Global custom synthesis specialist Saltigo GmbH will present its extensive portfolio of services at the upcoming CPhI Worldwide (the international trade fair for pharmaceutical ingredients) in Paris from October 5-7, 2010. The focus will be on exclusive organochemical syntheses for the entire life cycle of active pharmaceutical ingredients. "Custom manufacturing is our core business. We are represented all over the world and we constantly invest in new technologies," says Dr. Andreas Stolle, head of the Pharma business line at Saltigo, describing the key factors for the company's success. In addition, sustainable process improvements accompanied by cost reductions in all areas of product life cycle management give Saltigo's customers added value.
For Stolle, small steps can also lead to success. "It is not always necessary to directly build a new production plant. Manufacturing processes can be up-graded with only a small investment to significantly improve their economic efficiency. Provided, of course, that you have the relevant know-how," adds the chemist. For example, the productivity of a process used for the production of a precursor of an active ingredient was considerably increased by incorporating a separator. Through this simple change, it was possible for the first time to efficiently separate inorganic by-products. As a result, the duration of the campaign was halved.
To be well-equipped to meet the mounting demand for active pharmaceutical ingredients with increased potency, Saltigo is considering setting up capacities for "potent APIs" in Leverkusen, Germany, and Redmond, United States. According to Stolle, this, too, requires only minor investment. The company would then be in a position, in the short term, to produce active ingredients with an OEL (Occupational Exposure Limit) of less than 10 micrograms per cubic meter.
The company is also at the cutting edge of technology when it comes to "Challenging Chemistry". Handling such demanding chemical reactions is one of Saltigo's core competencies. "We opt for Challenging Chemistry in order to manufacture products in high purity and with a high yield, and also to avoid the generation of waste and lower production costs," says Stolle. Internal cooperation with LANXESS’ Innovation group function in the field of microreactor technology is extending Saltigo's possibilities even further. "The traditional concept of producing active ingredients in stirred-tank reactors will need to be revised in future. More and more continuous reactions are now being considered in active ingredient synthesis, and in some cases they are already being successfully carried out," says Stolle. Microreactors are used in the chemical industry for the miniaturization of technical processes: the required reactor volume decreases while the capacity remains the same. The mixing times correspond to the time it takes to blink an eye. The technology enables the use and monitoring of chemical reactions that could previously not be controlled.
To extend its service offering, Saltigo also cooperates with technology experts such as those from Reuter Chemische Apparatebau KG (RCA) based in Freiburg, Germany. In the field of separation technology for the production of chiral, enantiomerically pure substances, Saltigo has been working for many years with this company, on the development of processes for the synthesis of active pharmaceutical ingredients and intermediates. RCA produces high-grade chiral substances, and also has innovative, patented technologies for racemate separation. With Saltigo's experience in working with complex molecules and Challenging Chemistry and RCA's know-how in the field of chiral separation, economical separation processes for a given racemate can be identified. The process can then be scaled up quickly and efficiently from laboratory to production scale. For an active ingredient in Phase III clinical testing, for example, RCA produces the starting material, which Saltigo uses to manufacture the subsequent steps to generate the active ingredient.
In addition to the actual technical implementation, quality control and quality management also play a key role in the pharmaceutical industry. Saltigo's production plants recently passed an audit by the U.S. Food and Drug Administration (FDA) with a "No findings" rating. Saltigo's Managing Director Wolfgang Schmitz is delighted that the official auditors did not have any objections: "The FDA audit is an internationally accredited seal of quality and recognizes all the work we have put in. This shows not just U.S. customers but also pharmaceutical companies throughout the world that with us the production of active ingredients is in safe and reliable hands."
Saltigo GmbH (saltigo.com) is a leading supplier in the field of custom synthesis. The company of specialty chemicals group LANXESS belongs to the Advanced Intermediates segment, which achieved total sales in 2009 of EUR 1,104 million. Saltigo, headquartered in Langenfeld and with production facilities in Leverkusen and Dormagen, employs around 1,400 staff worldwide. LANXESS Corporation (lanxess.com) operates a site for Saltigo in Redmond (Washington, United States).