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European Biopharmaceutical Review
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Serum has long been an integral media component of cell culture,
providing a rich source of diverse nutrients vital for successful in
vitro culture. Fetal bovine serum (FBS) is the preferred serum source
for cell culture for several reasons. First, FBS is highly accessible
and accommodating to most cell types and is therefore the most widely
used supplement for mammalian cell culture – including human primary
cells. Second, it consists of a broad spectrum of components like
proteins, growth factors, enzymes and other chemical constituents that
make it ideal for promoting cell health and growth. Third, it provides a
broad spectrum of utility such as attachment and spreading, detoxifying
and transport factors attributed to a serum’s complex structure (1,2).
Lot-to-Lot Variability
Although FBS can be utilised across a wide array of cell types from
various sources (including multiple different species), one major
disadvantage is its lot-to-lot variability, which is also observed in
other serum compositions such as human serum albumin (HSA). This
variability stems from the numerous natural and chemical components that
contribute to its complex structure, which is attributed to the varying
conditions and parameters observed during processing and collection.
For example, inconsistency in batch sizes; the number and age of animals
used; the potential presence of varying amounts of endotoxins; and
other pathogen-associated contaminants can all influence each lot’s
quantitative and qualitative consistency and performance. This
necessitates the regular screening of multiple FBS lots prior to
purchase in order to maintain a consistent experimental and/or
manufacturing output. Additionally, even when the ideal lot has been
identified, the culture effects can still vary from one cell type to the
next. This impacts the ability to utilise a single lot for multiple
applications and poses a challenge for translational and human clinical
studies.
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