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Pilot scale-up is the necessary transition from small-scale experiments to industrial production, and is also an effective measure to reduce the risk of industrialization. Creative Biogene provides high quality pilot scale production services to customers worldwide. We offer pilot-scale production batches as trial batches for your commercial production. These trial batches can be used for sampling purposes or as interim services for start-up or optimization to ensure that your project's production can be successfully scaled to market.
Pilot scale-up is to study the feasible solution for industrialization based on small pilot experiments. It further studies the changing laws of the reaction conditions and processes of each production step in a certain scale of the device, and solves the problems that cannot be solved or discovered in the laboratory, and provides the design basis for industrial production. While the nature of production does not change depending on the scale of amplification, the optimal reaction process conditions for each production step may change depending on external conditions such as experimental scale and equipment. Therefore, pilot scale-up is an important transition stage from rapid, high level to industrial production.
The task of pilot scale-up is to develop a scalable process for producing a biotherapeutic product at a larger scale that matches the product required for clinical or commercial use. The goal of pilot scale up is to produce a product that is consistent in quality, purity, and potency with the product that was initially developed in the laboratory.
Pilot scale-up involves several key tasks, including:
The initial laboratory process is optimized to maximize production and yield.
The process is scaled up by replicating the optimized laboratory process in small-scale bioreactors, and then gradually increasing the volume of the bioreactor.
The process is then transferred to a manufacturing facility where it is further scaled up, according to Good Manufacturing Practices (GMP) standards, for manufacturing clinical supplies.
The product is subjected to rigorous quality control measures to ensure safety, efficacy, purity, and potency.
The pilot scale-up process follows the regulatory guidelines implemented by the FDA.
Creative Biogene provides excellent pilot scale up production services to our customers in a competitive manner.
Creative Biogene is committed to providing rapid, high-quality pilot scale-up production services to our global customers using our leading pilot facilities and scale-up processes. Our customized services can be tailored to meet any of your research or development demands. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
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