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Cell Culture Process Optimization

BioEngine is not only a media products supplier, but also a solution provider for biopharmaceuticals, vaccine production, and cell and gene therapy fields. Based on a large amount of historical data, powerful analytical tools and extensive project experiences, BioEngine can advise you on culture model decisions, process robustness control, product quality optimization, and bioreactor operation enhancement, and ultimately help you achieve or enhance your existing process at commercial scale, creating higher value.

Technology Platforms
Development and optimization technology of serum-free/protein-free medium

It is suitable for the development and optimization of customized serum-free/protein-free medium for large-scale, high-density, suspension culture processes of various animal cells. This technology has been successfully applied to the pilot development and industrialization of many Chinese antibody drug and virus vaccine manufacturers. The specific cell growth rate, maximum viable cell density,  antibody concentration and virus titer are higher than those of global serum-free media.

Establishment and optimization of cell culture process

This technology regulates the physiological state and metabolic network of cells by designing and optimizing the nutrient composition of the medium and process parameters of fed-batch or perfusion strategies, thus improving nutrient metabolism and energy utilization. Compared to the batch process or the previous process, the peak viable cell densities increase significantly, the cell viabilities maintained a high level for a longer time, the product yields improved, and simultaneously, the costs significantly decreased.

Scaling up and intensive operation technologies of animal cell culture process and bioreactor

This technology aims to solve the problems of easy breakage of animal cells culturing in bioreactors and the difficulties on industrial scale-up, and to meet the requirements of process intensification for high-density culture. Through extensive and in-depth scientific research, BioEngine has established powerful technologies for cell culture process and bioreactor scaling-up and enhanced operation, which can effectively prevent the breakage of animal cells. BioEngine has the ability to design and develop bioreactor systems, laying a solid foundation for industrialized-scale, high-density cell culture processes.

Optimization and control of drug qualities and functions

Guided by the Quality by Design (QbD) concept, R&D team of BioEngine made a great effort to analyze the product expression processes at the bioreactor level, cellular level and molecular level, and understand the relationships between protein qualities and process parameters, so as to establish high-yield, high-quality and stable animal cell culture process through rational design and optimization of culture medium and process parameters.

Services and Process

Serviced projects

With four major technology platforms, massive historical data, powerful analysis tools and rich project experiences, BioEngine can provide you with quality services and create higher value.

Typical Cases
Design, development and optimization of culture process Avain influenza vaccine production with suspension MDCK cells Optimization and regulation of key quality attributes of products in culture process Avain adenovirus vaccine production with suspension LMH cells

Design, development and optimization of culture process

Background Perfusion process development for a CHO-K1 cell line

Achievements 1. Cell density maintained at 80-100 ×106 cells/mL (VVD=1), cell viability > 95%;
2. Process lasted for at least 41 days;
3. Acommulative titer reached 48.55g/L/41days, representing 32 runs of previous process;
4. All CQAs such as charge heterogeneity, N-Glycosylation, aggregates, and fragmentation were comparable to RLD.

Highlights 1. 15-fold volumetric titer and over 40 days of expression period, significantly reduced the production cycle;
2. The cost of time, instruments, energy, and staff is remarkably reduced with only a 21% increase in medium consumption;
3. 31-fold decrease in production cycle and instruments requirements and stable product qualities, make it possible to meet the needs of the fast-growing market with competitive products.

Avain influenza vaccine production with suspension MDCK cells

Background Avain influenza vaccine is traditionally produced with embryonated chicken eggs, which is a labor-intense process with poor batch-to-batch consistency. To improve the efficiency and reduce the cost, our customer considered conversion to the suspension cell culture process and scale up to 6000L.

Achievements The production process of avian influenza by suspension culture of MDCK cells was developed in shake-flask system, which was verified to be feasible by testing in 2L bioreactor and the titer was higher than the traditional chicken embryo process. The process was scaled up to the 6000L bioreactor, and the cell growth and drug production showed perfect consistency with 2L bioreactor.

Highlights It is the  avian influenza vaccine production line by using the serum-free suspension cell culture process as long as 2016. The productivity(the HA titer) is 4-8 times of that in the embryonated chicken egg process, and the production efficiency was greatly improved.

Optimization and regulation of key quality attributes of products in culture process

Background Medium and process development of a difficult-to-express fusion protein with an initial titer of only 0.3 g/L. Besides, the level of sialic acid is need to be optimized to avoid decreasing in the late phase of process.

Achievements 1. The sialic acid content and the percentage of glycoforms with sialic acid are increased by 40% and 120%, respectively, which meet the CQA requirements;
2. The titer increased to 3-4 times of the previous process, remarkably reducing the costs;
3. Robust in multiple runs at 1500L manufacturing scale with increased titer and qualified CQAs.

Highlights 1. The loss of sialic acid is commonly encountered in the biopharmaceutical industry. The root cause of this case is investigated in depth and the solution is provided;
2. Significantly increased the titer of a difficult-to-express fusion protein by 3-4-fold;
3. The process is robust at 1500L manufacturing scale with increased titer and qualified CQAs.

Avain adenovirus vaccine production with suspension LMH cells

Background The original LMH cells were adherent and used to produce the avian adenovirus vaccine in the rolling flasks. In the preliminary technical service,  Bioengine helped our customer adapt adherent LMH cells to suspension cells and developed a suspension culture process to produce avian adenovirus vaccine. The production line was scaled up to 1500L bioreactor, and BioEngine participated in the whole process of bioreactor installation, debugging, confirmation of operation, and conducted multiple runs of trial production.

Achievements Pointed out the unreasonable structure of the bioreactors during installation and gave reasonable advice to the bioreactor manufacturer to improve it. Conducted multiple runs of trial production.

Highlights After the sterility verification of 1500L bioreactor system, the first batch of trial production was conducted and successfully reached the standard. The process showed excellent batch-to-batch consistency.

For more successful cases, please contact us

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We have a professional technical team to provide high quality one-stop cell culture service from process development
and optimization, medium formulation design to medium processing and manufacturing for all biopharmaceutical companies.

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BioEngine

3F&4F, Building 3, Lane 396, Lvzhou Ring Road, Minhang District, Shanghai, PRC

(86)21-68582660-2792

globalsales@bio-engine.com.cn

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