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
iBioG-Med: Innovative Data Mining Platform
Abundant project experiences: 60+ customization & development projects, 30+ clinical projects
Services and Workflows
Available services
Customization of:
Platform culture media for platform cell lines
Other specific projects
Adjustment of medium components to optimize:
Glycoform ratios
Charge heterogeneity
High mannose glycoforms levels
Adjustment of medium components to optimize:
Ratio of acidic peaks
Fragmentation of monoclonal antibodies
Sialic acid levels of fusion proteins
Other customization and/or optimization projects
Projects
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 Expectations
Serum-free, 50% increase in titer, suitable for both ATCC's and Merck's CHO-K1 cell lines
Achievements
1. 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
Platform serum-free medium development for two CHO-K1 cell lines (pre-IND)
Customer Expectations
Serum-free medium and production process, titer increase to over 3g/L with the equal quality compared with RLD
Achievements
1. 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.
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.