Incorporating recombinant proteins to produce blood-free media formulations for therapeutic cell types

Sponsored by: InVitria
Session ends: March 16th, 2018, 3:00pm MST
Answers by: Randall Alfano, Ph.D, Vice President of Product Development, LiInVitria


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.


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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.

If you have any questions around the incorporation of recombinant albumin and transferrin or the formulation of custom blood-free media formulations, feel free to reach out and ask a question.


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Questions & Answers

Are these supplements or are these formulated into the media. Do your proteins need to be added during culture or just in the beginning?

InVitria offers recombinant versions of critical components that are often sourced from human serum, albumin and transferrin. These components, known as Cellastim S (albumin) and Optiferrin (transferrin) are incorporated into complete media formulations that also include recombinant insulin found in ITSE and animal free cytokines that are specific to the cell type of interest. These […]» Read More

For which primary cell lines have you been able to create a blood-free media? Do you find that different cell lines require varying levels of albumin/transferrin?

The levels of incorporation of both recombinant albumin and recombinant transferrin will vary depending on the cell line. I would invite you to visit and download the cellastim-s  and optiferrin product bundles. These bundles contain suggested incorporation levels of both recombinant albumin and transferrin for an array of different primary, stem, and biomanufacturing cell […]» Read More