Cell-Free fields of application
Biomanufacturing consists primarily of synthesising biological products by multiplying cells that incorporate the elements necessary to produce proteins and other specific molecules, thus enabling the mass production of biomolecules of interest.
The production of biopharmaceuticals is currently a major growth area for biomanufacturing and includes the synthesis of antibiotics, monoclonal antibodies, vaccines, enzymes, modified human proteins, growth factors and viral vectors, for the treatment of various diseases, for which these products have high specificity and efficacy, associated with lesser side effects.
The therapeutic molecules are manufactured from living organisms such as animals, plants, microorganisms and/or by biotechnological methods, including recombinant DNA techniques and cell extracts. Non-human mammalian cells are commonly used on an industrial scale, although some human cell lines can be used in vitro. In addition, cell-free systems based on the use of cell lysates are becoming an important alternative to cell-based systems for the synthesis of various therapeutic biomolecules, as they offer several distinct advantages, such as the possibility of producing proteins that would be difficult or impossible to obtain in living systems, due to their cytotoxicity or due to particular structural characteristics.
Over the last 30 years, enormous progress has been made in biomanufacturing technologies and various biopharmaceuticals have been launched on the market. The bioproduction of monoclonal antibodies, for example, has already reached a point of maturity. Furthermore, average yields achieved by commercial-scale manufacturing processes with mammalian systems, lie in the range of 70-80%. Downstream processing technologies (including purification) have become more efficient, enabling smaller overall volumes and single-use approaches. It is now easier and faster to establish stable cell lines and cell banks. Nevertheless, the biomanufacturing of certain cell and gene therapies still needs to be improved to reach full maturity.