The pharmaceutical industry is moving towards a profitability gap between increasing costs and decreasing prices. Finally, management has understood that mergers and acquisitions, high throughput screening, and biotechnology alone will not save the companies' earnings. Therefore, classical approaches like the optimization of production technologies for drug substances, that might help to increase profitability, are receiving increasing attention. This paper shows how the combination of innovative components will guide the way to very efficient and cost-effective production. The first component is the design and manufacturing of production facilities. The second component is a process streamlining of the production process. The key technologies discussed here are process control and miniplant technology. For these technologies a brief outlook on future trends is given.
The synthesis of valuable ethers, carboxylic acids and alcohols has been achieved by telomerization and hydrogenation procedures using only butadiene, carbon dioxide, ethylene glycol and hydrogen as starting materials. High product selectivities and yields have been realized in all reaction steps and catalyst recycling has been achieved by liquid-liquid-two-phase techniques. This way, ecologically and economically favorable chemical syntheses have been demonstrated using the waste gas carbon dioxide and other cheap feedstocks. † This work was presented at the Green Solvents for Catalysis Meeting held in Bruchsal, Germany 13-16th October 2002.
The homogeneously catalyzed reduction of carboxylic acids with hydrogen was studied. Bimetallic catalysts consisting of a group 8 or 9 late transition‐metal and a second group 6 or 7 transition‐metal carbonyl showed a synergistic effect allowing the conversion in good yields under moderate conditions. Besides the effect of different catalyst precursors, the influence of temperature, hydrogen pressure, and catalyst concentration was investigated. An equimolar mixture of [Rh(acac)(CO)2] and [Mo(CO)6] showed the highest activity and was therefore applied to the reduction of lactones to diols. The reduction potential of the catalyst was found to be dependent on the ring size of the lactone used. Five‐membered ring lactones were hardly converted to diols whereas six‐ and seven‐ membered ring lactones reacted easily.
Die Pharmaindustrie befindet sich auf dem Weg in die Kostenfalle. Mehr und mehr setzt sich die Erkenntnis durch, dass klassische Stärken der Optimierung von Produktionstechnologien dort ansetzen können, wo Fusionen, Investitionen in High‐Through‐Put‐Screening und Biotechnologie bisher nicht die nötigen Erfolge gezeigt haben. Im vorliegenden Beitrag wird gezeigt, wie aus einer Kombination von innovativen Bausteinen eine leistungsfähige und deutlich kostengünstigere Produktion von Pharmawirkstoffen resultiert. Diese kann den Ausweg aus der Kostenfalle weisen. Ein erster Baustein, der betrachtet werden soll, ist der Anlagenbau, daneben ist eine deutlich stärkere Prozessorientierung als zweiter Baustein zu sehen. Die Technologien, die den dritten Baustein der neuen Produktionswege für Pharmawirkstoffe darstellen, sind die Miniplant‐Technologie und die Prozessanalytik. Zu letzterem technologischen Baustein werden anhand von Beispielen die Trends der Zukunft aufgezeigt.
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