Cell Line Development
Efficient High-Quality Cell Lines
An efficient high-quality cell line is the critical first step in any biopharmaceutical manufacturing process. Achieving such a cell line can be a demanding task. It requires precise craftsmanship, requiring both expertise and hands-on experience in process development as well as reliable technology platforms.
Our state-of-the-art facilities provide a global service based on Apollo X™ Mammalian Expression System for efficient cell line development and reliable delivery of monoclonal antibodies and other CHO expressed molecules.
Mammalian Cell Line Development based on CHO
Although there are several options, Chinese Hamster Ovary (CHO) cells have emerged as the gold standard expression system for production of therapeutic proteins. They have an unsurpassed capacity to express a variety of proteins with efficiency. For example recombinant proteins and monoclonal antibody production based on hybridoma cell lines.
We use a DHFR-based selection system. Our main host cell line is a CHO DG44 derived cell line with superior characteristics developed through directed evolution. CHO DG44 cells lack the ability to produce dihydrofolate reductase (DHFR). Metabolic selection that utilizes the DHFR gene provides very efficient and stable expression. This is why it is one of the most widely used techniques in mammalian protein production.
The cells are transfected using a double gene vector to ensure that both DHFR deficiency and the target gene are transferred to the host line. The cells are grown under optimized conditions in a thymidine-lacking, well-defined proprietary medium, developed in-house by FUJIFILM.
Often, very high yields are seen at 10 weeks after transfection. Typically, in the range of 7-10 g/L titre. The key to this success is our ability to identify high productivity clones early in the process and then effectively optimize conditions based on our experience, expertise and a robust technology platform: ApolloX™ Mammalian Expression System.
Apollo X™ Mammalian Expression System
High-quality, efficient cell line development
Apollo X™ is a flexible and scalable cell line development and process development platform designed for efficiency and speed. Typically, product concentrations of 7- 10 g/L are seen about 10 weeks after transfection with the latest improvements.
Apollo X™ is a unique expression platform that was developed in-house by our specialists, based on experience and our long record of accomplishment in cell line development. Simply put, it is designed to take you from pre-clinical investigations to full-scale cGMP production and commercialization as smoothly as possible.
Apollo X™ delivers transfection to RCB in 10 weeks
The latest update to Apollo X™ has allowed us to further reduce the time needed for cell line development without compromising quality. Let us take you from transfection to Research Cell Bank in 10 weeks.Read more
Screening with ambr15™
Improved performance of cell lines using ambr15™
To enable improved and early prediction of the ‘best’ cell lines, state-of-the-art multi-well plate and micro bioreactor systems are utilized to screen cell lines in an environment that is close to that of a production bioreactor. This creates a high probability of success to give a large number of high titer cell lines. The system is operated in fed-batch mode with cells in suspension culture, and deploys ambr™ technology.
Average Titer Improvement
- mAb1: 2.0 x
- mAb2: 1.9 x
- mAb3: 1.4 x
- mAb4: 2.1 x
Average: 1.9 x