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2006-09-26 News Release

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Achieving CGMP for pharmaceutical intermediates

A leading service provider of custom manufacturing, emphasizes its commitment to exclusive synthesis of innovative pharmaceutical intermediates and active ingredients.

By achieving CGMP (Current Good Manufacturing Practice) status for a high-pressure hydrogenation production facility, Saltigo GmbH, a leading service provider for custom synthesis and custom manufacturing, is once again emphasizing its commitment to exclusive synthesis of innovative pharmaceutical intermediates and active ingredients. To this end, the wholly owned subsidiary of the LANXESS chemicals group offers its customers throughout the world market-focused and customer-oriented complete solutions for the development, piloting and production of active ingredients and intermediates.

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The production unit, which has an annual capacity of 500 metric tons, achieved CGMP status in record time. The whole process, from the planning of the project to the first customer audit and finally to the start of production for the first CGMP product in September 2006, took only nine months. The main component of the ISO 9001- and ISO 14001-certified facility is a 5 cubic meter reactor made of Hastelloy HC4 that is designed to function at reaction pressures of up to 250 bar and reaction temperatures of up to 230 °C.

Saltigo a custom manufacturer to the pharmaceutical industry. photo: Saltigo

“The plant enables us to carry out practically any typical hydrogenation reaction and a wide range of special reactions,” comments Dr. Claus Dreisbach, hydrogenation plant manager at Saltigo. These reactions range from hydrogenation of aromatic nitro compounds and nuclear hydrogenation of aromatics to reduction of aldehydes, ketones, imines, nitriles and compounds with carbon-carbon multiple bonds, and reductive aminations and alkylations. An extremely wide range of catalysts can be used for these applications. Typical heterogeneous catalysts (e.g. Raney metals or carrier-fixed platinum metals) can be used, as can homogeneous catalysts, for example combinations of ruthenium compounds and chiral bisphosphane ligands for homogeneous enantioselective hydrogenation.

Saltigo’s extensive expertise in high-pressure hydrogenation on a production scale is further enhanced by the synthetic opportunities that the ZeTO* (Central Organics Pilot Plant) offers specifically for piloting and production under CGMP conditions. There is also the capacity for small-scale high-pressure hydrogenation in liter volumes.

Furthermore, Saltigo operates cutting-edge facilities for the parallel and automated optimization of hydrogenation reactions, thus facilitating rapid and efficient process development. For example, a parallel hydrogenation plant developed by the company can be used to carry out six reactions in milliliter volumes simultaneously at up to 300 bar and 300 °C. ZeTO™ also has upscaling autoclaves with a capacity of 250 liters that are designed for operating conditions up to a maximum of 200 bar and 200 °C. In addition, upscaling can be carried out under CGMP conditions, if required.

Alongside a diverse range of basic CGMP technologies and the above-mentioned high-pressure hydrogenation under CGMP conditions, Saltigo also offers customers special reactions in regulated areas of application (e.g. phosgenations and fluorinations) and the ability to handle reagents with a high energy content and highly exothermic reactions safely and reliably. This technology portfolio enables Saltigo to rapidly develop cutting-edge solutions to meet the demands of customers in the pharmaceutical industry.

* ZeTO is a registered trademark of Saltigo.

Please visit Saltigo at CPhI 2006, October 3-5, 2006, Paris, stand no. 5H06.

Find Information about Lanxess AG.

Read a recent press release about - Chemicals group, LANXESS, raises prices for trimethylolpropane in Europe due to drastic increases for raw material, energy and logistics costs.

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