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European Biopharmaceutical Review

Blood-Free Matters

Since the advent of in vitro mammalian cell culture, fetal bovine serum (FBS) has been used to propagate cells ex vivo. FBS, when added to a basal media, provides facilitation of cell adhesion via extracellular matrix proteins, stimulation of cellular proliferation by the presence of growth factors and nutritional support through the presence of sugars, amino acids, and other undefined components (1). Thus, FBS has proven to be a vital facilitator in the progress of biological research through the years via the establishment of critical in vitro cell culture systems.

Although the addition of FBS to cell culture systems has broadly been adopted, its removal for R&D, as well as the expansion of cells and cell-derived products for therapeutic applications, has been recognised as a high priority among cell culturists for several reasons. Primarily, the introduction of an undefined substance to defined in vitro systems brings an unacceptable degree of unpredictability. Studies have demonstrated that different lots of serum can vary in concentration of known components in some cases more than 10-fold in addition to the variable presence or absence of undefined components (2). This type of variability can have profound effects on the outcome in cell culture systems (3).

Further, due to the degree of utilisation of FBS combined with absence of exact annual production volumes, adulteration and fraud has been wellnoted in the serum industry. In 1994, 30,000L of FBS were documented to be sourced from New Zealand. However, the country itself only reported 15,000L in annual production (4). A second major adulteration case in 2013 was recorded with the dilution of FBS with bovine albumin, water, and other growth promoting substances by a major global supplier (5). Subsequent investigations by the FDA concluded that approximately 280,000L of FBS were affected between 2008-2013 (5). In recent years, the progression of novel cell-based therapeutics from the research lab to the bedside has only further exacerbated the major issues with FBS. Primarily, largescale production of these novel therapies has further strained the already stretched FBS supply. Additionally, the presence of undefined factors in the expansion and production media can cause undesired phenotypic drift in the cell products, which could cause variable potency profiles of the final product that may be difficult to predict and control (6). Finally, since FBS is an animal-derived substance, patient safety is a persistent concern via the potential presence of adventitious agents (7).

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Dr Randall Alfano is the Vice President of InVitria Product Development. He joined the company in 2012 and currently leads the product development team, where he utilises his expertise in media design and optimisation for biomanufacturing and stem/primary cells. Previously, Randall was promoted from Postdoctoral Fellow to Senior Scientist at the Cancer Research Institute of Scott and White Hospital where he developed in vivo animal models for metastatic prostate cancer and was instrumental in developing thorough in vitro and in vivo models for immunostimulatory antigens. He received his PhD from the Texas A&M Health Science Center College of Medicine, US.
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