Biologics manufacturing refers to the production of biologics, which are complex, large-molecule drugs derived from living organisms. These products include viral vaccines, gene therapies, monoclonal antibodies, and recombinant proteins, which are used to treat various diseases such as cancer, autoimmune disorders, and infectious diseases. Unlike traditional small-molecule drugs that are chemically synthesized, biologics are produced through biological processes involving living cells.
The starting point of biologics manufacturing is the cell line development wich consists in the creation of a cell line capable of producing the desired biologic. This involves selecting and genetically engineering cells, such as mammalian, bacterial, or yeast cells, to express the target protein or antibody. This step is generally followed by a clonal selection – according to authorities’ expectations – to ensure a high quality of the product.
Once the clone is selected, manufacture of the desired biologic will require sticking to Good Manufacturing Practices (GMP) through different steps aiming to ensure patient safety. The process begins with the creation of a master cell bank or a master virus seed bank (in case of viral vaccines), which is used to produce working cell banks or virus seed stocks. These working stocks will be then used to produce the final biologic product through various production steps such as growth in bioreactors (upstream), purification (downstream), formulation and fill-and-finish.
Clean Cells is able to accompany its clients at early stages of the project, by performing non-GMP testings to assess the quality of the research material or by providing clonal selection services.
As long-standing expert on cell culture and a cGMP-certified CDMO, our company supports customers with biologics manufacturing needs through cell banking and virus bank manufacturing [1] services together with extensive characterization services and storage options.
