Fermentation biopharmaceutical from

Purification of biopharmaceuticals often involves the removal of materials with physical characteristics very similar to the desired product, such as failure sequences from DNA synthesis or misfolded proteins from bacterial fermentations. The contaminants, however, may have biological characteristics very different from the desired product, including different antigenicities, bioactivities, and specificities. There are even systems in which the... 

Analytical scientists will provide support for many of the activities in a biopharmaceutical company. They are responsible for characterizing the molecules in development, establishing and performing assays that aid in optimization and reproducibility of the purification schemes, and optimizing conditions for fermentation or cell culture to include product yields. Some of the characterization techniques will eventually be used in quality control to establish purity, potency, and identity of the final formulation. The techniques described here should provide the beginning of a palette from which to develop analytical solutions. 

The ELISA is a versatile method that can be used throughout the biopharmaceutical product development process, from small-scale research to cell-line selection, to monitoring fermentation and downstream processing, and to product release testing. The use of the microtiter plates allows for high sample throughput and various degrees of automation. ELISAs satisfy the biopharmaceutical production requirements for specific, accurate, precise, and reproducible assays. 

The ELISA can be used for identification and quantitation of the protein product (biopharmaceutical) of interest throughout the development, production, and manufacturing process. For example, in the initial development phase, ELISAs can aid in the selection of the best cell line. In the early manufacturing steps, it can be used to identify the appropriate product-containing pools or fractions in process to be subjected to further purification. Because of the selectivity of ELISA, it is a suitable tool to select out the protein of interest from complex protein mixtures, such as cell culture fermentation media or product pools in early steps of protein recovery as well as downstream processing. Even complex mixtures do not require much sample preparation. It is important to determine... 

The biopharmaceuticals sales are about 45 billion and represent 10 percent of the total pharma market. Today, 25 percent of new drugs are biopharmaceuticals. Since the introduction of insulin over 25 years ago, 160 biopharma products, ranging from proteins, monoclonal antibodies, and nucleic acid-based products, have been approved for use. In 2004 alone, 12 new biopharmaceuticals have been approved, of which only 3 are produced by microbial fermentation, as cell culture is the preferred method for production of biopharma drugs. 

Biopharmaceutical products consist of a multitude of compounds and structures with most having different physical and chemical properties and derive from a large variety of sources like human and animal tissues, body fluids, plant material [237], and as illustrated above, microbial fermentations. Accordingly, purification strategies have to be developed individually and empirically that reflect the physicochemical properties of the product, of the product source, and of potential contaminants by finding appropriate sorts, sequences, combinations, and operation... 

J. Knablein, Biotech A New Era in the New Millennium - From Plant Fermentation to Plant Expression of Biopharmaceuticals, PDA International Congress, Prague, Czech Republic, 2003. 

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