Sigma-Aldrich further expands its cGMP contract development and manufacturing facilities to the pharmaceutical and biotech industries
Sigma-Aldrich has expanded its contract development and manufacturing for active pharmaceutical ingredients (APIs) at its Buchs cGMP certified production site in Switzerland.
The newly opened cGMP kilo lab has been designed for the production of gram-to-several kilogram quantities of APIs and key intermediates for preclinical phase to phase II clinical studies, and further expands Sigma-Aldrich's contract development and manufacturing services to the pharmaceutical industry.
The new kilo lab is based on simulated moving bed (SMB) separation technology and has been designed to address drawbacks of scale-up from benchtop to production that can lead to loss of time and money during the development of a new drug.
As a development or manufacturing partner, Sigma-Aldrich's SMB technology helps biotech and pharmaceutical companies to overcome the problems associated with separation techniques, such as preparative-scale, high-performance liquid chromatography (HPLC).
"The scale-up of active pharmaceutical ingredients (APIs) from the discovery stage to the production stage invariably involves complex chemistry or route redesign," comments Andreas Weiler, business manager europe, organic custom synthesis.
"A successful lab procedure rarely operates cost-efficiently on a large scale.
"However, if costly development is optimised in early-stage clinical trials, a project is likely to be more economic in the long run, and have a greater chance of success".
The Knauer SMB unit together with a new Bruker Esquire 3000plus ion-trap mass spec (with ESI, APCI, APPI, and Maldi as ion source) and Agilent 1100 HPLC system (with additional DAD and fluorescence detection) is faster and more efficient, thus reducing development costs.
The installation allows up to a 25 litre scale in four segregated walk-in fume hoods.
The use of dedicated glassware allows safe and fast cGMP production and flexibility due to interchangeable parts and custom design, which is usually not possible in multi-purpose production equipment.
The new kilo lab in Buchs complements the existing fully-segregated cGMP kilo lab facilities in Sigma-Aldrich's Gillingham facility in Dorset, UK.
The Dorset facility was successfully audited by the FDA in June 2002 and provides the capability to support drug development from discovery, through clinical phases, to commercial launch for low-volume APIs.
