Ask the Expert – Incorporating recombinant proteins to produce blood-free media formulations for therapeutic cell types

By on March 12, 2018
Ask the Expert

Inclusion of human plasma or plasma-derived proteins, such as albumin and transferrin, in cell culture systems produce media with acceptable performance at small scale. However, scale up to clinical manufacturing with these components proves to be more difficult. Most often plasma or plasma-derived components need to be screened prior inclusion in manufacturing processes as these raw materials often induce unacceptable variability in the final cell product. These variabilities often manifest in unexpected cell or cell product yield or unwanted drifts in the expected phenotype or function of cell or cell-based products. Further, the inclusion of human plasma or plasma-derived components introduces the risk of contamination from adventitious agents.

Advances in recombinant protein expression has produced recombinant versions of serum albumin and transferrin that are both biologically active as well as economically viable. Incorporation of these proteins can produce media formulations that may simplify research and development through the higher degree of chemical definition as well as to facilitate the regulatory approval process for clinical products due the absence of blood-derived components. However, successful incorporation of these recombinant proteins to produce fully animal component free formulations requires further formulation work to replace undefined biologically active compounds that are present in native protein preparations. Haphazard substitutions of these recombinant proteins into formulations that are designed for serum-derived proteins may produce less active media formulations, thereby often resulting in a quick revert. This technical challenge in incorporating these recombinant proteins is only further exacerbated by the ease of use of native derived proteins.

This week InVitria presents Randall Alfano, Ph.D., Vice President of Product Development, as an industry expert in the application of recombinant albumin and transferrin for the expansion of primary, stem, and biomanufacturing cell types. InVitria has been successful in helping clinical development phase vaccine, stem, and immunotherapy groups to remove all blood-derived components from the manufacturing processes by formulating custom blood-free media formulations that have been designed around recombinant albumin and transferrin.

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