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Each step of upstream development affects the quality, purity and quantity of the biologics produced. Creative Biogene's experienced upstream process development team identifies and optimizes upstream parameters with a variety of innovative technologies. These parameters are critical to achieving high quality, cost-effective biomanufacturing processes. We offer upstream process development services to ensure that you can scale up and meet GMP production requirements.
Process development and optimization at USP includes multiple components: cell line development and engineering, cell clone selection, media and feed development, bioprocess development, and scale-up production. In addition, reactor design, cell harvesting, process control, and corresponding analysis are also part of our optimization process. These areas are individually optimized to focus on consistent generation of high product titers, high productivity and defined quality. Our development team is dedicated to providing solutions and services throughout the upstream process to help our clients advance and accelerate their project studies, primarily in the following areas:
Including the selection of host cells, expression vectors, and transfection methods.
Creative Biogene's media development process consists of a screening process to identify important components, followed by optimization steps and process validation. Our optimization strategy is based on component titration, media mixing, spent media analysis and automated screening.
We select the appropriate process for our customers based on product requirements, available facilities and experience, including batch replenishment or continuous feeding processes. We work to define optimal operating parameters including temperature variation, gas exchange, shear stress, transfection process, feeding strategy, incubation duration and infusion rate to achieve high quality product production.
Creative Biogene has a selection of disposable reactors in different designs, such as wave, orbital shaken (OS), stirred tank (ST), and pneumatically mixed bioreactors. They eliminate the need for cleaning or sterilization, thus significantly reducing contamination rates.
Creative Biogene offers a variety of advanced technologies for upstream process development, bringing high yields and cost-effective approaches to biologics production.
| Technology | Description |
| High-throughput cultivation systems | Includes multi-well plates and small bioreactors. Using these HTPDs, it is easy to perform all screening experiments, including optimizing the process to save time and cost, before moving on to scale up recombinant protein production. In addition, we have built and improved batch and make-up-batch process optimization using HTPDs. |
| Single-use cultivation technologies | Single-use (SU) cultivation systems has led to rapid developments of upstream processing. Many different varieties of disposable culture systems including wave, orbital shaken (OS), stirred tank (ST), and pneumatically mixed bioreactors have been used by Creative Biogene for upstream process development. |
| Design of experiments approach | We utilize Design of Experiments (DoE) methods to study various process parameters in biologics manufacturing processes to minimize experimental work in upstream process development and shorten process development time. |
| Quality by design (QbD) approach | QbD is a manufacturing principle in which product quality is integrated into the manufacturing process. The QbD approach has been implemented by Creative Biogene for process development and analytical characterization of recombinant proteins, including monoclonal antibody. |
| Perfusion culture process | Novel cell retention technologies, such as alternating tangential flow (ATF) filtration, have been developed and used in perfusion bioreactors for recombinant protein manufacturing as well as the most commonly used TFF and spin filters. |
| Process analytical technology (PAT) for upstream processes | Effective process optimization requires real-time monitoring of different process parameters. Creative Biogene designs, analyzes and controls manufacturing by regularly and/or continuously measuring key quality and performance attributes, thus ensuring that the final product quality meets the specifications of the process. |
As a leading CDMO manufacturer, from high-quality cell culture products to scalable production processes, Creative Biogene can help you design and develop upstream production processes that increase productivity, optimize product quality, and simplify your operations. 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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