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Cell Culture & Expansion Media
Human Serum Albumin
A comprehensive guide to the critical role of albumin in ex vivo expansion media, overcoming serum-derived variability, and Biorbyt's recombinant advantage.
While clinical cell therapies continue to rapidly progress, improvements in the deep understanding of cell culture media components and expansion media design must continue in parallel to attain a highly stringent level of manufacturing process definition and control.
Human Serum Albumin (HSA) is one such critical component. However, while there are already many serum-free cell culture media products incorporating human serum albumin currently available on the market, some of these possess an inherent risk of batch-to-batch biochemical variability. As a result, this can profoundly affect overall media performance and cell viability.
To overcome this variability, Biorbyt offers a superior recombinant human serum albumin produced in highly controlled, nonmammalian-based expression technology.
1. Biological Importance of Human Serum Albumin
Human serum albumin is one of the most abundant protein components present in the plasma of all vertebrates and has been definitively demonstrated to promote the growth and viability of mammalian cells when cultured ex vivo.
Within cell culture environments, human serum albumin is critical because it is:
- Responsible for maintaining the vast majority of the colloidal osmotic pressure in the circulatory system and culture environment.
- Highly capable of safely binding to important hydrophobic molecules (like lipids and hormones) and delivering them across aqueous media directly to cells.
- A highly effective scavenger of damaging reactive oxygen and nitrogen species (ROS/RNS).
- An excellent overall biochemical antioxidant, protecting delicate cell lineages during rapid expansion.
2. Why is Using Serum-Derived Albumin Risky?
Traditionally, albumin used in culture media was derived directly from human or animal blood serum. However, utilizing biologically sourced native albumin introduces significant variables that can jeopardize sensitive cell therapy manufacturing.
Biochemical Inconsistency
Native albumin preparations inherently vary from donor to donor and batch to batch:
- Significant differences in the overall redox state and β-D-glucan (BDG) concentrations exist in native 5% human serum albumin preparations.
- Different commercial albumin preparations contain highly variable levels of Cys34-cysteinylated serum.
- Inconsistent percentages of oxidized vs. unmodified albumins result in significant differences in the RP-UPLC profiles of the final product.
- Variable levels of chemical stabilizers used for the necessary pasteurization of native albumin can inhibit cell growth.
- Different preparations can have variable, truncated polypeptide lengths.
Contamination Risk
Beyond biochemical inconsistency, the inclusion of blood-sourced components into cell culture media carries a severe additional risk of contamination of the final therapeutic product by adventitious agents (such as undetected viruses or prions). Due to these significant risks, a fully recombinant alternative is highly preferred for clinical and large-scale inclusion in cell culture media.
3. Biorbyt's Recombinant HSA: A Reliable Alternative
Biorbyt's Recombinant Human Serum Albumin is totally blood-free and has been optimized specifically to improve performance in animal-free cell culture media due to its favorable lipid profile and other engineered molecular attributes.
It is ideally suited for a variety of different stem, primary, and production cell types that include immune cells, VERO, Mesenchymal Stem Cells (MSCs), HEK, CHO, and other sensitive lineages. Each lot has been rigorously tested in cell culture systems to ensure absolutely consistent quality and performance.
The Recombinant Advantages
100% Animal-Free Manufacturing
Manufactured in a tertiary level animal component-free facility. All raw materials, manufacturing equipment, and packaging are strictly certified animal-free.
Safe Host System
The host manufacturing expression system is of non-animal and non-human origin, eliminating the risk of adventitious blood-borne pathogens completely.
Certified Quality Control
Backed by a strictly certified supply and manufacturing chain. Supplied as a stable lyophilized powder and produced under Certified ISO9001 quality management systems.
4. Available Products
Ensure optimal cell viability, targeted biomarker detection, and robust expansion with our cell culture proteins and highly validated antibodies.
5. Bibliography
- Pennybaker, A., Alfano, R., 2018. Utilization of recombinant albumins in the expansion of human T lymphocytes. CELL & GENE THERAPY INSIGHTS, 231-239. Form: https://invitria.com/wp-content/uploads/2020/09/Utilization-of-recombinant-albumins-in-the-expansion-of-human-T-lymphocytes-1.pdf