Biopharmaceuticals from microorganisms: from production to purification

Abstract

The use of biopharmaceuticals dates from the 19th century and within 5-10 years, up to 50% of all drugs in development will be biopharmaceuticals. In the 1980s, the biopharmaceutical industry experienced a significant growth in the production and approval of recombinant proteins such as interferons (IFN α, β, and γ) and growth hormones. The production of biopharmaceuticals, known as bioprocess, involves a wide range of techniques. In this review, we discuss the technology involved in the bioprocess and describe the available strategies and main advances in microbial fermentation and purification process to obtain biopharmaceuticals.

Keywords: Biopharmaceuticals; Biotechnology; Downstream process; Fermentation process; Upstream process.

Fig. 1

Pipeline of protein engineering to obtain biobetters. The protein is represented by molecular surface and colorized by coulombic forces (blue = positive, red = negative, and white = neutral).

Fig. 2

The biopharmaceutical manufacturing technology flowchart exemplifying the upstream and the downstream bioprocess.

Fig. 3

Recombinant protein production. Using recombinant DNA techniques, the target human gene can be isolated and ligated to a vector (plasmid). The plasmid containing the human gene is used to transform bacterial cells, which are able to produce high amounts of the recombinant protein.

Fig. 4

Commercial biopharmaceutical products approved from 2005 to 2015. Dark green bars represent monoclonal antibody related products and non-related total recombinant proteins are represented in red. The data used concerning the number of biopharmaceutical approvals are available at biopharma biopharmaceutical products (http://www.biopharma.com/approvals).