Guide Biotechnological Innovations in Chemical Synthesis

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Table of contents

Its main disadvantages are low volume productivity and the animal provenance. It is conceivable that other technologies, particularly plant cell production , will gain importance in future. Given the fundamental differences between the two process technologies, plants for mammalian cell culture technologies have to be built ex novo.

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 conclusion, biocatalysis should be, or become, part of the technology toolbox of any fine chemical company. Mammalian cell culture fermentation, on the other hand, should be considered only by large fine chemical companies with a full war chest and a long-term strategic orientation. Within the chemical universe, the fine chemical industry is positioned between the commodity, their suppliers, and specialty chemical industries, their customers.

Depending on the services offered, there are two types of fine chemical companies.


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The Fine Chemical Companies are active in industrial scale production, both of standard and exclusive products. Their product portfolios comprise exclusive products, produced by custom manufacturing, as main activity, non-exclusive products, e. API-for Generics, and standard products. The industry is very fragmented. The main reason for the fragmentation is the lack of economy of scale see below.

The industry is subject to a high degree of regulation [15] even more so than the chemical industry as a whole, particularly if pharmaceutical fine chemical production is involved. The European correspondent is the European Medicines Agency EMEA , which is manly responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. The U. Pharmacopeia [16] codifies quality standards for Active Pharmaceutical Ingredients.

As these standards are observed worldwide, they contribute also to the emergence of a uniform worldwide set-up of the top tier fine chemical companies. Most are not pure players but divisions or b. All have extensive resources in terms of chemists and other specialists, plants, process knowledge, backwards integration, international presence, etc.

The leading companies are typically divisions of large, diversified chemical companies. In terms of geography, 9 of the top 20 are located in Europe, which is recognized as the cradle of the fine chemical industry. This is e. Custom manufacturing prevails in northern Europe; the manufacture of active substances for generics, in southern Europe.

BIOTOL, B C Currell, R C E Dam-Mieras

The second largest geographic area is Asia, housing 7 of the top With 4 large companies, the US rank last. Whereas the European and U. Several large pharmaceutical companies market fine chemicals as subsidiary activity to their production for captive use, e.

Large fine chemical companies, in contrast to mid-sized and small ones, are characterized by. Their portfolios comprise both custom manufacturing and API-for-generics. They include both independents and subsidiaries of major companies.

Biotechnological Innovations in Chemical Synthesis

A number of these companies are privately owned and have grown mainly by reinvesting the profits. Customers prefer to do business with mid-sized companies, because communications are easier —they typically deal directly with the decision maker— and they can better leverage their purchasing power. Most of them are located in Asia. They often specialize in niche technologies. The minimum economical size of a fine chemical company depends on the availability of infrastructure.

If a company is located in an industrial park, where analytical services; utilities, safety, health, and environmental SHE services, and warehousing are readily available, there is practically no lower limit.

New fine chemical plants have come on-stream mostly in Far East countries over the past few years. All big and medium-size fine chemical companies have cGMP-compliant plants that are suitable for the production of pharmaceutical fine chemicals. With the exception of biopharmaceuticals, which are manufactured by only a few selected fine chemical companies, see section 3. This means that they can carry out practically all types of chemical reactions.

They differentiate on the basis of the breadth and quality of the service offering. Contract research organizations CROs provide services to the life science industries along product development. Whereas the production sites of CMOs are multipurpose plants, allowing for the production of tens to hundreds of tons of fine chemicals, the work places of patient CROs are the test persons volunteers for the clinical trials and those of the product CROs are the laboratory benches. Major customers for CRO services are the large global pharmaceutical companies.

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As for CMOs also for CROs, biotech start-up companies with their dichotomy between ambitious drug development programs and limited resources are the second most promising prospects. There are more product CROs. Their tasks are described in Chapter 5, Examples of are:. Contrary to manufacturing companies, invoicing of CROs is not based on unit product price, but on full-time equivalents FTEs , that is, the cost of a scientist working one year on a given customer assignment.

Their history is either a forward integration of a CRO, which adds industrial scale capabilities or backwards integration of a CMO. As there are only limited synergies e. It is questionable, though, whether one-stop shops really fulfil a need. Actually, the large fine chemical companies consider the preparation of samples more as marketing tool and expense The offerings of Patient CROs Clinical CROs comprise more than 30 tasks addressing the clinical part of pharmaceutical development at the interface between drugs, physicians, hospitals, and patients, such as the clinical development and selection of lead new drug compounds.

As clinical trials represent the largest expense in pharmaceutical research, the market for patient CROs is larger than for their product counterparts. The main tasks are 1 designing, respectively duplicating and adapting in case of custom manufacture, and developing laboratory procedures for new products or processes; 2 transferring the processes from the laboratory via pilot plant to the industrial scale the scale up factor from a 10g sample to a 1-ton batch is , ; and 3 to optimize existing processes.

