Version 8 (v8) Commercial Platform Process
As a leader in technology and innovation for mammalian cell culture, Lonza is pleased to introduce the latest version of our cell culture media and feed platform for the GS Gene Expression System™. This new offering includes Lonza’s proprietary chemically defined, animal component-free (CDACF) Version 8 (v8) Media and Feeds Platform which was designed in conjunction with the GS-CHO cell line.
The new v8 Platform incorporates GS-CHO specific CDACF cell culture medium, feed base powders and supplements and is globally manufactured and supplied by our custom media production facilities. The CDACF v8 Platform has been shown to reach yields up to 9.6 g/L and has also been used successfully with DHFR-CHO cell lines. It is free from both royalty and license fees and is available to all holders of the GS Gene Expression System™.
The Version 8 Advantage:
- Chemically defined and animal component-free (CDACF)
- Developed by Lonza specifically for GS-CHO cell lines
- No royalties or license fees added
- Increased antibody yield
- Improved cellular metabolism
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Overview of Process Platforms for GS
Our new Version 8 (v8) Platform Process was developed specifically to achieve high productivity of GS-CHO cell lines. The platform comprises a new medium, feeds and feeding strategy combined with a new culture pH control strategy. Table 1 shows an overview of the v8 Platform Process as well as the two preceding GS-CHO platforms, Versions 6 and 7. All three platform processes are chemically defined, animal component-free (CDACF) and do not contain proteins.
The data depicted in Figures 1 through 3 show the performance of the model GS-CHO cell line, LB01, in the Version 6, 7 and 8 Platform Processes.
At day 15, an antibody concentration of 6.0 g/L was produced. This represents a 50 % increase compared to the Version 7 process and a 100 % increase compared to the Version 6 process. Antibody production, continued in the Version 8 process beyond day 15, increased to 8.3 g/L at day 19 when the culture was terminated.
Biochemical characteristics of antibodies produced in all three cell culture processes were similar. Further Lonza testing of the Version 8 process at the laboratory-scale has yielded antibody concentrations of up to 8.1 g/L at day 15 and up to 9.6 g/L, when the process duration was extended to 18 days.
To date, Lonza has data for nine different antibodies evaluated at the 10L bioreactor scale: six were produced at concentrations exceeding 5.0 g/L (four of which exceeded 6.0 g L) at day 15 of culture. The Version 8 process was successfully scaled-up to both 400L and 20000L bioreactor cultures. Evaluation at the 20 000L scale is in progress at our Tuas, Singapore develoment facility.