Today a large number of newly approved medications are manufactured using biotechnology. The new production methods being implemented as part of this process, e.g. involving single-use components, also require new process analysis tools. One of these tools, which is used in combination with statistical analysis methods, is NIR spectroscopy.
Red biotechnology, i.e. medical biotechnology for the production of active ingredients using genetically modified organisms, is mainly responsible for the production of three target product groups: monoclonal antibodies, therapeutic proteins and vaccines. Modified prokaryotic cells, such as bacteria, generate less complex active ingredients. One of such examples is recombinant proteins, e.g. insulin. Complex protein structures, such as antibodies, can only be manufactured using modified mammalian cells. Thus, a distinction between the processes is made primarily based on the type of organism involved: Those which use microorganism-based fermentation (MO) and those using animal cell cultures (CC). The type of process and the respective equipment and methodology requirements vary enormously.
Quick Bioprocesses Pose challenges for Process Analytics
Due to high division and metabolic rates, MO processes, for example the fermentation of genetically modified bacteria such as E.Colior Bacillus, are completed very quickly, with new batches being produced within a few days. The medium in which the fermentation process takes place is usually complex and includes a wide variation of primary and secondary sugars as a source of carbon. Furthermore, a nitrogen source is also added, for example a yeast extract or a peptone (a mix of peptides and amino acids). Due to the high metabolic rate, these types of system are vigorously stirred and kept well-supplied with oxygen.
Monitoring Slower Bio–Processes
CC processes are less frantic: Processing periods for animal cell cultures can range from several days to a number of weeks. Fully chemically-defined media are used for this. Using a pH buffer as a base, trace elements, vitamins and amino acids are added which have been specially adapted to the organism in use.
Glucose and glutamine are used as nutrient sources. The level of agitation is much more moderate, since the organisms’ size and their cell membranes make them susceptible to shear stress.
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