Biologics stability testing in pharmaceutical R&D typically requires weeks of waiting between processes. Formulation scientists must develop, assess, and then wait to discover if a formulation remains stable under stress. These delays can hinder innovation, waste valuable resources, and increase product failure risk further down the pipeline.
Image Credit: Yokogawa Fluence Analytics
R&D teams should be able to evaluate formulation stability in situ and in real-time without waiting.
Real-time insights for proactive innovation
Modern advances in biologics stability testing enable researchers to simulate stress conditions like temperature alterations and stirring and observe how a formulation responds instantly.
This opens new possibilities for pharmaceutical R&D by:
- Providing immediate feedback on formulation performance in real-time rather than hours, days, or weeks later
- Analyzing multiple formulations concurrently, decreasing the number of iterations
- Predicting aggregation and degradation patterns promptly, discovering issues as soon as they occur
This real-time approach gives formulation scientists the equipment to iterate quicker and more efficiently, ensuring the most favorable formulations proceed.
Smart solutions for R&D managers and innovators
The advantages of real-time insights affect R&D managers, directors, and innovation leaders overseeing the entire pipeline. Delays in biologics stability testing increase costs, risks, and lost market opportunities.
With real-time monitoring instruments, R&D teams can:
- Model real-world manufacturing stressors to prevent scale-up disruptions
- Improve development timelines by removing bottlenecks
- Decrease failed batch risk by acknowledging instability prematurely in the process
This allows innovation experts to experiment more optimistically. Biopharma teams can confidently pursue innovative ideas and formulations, knowing they can identify possible issues early on.
Smaller samples, bigger impact
Limited sample availability is a widespread issue during early-stage biotherapeutic R&D. Many real-time monitoring instruments now operate with microliter volumes, enabling teams to test more variables using fewer resources. This efficiency lowers costs and helps researchers move quicker without losing precision.
The future of biologics stability testing in pharma
The pharmaceutical industry is moving toward faster, more reliable workflows as real-time technologies become more available. By replacing long stability studies with immediate feedback, biopharmaceutical companies can lower risks, accelerate time-to-market, and better use resources.
This evolution transforms how R&D teams work, allowing them to move from reactive problem-solving to proactive innovation and creating better products delivered faster.
About Yokogawa Fluence Analytics
Yokogawa Fluence Analytics, which was named as a Top 50 global advanced manufacturing startup by CB Insights, provides patented process analytics and control solutions to polymer and biopharmaceutical customers worldwide. Yokogawa Electric Corporation acquired Fluence Analytics in January 2023.
Yokogawa Fluence Analytics is a global leader in real-time polymer reaction monitoring and control, and its industry-leading ACOMP product is the only commercially available smart manufacturing system that continuously monitors and measures polymerization reactions.
The company’s biopharmaceutical product line includes a high-throughput static light scattering instrument called ARGEN. ARGEN can independently measure the stability of biopolymers under thermal, chemical, and mechanical (physical) stress, while also performing shelf-life stability studies at low temperatures.
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