9.2. Biotechnological products

Publisher Summary To choose the correct biological system and process steps for expression or production of these biopharmaceuticals it is essential to understand the structural features of the biopolymers that are important to the desired therapeutic activity. A vast number and variety of analytical tools are involved in the structural studies of the products of modem biotechnology such as HPLC in various modes, capillary electrophoresis, mass spectrometry, nuclear magnetic resonance (NMR) spectroscopic techniques, circular dichroism (CD), X-ray diffraction and light scattering studies. Therapeutic biopolymers include monoclonal antibodies (MAbs), interleukins (IL-s), interferons (IFN-s), growth factors (GF-s), tissue plasminogen activator (tPA), erythropoietin (Epo), tumour necrosis factor (TNF) and blood clotting factors. These proteins may be produced by hybridoma cell lines, by genetically engineered cells or by natural producer lines. The end-product of the cell culture or fermentation contains the recombinant product together with impurities which consist of product related degradation products, fragments, or aggregates and contaminants such as host cell proteins, DNA etc.