The Impact of Cell Culture Medium on Cell Line and Process Development Timelines and Strategies - Animal-component free (ACF) medium sped up cell-line development by eliminating the adaptation period

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The Impact of Cell Culture Medium on Cell Line and Process Development Timelines and Strategies
Animal-component free (ACF) medium sped up cell-line development by eliminating the adaptation period from serum-containing medium used in early development to ACF medium used for high-titer production.


BioPharm International Supplements


Process Development Strategies and Advantages

The biotechnology industry depends on robust manufacturing cell lines to produce biologics. The timelines for deriving a stable manufacturing cell line suitable for consistent process scale-up requires thorough screening and subcloning of the initial transfectant population. In the case of suspension dhfr– CHO cell cultures, amplification procedures using MTX prolongs this process. However, the recombinant cell lines derived from Expression System II have a more straightforward development time, which can take approximately seven months to adapt from serum-containing transfection to serum removal and subcloning. Through careful development of MTCM medium that can support different activities, we were able to significantly reduce the timeline from transfection to cell line selection for both expression systems (Figure 2). Recombinant cell lines derived from both expression systems can use the same medium without serum right from the transfection stage. Using one medium throughout all upstream process development phases also helps retain the higher productivity carried from early clones by eliminating media shifts.


Table 3. Comparison of MTCM media costs to commercially available media for different manufacturing scales
A robust CHO-based high yielding platform technology was established for HuMAb manufacturing. With this strategy, media inventory became much more streamlined for different process development stages as well as for manufacturing. Basal medium compositions can be manufactured in both liquid and powder formulations that support growth and production equally well. The powder form of both basal and feed media has been successfully manufactured up to the 450-kg scale and shown to be stable for more than two to three years, which has facilitated convenient inventory maintenance for multiple processes of different HuMAb molecules. Powder formulations provide a convenient means of transport and storage of large batches for commercial-scale manufacturing and also decrease the costs associated with testing and releasing multiple media lots. Overall, manufacturing efficiency and timelines are favorably influenced for a wide variety of antibody candidates and also resulted in more operation-friendly processes by using common media requirements for different CHO cell lines. In addition, knowledge of medium formulations provides better insights during upstream process optimization. Furthermore, using in-house media can significantly reduce the manufacturing cost of goods, and medium cost can be lowered as much as 60% compared to commercially available media (Table 3).


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