Therapeutic proteins (Biologics/Biotherapeutics) are active biomolecules are derived from a biological source by production in microorganisms or cells (humans and animals) using biotechnology.

Protein therapeutics exhibit complex secondary and tertiary structures that must be maintained to exhibit the desired function. Protein therapeutics cannot be completely synthesized by chemical processes and have to be manufactured in living cells or organisms; consequently, the choices of the cell line, species origin, and culture conditions all affect the final product characteristics. Moreover, most biologically active proteins require posttranslational modifications that can be compromised when heterologous expression systems are used. Additionally, as the products are synthesized by cells or organisms, complex purification processes are involved. Furthermore, viral clearance processes such as removal of virus particles with filters or resins, as well as inactivation steps by changing pH or detergents, are implemented to prevent the serious safety issue of viral contamination of protein drug substances.
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