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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.

The new Apollo X™ offers further reduced timelines from transfection to research cell banks without compromising quality. This is possible because we identified a new line of host cells with superior biomanufacturing potential by directed evolution.

Platform description

The new Apollo X™ offers further reduced timelines from transfection to research cell banks without compromising quality. This is possible because we identified a new line of host cells with superior biomanufacturing potential by directed evolution.

To support this cell line we also developed a new cell culture medium. Moreover, the workflow has been accelerated by automated screening and isolation of cells using Cyto-Mine® and ambr™ technology. In this way, we have been able to remove several classical bottlenecks in cell line development while still ensuring high specificity.

Apollo X™ uses well-characterized CHO DG44 in suspension. Chinese Hamster Ovary (CHO) cells lacking the DHFR enzyme are well recognized as the gold standard mammalian cell line of use for mass production. For example of therapeutic proteins like monoclonal antibodies, vaccines and recombinant proteins. This is because of their stable expression, high transfection efficiency and integration frequency.

The system uses a double gene vector to ensure that expression of the target protein as well as DHFR deficiency is transfected to the cell line. The cell line is grown under optimized conditions in a thymidine-lacking and serum-free defined medium. The process is simple, robust and scalable for every bioreactor size.

The sterile environment at our state-of-the-art cGMP facilities, where continuous validation and controls are carried out, minimizes risks. For example PCR mycoplasma detection, viral clearance and cell line authentication by short-tandem repeat (STR) profiling to prevent cross-contamination.

Apollo X™ is truly ”manufacturing-ready” with a robust support package to aid Investigational New Drug (IND) filing with the FDA.

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Apollo X™ Proprietary medium

A new proprietary medium, specific for Apollo X™ was developed in-house by FUJIFILM to improve titers whilst controlling peak cell density and maintaining high cell viability. Significantly higher titers were achieved with the new medium in our new CHO DG44 host cell line (improved by directed evolution).

Graph Cell line

Fig. Recombinant cell lines from PoC work screened in ambr® 15 using new basal medium and improved process.

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