Cell culture technology refers to the use of specific systems and emergent trends for the in vitro culture of cells under controlled environmental conditions. It is a multidisciplinary area, involving basic concepts of cellular and molecular biology, as well as applied engineering concepts, which has gained prominence in modern biotechnology. Since its establishment in the early 19th century, considerable progress has taken place, making this technology a major industrial platform for the production of therapeutic products such as recombinant proteins, monoclonal antibodies and the cell-derived ones. The characterization of the cellular physiology and metabolism allowed the development of serum-free chemically defined culture medium formulations and also the design of high-yield processes by using fed-batch and perfusion feeding scheme. Disposable single use bioreactors are now available enhancing the safety and the quality assurance of the processes and products, thus faciliting the regulatory approval. Manufacturing costs are the major barrier to the widespread implementation of cell-based and cell-derived products, mainly due to the bioprocess complexity, specific culture conditions and the requirement of GMP area (maintenance-associated costs). As a result, the search for economically viable production processes has been extensive explored and represents a great challenge to be faced. Bioprocess engineering fundamentals, including bioreactor design and process control, have been systematically used for the robust and cost-effective production of a wide variety of therapeutics. The aim of this Research Topic is to present a comprehensive overview of the state-of-the-art in cell culture technology for the production of protein-based (biopharmaceuticals) and cell-based therapeutic products. It will cover recent advances in strategic fields such as molecular biology, cell line development, bioprocess engineering tools, bioreactor design and operation for biopharmaceuticals production. Bioprocessing aspects related to cell expansion for cell-based therapies will also be considered.

Keywords: Cell culture, bioreactor, scale-up, stem cells, mammalian cells

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