Biotechnology-derived vaccines

Biotechnology-derived vaccines that do not induce an immune response in lower species may have to be tested in a primate species, such as the cynomolgus monkey. A study design in the monkey has been suggested for this purpose (6), based on a proposed developmental toxicity study design for monoclonal antibodies (7). 

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... 

Includes vaccines but more relevant to other biologies International Conference on Harmonization (ICH) S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals 1997... 

Inorganic membranes have been mentioned in other usage in the biotechnology and pharmaceutical industries. For example, ziiconia and alumina-based ceramic membranes have been incorporated in the following operations [Cueille and Ferreira, 1989] purification and concentration of antibiotics, vitamins, amino-acids, organic acids, enzymes, biopolymers and biopeptides for the fermentation steps in the more conventional applications human blood derivatives, vaccines, recombinant proteins, cells culture and monoclonal antibiotics in newer applications and pyrogen lemoval for ultrapure water. 

Figure 6-3 Yearly approvals of biotechnology-deriv drugs and vaccines.

Biotechnology-derived products may be classified into monoclonal antibodies, gene therapy, vaccines, enzymes, and interleukins. The current major therapeutic areas for these substances are cancer or cancer-related conditions, AIDS or HIV-related disease, diabetes, human growth hormone, myocardial infarction, and inflammatory disease. 

Modern biotechnology has resulted in the production of a great variety of pharmaceutically active proteins (1). Recent statistics show that the Food and Drug Administration (FDA) has approved 130 biotechnology-derived protein medicines and vaccines (2). The unfavorable biopharmaceutical properties of these protein drugs, however, have severely hampered their therapeutic and clinical application. First of... 

Biotechnology-derived pharmaceuticals or biopharmaceuticals (BPs) are molecules such as monoclonal antibodies (mAb), soluble/decoy receptors, hormones, enzymes, cytokines, and growth factors that are produced in various biological expression systems and are used to diagnose, treat, or prevent various diseases (International Conference on Harmonization (ICH) S6(R1) 2011). Other types of novel therapeutics, such as vaccines and oligonucleotides synthesized by bacterial or mammalian cells, are also considered BPs according to the ICH S6 (Rl) guideline. 

Marafino BJ, Pugsley MK (2003) Commercial development considerations for biotechnology-derived therapeutics. Cardiovasc Toxicol 3 5-12 Matsumoto M, Komatsu S, Tsuchimoto M et al (2014) Considerations for non-clinical safety studies of therapeutic peptide vaccines. Reg Pharmacol Toxicol 70(l) 254—60. doi 10.1016/j. yrtph.2014.06.029)... 

The Center for Biologies Evaluation and Research (CBER) at the Food and Drug Administration (FDA) is responsible for the regulation of over 85% of the biotechnology-derived medicines/vaccines currently in development in the USA. 

Center for Biologies Evaluation and Research (CBER). This center is responsible for the regulation and approval of ah biological products intended for use in the treatment, prevention, or cure of diseases or injuries to humans. A biological product is any vims, therapeutic semm, toxin, antitoxin, vaccine, blood or blood component or derivative, or analogous product (5). It also includes products produced by biotechnology, such as interferons and erythropoietins. 

A biomolecular system of glycoproteins derived from bacterial cell envelopes that spontaneously aggregates to form crystalline arrays in the mesoscopic range is reviewed in Chapter 9. The structure and features of these S-layers that can be applied in biotechnology, membrane biomimetics, sensors, and vaccine development are discussed. 

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