biologics Stability Characterization Platform
ARGEN is a static light scattering instrument that can significantly enhance and expedite the development of stable and efficacious biologics. ARGEN’s advanced capabilities permit in situ, real-time monitoring of solution stability, providing formulation scientists with real-time data to make the crucial decisions needed to optimize candidates. By assessing aggregation and degradation kinetics under modeled stress conditions, ARGEN enables the rapid identification of formulations that are more likely to succeed in clinical settings.
ARGEN provides insights into the stability and aggregation behavior of biologics under varied stress conditions. Its ability to perform rapid parallel analysis of multiple formulations simultaneously, significantly accelerates the R&D process. This not only shortens development timelines, but also reduces R&D costs, making ARGEN an invaluable instrument for biopharmaceutical companies aiming to bring innovative therapies to market faster with higher efficiency.
Moreover, ARGEN’s versatility and ease of use makes it an ideal solution for both bench top research and quality control in large-scale manufacturing environments. Its user-friendly interface and robust data analysis capabilities ensure that scientists can focus on interpreting results and making informed decisions, rather than getting bogged down by complex data analysis.
Call to Action for Formulation Scientists
For formulation scientists working on cutting-edge research involving therapeutic antibody and RNA development, integrating ARGEN into your workflow can provide a significant competitive advantage. By leveraging ARGEN’s real-time stability monitoring and stress modeling capabilities, you can optimize your formulations for both stability and efficacy, reducing the risk of late-stage failures and ensuring that your therapeutic candidates are ready for clinical success.
If you want to learn more about how ARGEN can support your research and development efforts, contact Yokogawa Fluence Analytics to discuss how this powerful instrument can streamline your R&D processes, enhance the stability of your therapeutic candidates, and ultimately help you bring better therapeutic solutions to patients, faster.
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