Marketed recombinant proteins vaccines

Recombinant proteins with unique properties can potentially generate new markets and penetrate into existing markets if they can be supplied on a large scale. An ideal system would produce the safest biologically active material at the lowest cost, and would be used in combination with an inexpensive and simple purification process. So far, there have been several examples of the high-yield production of recombinant proteins in transgenic crop plants, mainly in the area of molecular medicines such as antibodies, enzymes and vaccines [45, 48-50]. Modern agricultural practices offer... 

After the approval of the first product, recombinant insulin, in 1982, progress in the development of new recombinant protein pharmaceuticals was slow ([10], Fig. 17.1). The number of biotechnology-derived drugs and vaccines approved by the US Food and Dmg Administration (FDA) has increased significantly only since 1995. More recently, sales of biologies have skyrocketed, e.g. from 900 million in 1999 to an estimated 3.5 billion in 2001 for monoclonal antibodies [11]. The annual global market for biopharmaceuticals is estimated to have increased from 12 billion US to 30 billion US in 2003 [12]. 500 candidate biopharmaceuticals are undergoing clinical evaluation and over one hundred protein-based therapeutics are in the... 

The biotechnology industry has evolved significantly since the introduction in 1982 of human insulin synthesized in Escherichia coli—the first Food and Drug Administration (FDA)-approved recombinant therapeutic agent in the United States. Since then, over 75 other recombinant proteins have been introduced. The list is comprised of cytokines, hormones, monoclonal antibodies, and vaccines. There are more than 1100 companies competing for this market, and the current sale of these products comprises approximately 10% of the sales of all therapeutic products sold in the United States. One such product, erythropoietin, an erythropoiesis-stimulating factor also known... 

There also is a marketed Lyme disease vaccine containing recombinant OspA (31,115,116). The vaccine is a sterile suspension of a noninfectious recombinant vaccine containing an immunodominant outer surface protein of Borrelia burgdorferi known as lipoprotein OspA. The antigen is adsorbed onto aluminum hydroxide as an adjuvant. Vaccine efficacy against definite Lyme disease is 78% after three doses. 

From 1982 (when the first recombinant product was approved) through 2008, there have been 403 approvals of biopharmaceutical products by FDA, including vaccines, blood products, recombinant proteins (including monoclonal antibodies (mAb)), and other biopharmaceuticals. Among these, 103 are recombinant proteins. The market for therapeutic proteins should show double-digit growth over the next few years. 

The modern subunit vaccines, first marketed in 1987, were made by recombinant DNA techniques described earlier in this chapter. Because this vaccine consists solely of the viral surface protein or antigen to which the immune system responds, there is no risk for infection with HBV. 

Since the first product, the recombinant kallilcrein inhibitor ecallantide (KALBITOR , Dyax, USA), was approved by the FDA in 2009, several more followed, mainly being peptides and small proteins. Antibodies and fragments thereof are currently in clinical trials awaiting approval [154]. Several more biopharmaceutical products such as insulin, interferon-alpha 2b, and hepatitis B vaccine are on the market in India and other Asian countries [155]. Apart from biopharmaceuticals, a range of industrial enzymes, among them phytase, nitrate reductase, or lipase, are commercially available. Direct information on the production process is mostly not available, but it can be concluded from journal and patent literature that mostly the AOXl promoter is used in these cases, and other expression systems like the GAP promoter are applied as well. In total, approximately 70 products are on the market, and a list can be found at http // www.pichia.com/science-center/commercialized-products/ [156]. 

Virus-like particles (VLPs) are self-assembling particles ranging in size in the range 20-100 nm they are composed of one or several viral proteins expressed in vitro through recombinant technologies. A VLP-based vaccine for Hepatitis B is currently on the market,as well as a prophylactic human papillomavirus (HPV) virus-like particle vaccine, which has shown clinical efficacy when administered intramuscularly. ... 

---