BASF boosts spray-drying capacity with GEA Niro alliance
pharmafile | February 17, 2010 | News story | Manufacturing and Production |Â Â BASF, spray-dryingÂ
The custom synthesis division of chemicals giant BASF has joined forces with processing equipment specialist GEA Niro to broaden its capabilities in the production of active pharmaceutical ingredients.
Under the terms of the deal, BASF’s Pharma Ingredients & Services business unit will be able to carry out spray drying tests and pilot productions of APIs at GEA Niro’s Pharma Test Station in Copenhagen, Denmark, which is reportedly the only facility of its type in the world.
Spray-drying techniques have been used for decades in the food and chemical industries but are increasingly popular in pharmaceutical manufacturing as an alternative to conventional freeze-drying because of the tight control the process can achieve over the size of API particles.
This in turn has a critical effect on the API’s bioavailability and overall performance of formulations. Spray drying is particularly suited to poorly-soluble APIs, which account for roughly 90% of all new drugs in development.
Drugmakers are increasingly demanding that this factor is rigidly controlled, batch after batch, in the production of APIs, and contract manufacturers have been installing the necessary equipment to make them.
And while other technologies exist for particle size and morphology control, spray drying is becoming more widely used, largely because of its scaling-up capabilities, which allow production volumes to go from grams to tonnes yet still provide particles with the same size and morphology.
Spray-drying has additional benefits, in that it can be used to create API particles alongside polymers and other excipients that provide specific controlled-release characteristics, taste-masking and protection of fragile APIs.
BASF says that by combining its custom synthesis capabilities and expertise in excipients with GEA Niro’s spray drying know-how, it has created a “unique value proposition” for its pharmaceutical customers.
Folker Ruchatz, director of global business management custom synthesis at BASF, said: “with this cooperation we add to our portfolio the ability to offer a cGMP facility” for pilot production.
The Pharma Test Station offers over 40 different pilot plants for feasibility and pilot-scale testing of various spray-drying various processes and is used to refine products and processes as well as to produce material for safety, stability and toxicology studies and clinical trials.
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