Cell culture technology biopharmaceutical production

As the demand and approvals for biopharmaceuticals grow, the scale of production has to keep pace. Figure 7B.1 shows the steady progress made by different products derived from cell culture technology. 

As described in Section 4.2, traditional biotech processes—namely, biocatalysis and microbial fermentation—are used for the production of small molecules, whereas the modern cell culture methodology allows the production of HMW biopharmaceuticals. A growth rate of 10-15% per annum is expected for the biotechnological contribution, while the average increase of the pharmaceutical market remains below 10%. In terms of technologies, the demanding mammalian cell cultures are expected to grow fastest, followed by microbial fermentation. 

High entry barriers because of demanding technology. The construction of a plant for production of biopharmaceuticals by cell culture fermentation takes about 4-6 years, because it is so technologically, legally and scientifically demanding. Therefore, it must be planned even before the phase II studies begin. 

With product yield at its near maximum, the BEVS community is currently focusing on the improvement of product quality by humanizing insect cell glycosylation patterns. The unique combination of transient expression implementation, high-yield protein production capacity and the prospect of human glycoprofiles in insect cultures indicates a bright future for BEVS technology in the production of biopharmaceuticals [4, 6, 7]. 

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