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Eminence: Facilitating The Development of Personalized Medium Formulations

Views: 0     Author: Site Editor     Publish Time: 2023-05-23      Origin: Site

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Driven by emerging technologies, substantial progress has been made in the development of CD media for CHO cells over the past few decades, with the recombinant protein expression level exceeding 10 g/L in some cases. Compared to off-the-shelf options, customized or highly personalized media offer significant advantages, with the key lying in the strategies for formulation selection and optimization. Customized or highly personalized media allow for effective process optimization, elimination of influencing factors, and a better understanding of the impact of individual components on medium quality.

Personalized medium development services offered by Eminence can assist you in increasing cell expression levels and the quality of proteins and antibodies in the process of drug research and development, and reducing the costs associated with commercial production.

The technical team at Eminence boasts over 20 years of experience in developing medium formulations. We provide biopharmaceutical institutions with customized services including personalized customization of platform growth media, development of tailored formulations for individual projects, quality control of key indicators (glycosylation, charge heterogeneity, acidic peaks, fragmentation, sialic acid, etc.), and production of customized media.  

Eminence utilizes high-throughput screening technology to enhance the efficiency of media development by 30-50% compared to conventional strategies. This approach not only allows for the rapid development of the most suitable growth medium formulations in the shortest possible time but also enables accurate identification of key components and rapid determination of effective concentration ranges, providing a scientific basis and guidance for quality control in the subsequent commercial production of powdered media and ensuring the feasibility of large-scale production and delivery.

Eminence currently possesses a medium library consisting of hundreds of independently developed medium formulations. Based on the medium library and relying on the orthogonal experimental design, statistics, and big data analysis, we have established an advanced high-throughput medium development platform equipped with state-of-the-art Vantage high-throughput liquid handling workstations, metabolic monitoring analyzer and high-throughput ForteBio, etc.


Figure 1: Hamilton Vantage Automated Liquid Handling Platform

This platform can be used for the development of personalized medium formulations, which greatly reduces human errors, improves experimental efficiency and accuracy, and achieves rapid development of personalized media for target cells to meet the customers’ needs for cells/products. Meanwhile, it greatly shortens the development cycle of customized formulations from 12 months to 3-6 months, and eliminates the shortcomings of traditional development such as experience-based concentration selection, information omission and wastes.


Figure 2: Eminence’s Personalized Medium Formulation Development Process

With the advanced liquid preparation software system and Eminence's rich experiences in medium component concentration selection, and automated liquid preparation, etc., the accuracy and repeatability of experimental results are greatly improved, and the time for formulation development is shortened. In addition, Eminence can perform 24-DWP, 96-DWP, and TPP suspension culture on a high-throughput shaker, and achieve high-throughput metabolic detection, high-throughput detection of cell viability & viable cell number with microplate reader, and high-throughput detection of exocytic protein expression with Fortebio; thus the critical components of the culture medium are rapidly screened for concentration optimization, which greatly reduces the workload of experimental personnel, accelerates the development of culture media, and ultimately meets customers' expectations for yield and quality.


Figure 3: High-performance Liquid Chromatograph


Figure 4: 8-channel Octet RED96e

After the component optimization and formulation development, Eminence’s professional process team and the manufacturing department will conduct testing on dry powder, and pilot batch testing before mass production to ensure that the developed liquid medium formulation can be used for dry powder and mass production.

In addition, Eminence can provide optimization services for increasing the yield for the existing preliminary process projects. By replacing/preparing culture media and/or feed combinations, adding/reducing medium components and adjusting culture processes, etc., the cell line potential is discovered and the expression level of target proteins is increased.

Eminence has rich experience in quality control of critical parameters (glycoforms, charge heterogeneity, acidity peak, fragmentation, sialic acid, etc.). By searching and comparing culture data with historical project data, the potential key influencing factors are searched, considered and verified through DOE PB or RS design, and target quality parameters are adjusted to optimize expression and meet customers' needs.


Figure 5: Eminence’s High-performance Cell Culture Medium Formulation Development Service Process

By following the high-quality system management, Eminence can ensure provision of flexible and diverse solutions to fully meet customer needs. It has offered assistance to many customers in the medium development required for the research and development of innovative drugs and generic drugs.

Eminence offers optimization and development of medium formulations, as well as customized medium production, to meet the personalized needs of customers for cell culture media. So far, Eminence has accumulated rich experiences in the dozens of customized development services and changes in numerous clinical projects and marketing projects.

Eminence possesses a wealth of historical data, a powerful high-throughput development platform, and extensive project experience. Leveraging these resources, we provide recommendations on culture mode decision-making, process robustness control, product quality optimization, and reactor operation enhancement, ultimately assisting you in achieving or improving existing processes at commercial production scale, and creating greater value.

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