Bioprocess refers to the production of therapeutic drugs based on biological products. Because of their complexity in terms of composition and structure, those products can only be manufactured in living systems or are themselves a living system.
The production of antibodies requires multiple steps. A first initial production step itself during monoclonal or polyclonal antibodies are produced can then be followed by an optimization, affinity maturation or humanization step, depending on the ultimate usage of the antibody.
Downstream processing (DSP) refers to the recovery and purification of biosynthetic products from natural sources such as animal or plant tissues or recombinant expression by cellular systems. DSP includes the recycling of recoverable components and the appropriate treatment of byproducts.
Protein production techniques include several methods such as the production of recombinant proteins in different organisms (bacteria, animal or plant cells) or a synthetic production using synthesizers. Applications of protein production are wide, from enzymes production to the de novo generation of specific ligands.
All organic production processes are subject to high quality standards. This implies that the finished products must be purified and usable as medicines. A particularly important parameter to check is the absence of host cell proteins (HCP) at the different stages of production, which can be addressed by the use or development of ELISA kits.
Upstream processing refers to the elements involved in the first step of biomolecule production. Thus, different techniques such as biocatalysis or fermentation are often involved. Methodologies specific to the production of exosomes or lipopolysaccharides, for example, require special know-how.