Types of Therapeutic Biologies

Highly diverse in properhes and manufacturing processes, therapeuhe biologies can be loosely categorized into four main groups, as follows, with an eye toward implemenhng the E factor concept. 

1) Peptides These are made up of approximately 20 to 40 amino acids, with molecular weights typically below 5000 Da, and are produced by chemical synthesis, primarily via solid-phase synthesis. The manufacture of pephdes is thus closer to that of small molecules than to biological processes such as fermentahon. 

3) Nucleotides These are polymers of the nucleic acids that constitute genes, and are used as therapeutics for their binding properties or genetic functions. They can be divided into two groups  

4) Vaccines This group represents an entire class by itself with many different forms and functions. They span from the traditional vaccines such as inactivated or attenuated microbes or viruses to peptides, proteins and DNA- to vims-like particles, and usually are in combination with an adjuvant for enhanced efficacy. They are typically produced by fermentahon, except for peptides, which are produced by chemical synthesis, as mentioned above. 

According to a review by Walsh [10], of 165 biopharmaceuhcal products approved in the United States and Europe by 2006, only two are nucleic acid-based drugs, whereas nine of the 31 therapeutic proteins approved since 2003 are produced in E, coli, and 17 are produced by mammalian cell lines. In 2004 market distribution and manufacture of therapeutic proteins, non-glycosylated (non-antibody) proteins constitutes 40% of the total market, with 12% armual growth rate, and are produced in E. coli or the yeast Saccharomyces cerevisiae glycoproteins (primarily mAbs) constitute 60% of the total market, with 26% armual growth rate, and are produced by mammalian cell culture (mostly with cells from Chinese Hamster Ovary, or CHO). 

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