The journey from lab to full-scale production
Imagine you’ve developed a groundbreaking bioprocess in the lab. It’s efficient, yields promising results, and has the potential to transform the industry. But how do you take it from the lab bench to large-scale production? That’s where scalability comes in. The formalized process occurs multiple times during a drug’s life cycle as it progresses from initial research in the lab to the pilot plant and eventually to commercial production. To be done right, the instrumentation will work the same way in the lab and in the process. This concerns aspects like measuring algorithms, modeling, cleaning protocols, sensor build-up and much more. Although scalability is a critical aspect of product development, it is sometimes overlooked during the initial stages. Being mindful of scalability from the outset results in the highest measurement accuracy and consistency, while accelerating new product market entry.
Common process scale up challenges
Technology transfer and associated lab-to-process scalability are significant challenges in biotherapeutic production because the manufacturing process not only needs to scale, so does the analytical and quality measurement approach. To add to the complexity, each stage of a product’s lifecycle — from research and development through clinical and commercial manufacturing — often takes place at different locations around the world.
Differences in equipment may impact the process, necessitating adjustments or redevelopment which cause delay and introduce risk. Changes in scale or location often introduce process variability. When a process is scaled up from the initial laboratory bioreactor to pilot and fully scaled, it is vital to keep all conditions unchanged. Any parameter values that are outside the specification risk product quality and could result in high costs and decreased yield. Many biomanufacturers prefer to standardize their sensor and analytical technology from lab to process to avoid measuring discrepancies when the process is upscaled, risking a decrease in process yield.
Why easy scalability matters
Scalability isn’t just a buzzword; it’s a strategic advantage. Whether you’re a large biopharma giant or nimble start-up, the ability to scale your processes effectively can make all the difference. Successful scalability involves a holistic approach that integrates process understanding, equipment scalability, model transferability — and above all, measurement reliability and consistency. By smoothly transitioning from small-scale experiments to pilot plants and eventually full-scale production, you can accelerate your time to market, reduce risk, and maximize yield.
Dive into why easy scalability matters and how Endress+Hauser’s scalable bioprocessing measurement portfolio can give you a competitive edge.
Use the same measurement technology - from lab to pilot and production
Endress+Hauser empowers manufacturers to design efficient, transferable processes for higher yields and better patient outcomes. Whether you’re in the lab or on the production floor, our inline analysis technology seamlessly adapts to different scales, from batch to continuous processes and various bioreactor types. Continuity of measurement is crucial, and our systems share common technology and materials, allowing easy protocol transfer from R&D to manufacturing. By adopting our scalable Raman systems and liquid analysis digital sensors, you can simplify equipment complexity and reduce measurement consistency risk. Explore our optimized bioprocessing devices for upstream and downstream applications, including spectrometers, sensors, transmitters, assemblies, optics, and calibration tools. Measure composition, pH, dissolved oxygen, conductivity, and more using the same devices in both lab and process environments. Download our eBook to explore our full portfolio of scalable Raman systems and cutting-edge liquid analysis digital sensors.
Discuss your scale up challenges with our Life Sciences experts
Endress+Hauser technology is designed to allow you to transfer your process the lab to manufacturing with ease using the same high-quality instrumentation and systems. Have questions? Our local Endress+Hauser Life Sciences process automation experts are here to support you.
