22 December 2003 00:00 [Source: PCE]
Since its creation in 1973, Sochinaz, a Swiss company based in the Valais area, has been focused on the development and production of active pharmaceutical ingredients (APIs), as well as current good manufacturing practice (cGMP) advanced intermediates and highly potent active ingredients (HPAIs) for the world's leading life science companies.
Sochinaz provides a complete package from the laboratory stage to industrial manufacturing. The company joined the Bachem Group, the leading international producer of peptides, in April 2001, giving Sochinaz access to a broader range of technologies and resources. With a reactor capacity of 70m3, the production facilities have been built to meet the latest GMP design requirements and the majority of the installations have been conceived as multipurpose units. More than 200 tonne of APIs and advanced intermediates are now produced annually. The diverse equipment allows the commercial realisation of a broad range of reactions, including enzymatic and electrochemical reactions. 'All the products are manufactured according to cGMP, production equipment is all qualified, and several individual pieces have a pyrogen-free environment,' says Sochinaz' marketing manager Jean-Marie Rosset
Rosset explains to PCE: 'Quality assurance ensures implementation of cGMP's. Our site is regularly inspected by our customers, by Swissmedic [Swiss Health Authorities] and also by the US Food and Drugs Administration.' Sochinaz is also able to perform complex chemistry under the additional constraints of high containment for handling high-potency materials under cGMPs. HPAI development, manufacturing and process implementation is carried out by trained staff, to safeguard quality. A validation service is available, with preparation of validation protocols, production of validation batches, stability tests according to ICH and registration of European, US and Canadian drug master files.
Rosset adds: 'We have experience with most synthetic organic processes, with particular expertise in chiral synthesis, enzymatic reactions, dipeptide synthesis, electrochemical reactions, amination, Friedel-Craft reactions, Grignard reactions, transamination and acetylation.'
Despite a weak market for APIs, Sochinaz is in expansion phase. The company's sales grew by 25% last year and forecasts growth this year. Last year it produced 260 tonne of APIs and that should grow with investments of SF6m in 2002 and SF7m in 2003.
Rosset said this investment phase will continue into 2004, with a new plant due onstream by the end of the year, including a 6m3 high-pressure reactor. The company has 85 staff and its main business areas are custom synthesis, generics and amino acid chemistry. It says that 10% of its output is HPAIs across both its custom synthesis and generics activities.
When he reported on Sochinaz' parent company Bachem's first-half results, chief executive Rolf Nyfeler said the sluggish economy has led to less spending on research with a sales decline in the research chemicals business. By contrast, the active ingredient business developed in a positive way. In new chemical entities, APIs that are patented and may only be manufactured or used by the patent holder or by companies authorised to do so by the patent holder, two trends played a role in sales development.
On the one side, the pharmaceuticals sector, the most important customer segment for Bachem, did not show the dynamic growth of previous years. On the other side, companies in the biotech industry, the second most important market for Bachem, found it increasingly difficult to raise funds, leading to a slowdown in development for new medicines. The generics business, the manufacture of APIs whose patents have expired, showed a positive development. Both the generic peptides produced by Bachem and the non-peptidic generics from Sochinaz showed good growth.
The US market, the weakness of the dollar and delays in the completion of projects had an impact on the consolidated Group result. Business in Europe by contrast profited from a lively demand for generics. Investments just short of SF5m were in keeping with anticipated activities. In view of the continuing high utilisation of capacity in the Group, further projects are being examined.
Particular emphasis here is on Sochinaz, for which an expansion of production capacity is under way due to the increase in demand for generics.
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