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January 15, 2010 (Vol. 30, No. 2)

Outsourcing Bioproduction Processes

Right Partner Can Provide a Number of Benefits Including Flexibility and Cost Reduction

  • Further Partner Considerations

    Outsourced process optimization can require more collaborative activity than other contracted services, as a result efficient operation requires that a number of cultural and geographic factors be at least considered, if not included, in formal search criteria. Experienced contractors know that expertise is just one characteristic of a partner that is capable of providing timely and successful solutions. For example, efficiency of communication, as well as project-specific management and reporting experience can be as important as technical expertise to the completion of a project on time and within budget.

    Growing demands within the upstream cell-based bioproduction arena have changed the landscape for material and process development. From the advances in process-monitoring technologies to more capable control algorithms, project planners are struggling to keep up with the increased capabilities now commonly demanded. Bioproduction culture media and feeds are now expected to support not only increased cell densities and volumetric productivity but many other functions.

    Thermo Fisher Scientific aggressively addresses these needs by providing total solutions through the integration of cell culture materials, equipment, and services. This begins with the ability to draw upon such immediate capabilities as serum-free media, Single-Use Mixers (S.U.M.), Single-Use Bioreactors (S.U.B.), as well as services provided by the Rapid Response Production and applications development groups. This capability to leverage specific expertise from the broader company at large, such as Thermo Scientific mass spectrometry and protein research products, provides a portfolio of in-house tools to be applied in contracted process optimization.

  • Case Study 1

    Click Image To Enlarge +
    Figure 1A. A batch culture of mAb-producing CHO in a customized SFM, SFM4CHO

    CHO cells are often used for mAb expression. As a result of developments in cloning techniques and media/feeding optimization, production levels from 3–6 g/L are now often expected. Scientists at Thermo Fisher Scientific recently undertook a study to optimize Thermo Scientific HyClone SFM4CHO in order to support the production of over one gram of product per liter with no feeding and minimal process control. 

    Analyses included extensive characterization of spent media, iterative rounds of multicomponent nutrient supplementation following DoE principals, examination of newly published approaches (such as antiapoptotic chemistries), and prior knowledge from related experience. The results illustrate the accumulation of a mAb in simple batch culture to levels in the area of 1–2 grams/L (Figure 1A).

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