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Monitoring and controlling of processes is the highest concern for businesses in any industry. To produce the best quality and get a maximum efficient product, the effective methods of monitoring are necessary. Biotechnology processes are useful in developing various types of products like primary and secondary metabolites, vaccines, tissues, and cells. In modern biotechnology, various host cell systems are used, such as bacterial cells, plant cells, and eukaryotic cells, with precise requirements for the design of bioreactors, media composition, and process control.
The value of the continuous approach is proven with the possible chromatographic improvements. In the production of new medicines, chromatography systems have been critical for many years. The technology is well established, and many manufacturers have reluctantly opposed the status quo, but the potential for enormous cost savings leads to a foremost shift to continuous chromatography.
As far as regulatory risk is concerned, continuous processing is as risky as batch processing. However, continuous processes reduce the risks to a great extent rather than creating complexity. Based on these advanced instruments, it would be easy for manufacturers to create a good quality of data to show the consistent operation that which is within an acceptable range. These robust datasets are capable of speeding up the clinical approval process and form the basis for a new regulatory approach. Rather than regulators approving every stage of batch processing, more seamless integrated drug approval are possible with continual bioprocessing which will help to increase speed to marketing.
Genzyme and Bayer are some of the leaders in CBP implementations. Amgen, an American multinational biopharmaceutical company, recently opened an integrated CBP a $200 million worth facility in Singapore, and Hemispherx Biopharma is developing an immune modulator cultivated in cells. In addition to the production of recombinant protein and antibodies, continuous bioprocessing is also well suited to the development of cellular, gene therapy and other new product classes.
Ultimately, patients will get the real benefit of a shift to continuous bioprocessing throughout the industry. If traditional batch processing can take up to seven weeks, continuous bioprocessing can deliver the same product within a week. Investing in continuous production bioprocessing is essential for longevity, profitability, and survival, and is the key to finding an efficient way to ensure that the patient can obtain the right medicine at the right time.
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