The supplementation of culture medium with fetal bovine serum (FBS, also referred to as "fetal calf serum") is still common practice in cell culture applications. Due to a number of disadvantages in terms of quality and reproducibility of in vitro data, animal welfare concerns, and in light of recent cases of fraudulent marketing, the search for alternatives and the development of serum-free medium formulations has gained global attention. Here, we report on the 3rd Workshop on FBS, Serum Alternatives and Serum-free Media, where regulatory aspects, the serum dilemma, alternatives to FBS, case-studies of serum-free in vitro applications, and the establishment of serum-free databases were discussed. The whole process of obtaining blood from a living calf fetus to using the FBS produced from it for scientific purposes is de facto not yet legally regulated despite the existing EU-Directive 2010/63/EU on the use of animals for scientific purposes. Together with the above-mentioned challenges, several strategies have been developed to reduce or replace FBS in cell culture media in terms of the 3Rs (Refinement, Reduction, Replacement). Most recently, releasates of activated human donor thrombocytes (human platelet lysates) have been shown to be one of the most promising serum alternatives when chemically-defined media are not yet an option. Additionally, new developments in cell-based assay techniques, advanced organ-on-chip and microphysiological systems are covered in this report. Chemically-defined serum-free media are shown to be the ultimate goal for the majority of culture systems, and examples are discussed.

/pdf/fetal-bovine-serum-fbs-past-present-future-4w1774k1dv.pdf

Fetal Bovine Serum (FBS): Past - Present - Future.

Mesenchymal stromal cells (MSCs) for basic research and clinical applications are manufactured and developed as unique cell products by many different manufacturers and laboratories, often under different conditions. The lack of standardization of MSC identity has limited consensus around which MSC properties are relevant for specific outcomes. In this Review, we examine how the choice of media, cell source, culture environment and storage affects the phenotype and clinical utility of MSC-based products, and discuss the techniques better suited to prime MSCs with specific phenotypes of interest and the need for the continued development of standardized assays that provide quality assurance for clinical-grade MSCs. Bioequivalence between cell products and batches must be investigated rather than assumed, so that the diversity of phenotypes between differing MSC products can be accounted for to identify products with the highest therapeutic potential and to preserve their safety in clinical treatments.

Manufacturing of primed mesenchymal stromal cells for therapy.

Mammalian cell culture for production of recombinant proteins: A review of the critical steps in their biomanufacturing

Alternative to FBS in animal cell culture - An overview and future perspective.

Large-scale cultured meat production: Trends, challenges and promising biomanufacturing technologies

A consensus introduction to serum replacements and serum-free media for cellular therapies

Corrigendum to “A consensus introduction to serum replacements and serum-free media for cellular therapies” [Cytotherapy 19 (2017) 155–169]

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A consensus introduction to serum replacements and serum-free media for cellular therapies

Corrigendum to “A consensus introduction to serum replacements and serum-free media for cellular therapies” [Cytotherapy 19 (2017) 155–169]