Fine chemicals are complex, single, pure chemical substances, produced in limited quantities in multipurpose plants by multistep batch chemical or biotechnological processes. Since their inception in the late the molecules of life physical and chemical principles free pdf, fine chemicals have become an important part of the chemical industry. 40 among in-house production by the main consumers, the life science industry, on the one hand, and the fine chemicals industry on the other hand.
In the subsequent years, the business developed favorably and Lonza was the first fine chemical company entering in a strategic partnership with SKF. The growing complexity and potency of new pharmaceuticals and agrochemicals requiring production in multipurpose, instead of dedicated plants and, more recently, the advent of biopharmaceuticals had a major impact on the demand for fine chemicals and the evolution of the fine chemical industry as a distinct entity. The generally accepted threshold between LMW and HMW is a molecular weight of about 700. As aromatic compounds have been exhausted to a large extent as building blocks for life science products, N-heterocyclic structures prevail nowadays. Big molecules, also called high molecular weight, HMW molecules, are mostly oligomers or polymers of small molecules or chains of amino acids.
Thus, within pharma sciences, peptides, proteins and oligonucleotides constitute the major categories. Apart from pharmaceuticals, peptides are also used for diagnostics and vaccines. 10 billion on the finished drug level, respectively. They are essential to the structure and function of all living cells and viruses and are among the most actively studied molecules in biochemistry. Oligonucleotides are a third category of big molecules.
The small molecule parts, up to four different APIs, are highly potent cytotoxic drugs. A large toolbox of chemical reactions is available for each step of the synthesis of a fine chemical. The most comprehensive handbooks describing organic synthetic methods is Methods of Molecular Transformations. Since the mid-1990s the commercial importance of single-enantiomer fine chemicals has increased steadily.
They constitute about half of both existing and developmental drug APIs. In this context, the ability to synthesize chiral molecules has become an important competency. For peptides three main types of methods are used, namely chemical synthesis, extraction from natural substances, and biosynthesis. In the latter, reagents are incorporated in a resin that is contained in a reactor or column. With the exception of some stereospecific reactions, particularly biotechnology, mastering these technologies does not represent a distinct competitive advantage. Most reactions can be carried out in standard multipurpose plants. Reaction-specific equipment, such as ozone or phosgene generators, is readily available.
The installation generally is not a critical path on the overall project for developing an industrial-scale process of a new molecule. However, the total size of the accessible market typically does not exceed a few hundred tons per year at best. The technology has been used for 10,000 years to produce food products, like alcoholic beverages, cheese, yogurt, and vinegar. Cell Cultures Animal or plant cells, removed from tissues, will continue to grow if cultivated under the appropriate nutrients and conditions. When carried out outside the natural habitat, the process is called cell culture. 150 billion per year threshold by 2015.
The likelihood of developing a new biopharmaceutical successfully is significantly greater than in traditional drug development. Phase I of the regulatory process eventually are granted approval. The traditionally large share of outsourcing. Small number of custom manufacturers with industrial-scale manufacturing capabilities in this demanding technology. Same customer category: life science, especially the pharmaceutical industry. Similar regulatory environment: FDA regulations, especially GMP.
High entry barriers because of demanding technology. 500 million and takes four to six years. As the specifications of the plant and process types for biopharmaceuticals differ substantially from traditional chemical synthesis, they cannot be produced in conventional multipurpose fine chemical plants. Unlike the biopharmaceutical start-ups, the emerging big biopharmaceutical companies are adopting the same opportunistic outsourcing policy as larger pharmaceutical companies.
New developments in expression systems for mammalian and plant cell technology could reduce capacity requirements substantially. 7 by 2015 and once more to 10 by 2020. New transgenic production systems are emerging. Legislation and regulation of biotechnology is not well defined yet and leads to differences in interpretation and other uncertainties. In the US, legislation is not yet in place for biosimilars, the generic counterpart of generics in small molecule pharmaceuticals. The inherent risks of the mammalian cell technology led several companies to opt out of mammalian cell technology or to substantially reduce their stake.
In the latter, which is not used. Produced by custom manufacturing, the raw material consumption and the conversion cost are the two elements that establish the manufacturing cost for a particular fine chemical. And specialty chemical industries, science of Synthesis: Houben, the likelihood of developing a new biopharmaceutical successfully is significantly greater than in traditional drug development. Pure chemical substances, outsourcing is moving up from a purely opportunistic to a strategic approach.