Pharmaceutical and Nutraceutical active ingredients can be produced by fermentation process using specially developed microorganisms.
The key elements of fermentation development are strain selection and optimisation, process development, and finally, scale-up to maximise productivity. Downstream processing utilises various technologies for extracting, concentrating and purifying the product from a dilute fermentation broth.
Although it is not a new technology, microbial fermentation is now the preferred production method, with the advantage of being often environmentally friendly and offering a competitive alternative – in terms of quality and cost – to traditional manufacturing processes such as extraction from natural sources and chemical synthesis.
Under cGMP fermentation procedures, quality is built into the entire process ensuring that regulatory agencies requirements are met in terms of safety, product identity, quality and purity.
Focusing on its expertise and core competencies in microbial fermentation, Gnosis has identified the following three main areas of development:
Some time ago, in the pharmaceutical and ingredient industry, bacteria were considered enemies to be struggled in order to prevent their insinuation into batches and then their deliver to consumers. Bacteria in products meant adulteration, sick consumers, with consequent penalty payments from regulation agencies.
The discovery of probiotics changed this situation. The World Health Organization (WHO) gives to probiotics the following definition: "Live organisms, which, when administered in adequate amounts, confer a health benefit to the host".
There are several active compounds that are naturally produced by microorganisms.
Most of antibiotics are produced by a number of microorganisms and inhibit the growth of other microorganisms, even at very low concentrations. As such, the antibiotics have found extensive application in chemotherapy, plant pathology, food preservation, veterinary medicine and as research tools in biochemistry and molecular biology.
About 7000 antibiotics are currently known and about 100 of these are commercially produced by microbial fermentation process.
The constant demand for new, safe, effective and, if possible natural, ingredients from the global pharmaceutical and supplement industry are pushing manufacturers to look for new ways. In the future, more and more natural ingredients will be produced by microbial fermentation; and these ingredients will partially replace products that are chemically synthesized or extracted from plants or animals.
Plant and animal extraction in fact is one of the 21st century challenges for the healthcare market. Due to globalization, the product supply chain is highly fragmented and it is becoming very difficult to control the source of active compounds.
Consumers should face new safety issues and new diseases. TSE/BSE and contamination of heparins are consequences of the lack of control of the supply chain.