Despite the diversity of biological pharmaceuticals, protein-based therapeutics account for the vast majority of biologics — either approved or under development. Of the protein-based biopharmaceuticals, recombinant proteins are the largest group, which consists of enzymes, hormones, blood factors, monoclonal antibodies (mAbs) and antibody related products (Fc-fusion proteins and antibody fragments).
To date, there are around 650 approved protein therapeutics worldwide, including more than 400 recombinant products.1 Additionally, the development pipeline for protein-based biologics is fairly strong; 1300 candidates are under development, 33% of which are at various phases of clinical trials. With respect to mAbs, more than 30 therapeutic mAbs have been approved and more than 350 of them have entered clinical trials.2
The rapid growth of therapeutic recombinant proteins owes a great deal to technological advances in expression vector design, cell line engineering and clone screening.
The main goal in recombinant protein development is to generate a monoclonal cell line that is stable and consistently expresses the given recombinant protein at a high quantity and the desired quality, through an efficient and cost-effective manufacturing process.
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