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Technical Services
Customised Media Formulation Development

Customized media development services can help increase titer, improve protein quality, and reduce drug discovery and commercial production costs.

With strong R&D capabilities, a large library of in-house media formulations and a high-throughput screening-based iBioG-Med serum-free media development platform, BioEngine can provide a series of customized services, such as medium formulation development for specific projects, process enhancement for fine-tuning and controlling of critical quality attributes (glycoform, charge heterogeneity, acidic peaks,  fragmentation, sialic acid, etc.) of drugs, and production of customized media. BioEngine can not only quickly obtain high-performance medium formulation, which can increase the efficiency by 30-50% compared with traditional strategies, but also accurately identify key components and quickly determine the effective concentration range, providing scientific basis and guidance for quality control of subsequent commercial production of dry powder medium.

Advantages
  • 30 years of experience in cell culture technologies

  • Large library of cell culture media formulations

  • In-house iBioG-Med platform for medium development

  • Abundant project experiences
    60+ customized development projects, 30+ clinical projects

Services and Process
Available services

Customization of platform culture medium for platform cell lines

Customization for specific projects

Adjustment of medium components to optimize the ratio of glycoform

Adjustment of medium components to optimize charge heterogeneity

Adjustment of medium components and process parameters to optimize the ratio of acidic peaks

Adjustment of medium components to optimize the level of high-mannose glycoforms

Adjustment of medium components and process parameters to optimize fragmentation levels of monoclonal antibody

Adjustment of media components and process parameters to optimize the sialic acid levels of fusion proteins

Other custom development services and optimization projects

Serviced projects

Serving

Biosimilars and innovative drugs (Monoclonal antibody/multi-specific antibody/Fc fusion protein)

Traditional targets (CD20/HER2/PD1 etc.) and new targets (CD38/IL6 etc.)

Typical cases
Platform serum-free medium development for two CHO-K1 cell lines (pre-IND) Customized medium development for a CHO-K1 fed-batch process (process change, 2000L) Customized medium and process development for a mAb production process (phase III, 1500L) Optimization of N-glycosylation by adjustment of medium component, fed-batch process

Platform serum-free medium development for two CHO-K1 cell lines (pre-IND)

Customer ExpectationsSerum-free, 50% increase in titer, suitable for both ATCC's and Merck's CHO-K1 cell lines

Achievements1. The performance in cell growth is equal to or superior to the previously used brand medium;
2. Maximum titer is up to 12.9 g/L, a 50% increase compared to the reference medium;
3. Generally applicable for both ATCC's and Merck's CHO-K1 cell lines, and over 10 quality indexes of products have been tested and shown equal or better results.

Customized medium development for a CHO-K1 fed-batch process (process change, 2000L)

Customer Expectations A set of customized medium products, 30% increase in titer, CQAs comparable with the RLD

Achievements 54.8% increase in titer, CQAs comparable with the RLD

Customized medium and process development for a mAb production process (phase III, 1500L)

Customer Expectations Serum-free medium and production process, titer increase to over 3g/L with the equal quality compared with RLD

Achievements1. Peak viable cell density increased to 3-fold;
2. Cell growth rate and cell viability kept higher levels than in the previous process;
3. Titer increased to 2-fold;
4. Comparable protein quality with RLD.

Optimization of N-glycosylation by adjustment of medium component, fed-batch process

Customer Expectations The sialic acid content increase by 30%,  titer increase to over 4g/L, CQAs comparable with in the previous process.

Achievements 1. Peak viable cell density increased from 8.6×106 cells/mL to 10.7×106 cells/mL;
2. 37% increase in titer;
3. 42% increase in sialic acid content.

For more successful cases, please contact us

Let us contact you

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.

If you have any question, please click "Quick Message" and leave your message,  we will reply to you as soon as possible.
If anything urgent, please call (86)21-68582660-2792.

BioEngine

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

(86)21-68582660-2792

globalsales@bio-engine.com.cn

Work hours:9:00-17:00