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There are many challenges to overcome as a new product moves from first development to production. There are a myriad of issues that can affect the outcome during scale-up production, including different lot sizes, different process conditions and changing parameters. Any one of these can trigger unexpected problems that negatively impact performance. Creative Biogene provides customers with comprehensive solutions and support at all stages to scale up all processes from lab to pilot scale to commercial production.
The goal of process scale-up is to ensure stable growth of cells in a relatively constant environment for product expression at progressively larger cell culture sizes. The key control parameters during process scale-up will fall into two types. One type is volume independent, such as temperature, DO and pH. The other type is influenced by volume and geometry, such as stirring speed and aeration flow. When scaling up processes with production equipment, mass balance, end product quality, and process sensitivity points need to be closely monitored and further optimized.
We offer small-scale manufacturing services to help our customers set up and optimize their manufacturing processes, assess product quality and purity, and produce sufficient material for preclinical and clinical trials.
We offer pilot-scale production batches that can be used as trial batches for commercial production, either for sampling purposes or as interim services for start-up or optimization to help our customers successfully scale their project production to market.
Creative Biogene utilizes our state-of-the-art facilities and production platform to provide high quality large-scale production services of biologics such as antibodies, proteins or vaccines to meet our customers' demands for large volumes of biologics.
Creative Biogene has an experienced process technology team that can help customers achieve effective process transfer and scale-up. Our scientists use the quality by design (QbD) approach for upstream process development in production, taking advantage of technologies and equipment such as design of experiments (DoE) and high-throughput parallel bioreactors to efficiently complete laboratory-scale R&D processes, to understand the relationship between product critical quality attributes (CAQs) and critical process parameters (CPPs) as early as possible, and to determine the Design Space in R&D processes. Once these small-scale R&D processes are completed, process scale-up is next required. Ideally, an efficient process scale-up can complete the transition from R&D scale to pilot/production scale in 2-4 months. Once your process is running at industrial scale, we need to rethink or redesign certain process steps or components. The data generated during the scale-up process is reported in detail so you can monitor the techno-economic feasibility of your process.
Fig. 1 Process for upscaling and production.
Creative Biogene's upscaling & production services help customers understand the ultimate potential of their products and avoid the obstacles that may be encountered during process scale-up and the best practices that need to be followed during the process. 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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