At all times during this course of action it has to be ensured that the four critical constraints, namely, economics, timing, safety, ecology and sustainability are observed. On the business side, product innovation must proceed at a more rapid pace, because life cycles of fine chemicals are shorter than those of commodities. Therefore, there is an ongoing need for substitution of obsolete products.

On the technical side, the higher complexity of the products and the more stringent regulatory requirements absorb more resources. Many economic and technical parameters have been proposed to enable a meaningful assessment of single projects and project portfolios. Most of these parameters cannot be determined quantitatively, at least during the early phases of a project.

The best way to take advantage of a project portfolio is to develop and use it in an iterative way. By comparing the entries at regular intervals, for instance, every 3 months, the directions that the projects take can be visualized. If a negative trend persists with one particular project, the project should be put on the watch list. Provisions have to be made for a periodic examination of all acquired research results to safeguard Intellectual Property Rights IPR and to determine whether patent applications are indicated.

Process Research has to design new synthetic routes and sequences.

Master in Chemical and Biotechnological Process Engineering

Two approaches are feasible. The researcher converts a commercially available starting material and sequentially adds more reagents until the target molecule is synthesized. Key fragments of the target molecule are first identified, then synthesized individually, and finally combined to form the desired molecule through convergent synthesis. Process Development focuses on the design of new, efficient, stable, safe, and scalable synthetic routes to a target fine chemical.

It represents an essential link between process research and commercial production. If the base process is provided by the customer as part of the technology transfer, process, research has to optimize it so that it can be transferred to the bench-scale laboratory or pilot plant. Furthermore, it has to be adapted to the specific characteristics of available production trains. Bench-scale Laboratory , kg-lab and Pilot Plant Development. Particularities of laboratory processes that have to be eliminated include the use of large numbers of unit operations , dilute reaction mixtures, vast quantities of solvents for extraction, evaporation to dryness, drying of solutions with hygroscopic salts.

Although modern reaction calorimeters consent to foresee the effects of these different conditions to a certain extent, a direct transfer of a process from the laboratory to the industrial scale is not recommended, because of the inherent safety, environmental, and economic risks. In development, the viability of the process on a semi commercial scale has to be demonstrated. Trial quantities of the new fine chemical have to be manufactured for market development, clinical tests, and other requirements.

The necessary data have to be generated to enable the engineering department to plan the modifications of the industrial-scale plant and in order to calculate production costs for the expected large-volume requirements. Before the process is ready for transfer to the industrial-scale plant, the following activities have to be completed: Adaptation of the laboratory process to the constraints of a pilot plant, hazard and operability HAZOP analysis, execution of demonstration batches.

The main differences between laboratory synthesis and industrial scale production are shown in Table 4.

In case of cGMP fine chemicals also a process validation is required. It consists of the three elements process design , process qualification and continued process verification. Process Optimization. Once a new chemical process has been introduced successfully on an industrial scale, process optimization is called upon to improve the economics.

The task extends from fine tuning the currently used synthetic method all the way to the search for an entirely different second generation process. Specific provisions are the increase of overall yield, the reduction of the number of steps, raw material cost, solvent, catalyst, enzyme consumption, environmental impact. Ideas for new processes typically originate from researchers, ideas for new products from customers, respectively customer contacts. It has the assignment to evaluate all new product ideas. It decides whether a new product idea should be taken up in research, reassesses a project at regular intervals and, last but not least decides also about the abandonment of a project, once it becomes evident that the objectives cannot be reached.

In a typical project the overall responsibility for the economic and technical success lies with the project champion.


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He is assisted by the project manager , who is responsible for the technical success. In custom manufacturing, a typical project starts with the acceptance of the product idea, which originates mainly from business development, by the new product committee, followed by the preparation of a laboratory process, and ends with the successful completion of demonstration runs on industrial scale and the signature of a multiyear supply contract, respectively.

Depending on the number of researches involved, the total budget easily amounts to several million US dollars. Fine chemicals are used as starting materials for specialty chemicals. Life sciences, primarily pharmaceutical, agrochemical and food and feed industries are the main consumers of fine chemicals.

Biotechnology-a sustainable alternative for chemical industry. - Semantic Scholar

For a number of reasons, such as the lack of statistical data and the somewhat equivocal definition it is not possible to exactly determine the size of the fine chemical market. Furthermore, a distinction is made between captive in-house production and merchant market. Pharmaceutical fine chemicals PFCs account for two-thirds of the total. Within life science products, fine chemicals for agro, and —at a distance— for veterinary drugs follow in importance.

The pharmaceutical industry constitutes the most important customer base for the fine chemical industry see Table 4.