GMP spray drying facility gains approval for commercial production of human medicinal products

GEA Process Engineering’s pharmaceutical GMP spray drying facility in Copenhagen, Denmark, has been granted authorisation by the Danish Health and Medicines Authority for spray drying of human medicinal products for commercial use. The company’s license now covers spray drying of products for both clinical trials and commercial use.

With the new authorisation in place, GEA is able to provide services to companies working with the development of spray dried pharmaceuticals through all phases of their development cycle. Since 2004, when the facility was authorised for spray drying of investigational medicinal products, GEA has provided spray drying process development and contract spray drying to pharmaceutical companies and CROs.

“Having the authorisation for spray drying for commercial use closes a gap in the services we provide to our customers,” said Tonny Christensen, head of GEA’s pharmaceutical spray drying team in Denmark. ‘With our expertise within spray drying process development and now the authorisation to make batches for both clinical trials and commercial products, we are a good match for CROs and others who need a partner for this. Not only will our customers benefit from having only to team up with one partner — with all the benefits involved in terms of setting up confidentiality and cooperation agreements, tech transfers, etc. — they will also benefit from our vast expertise within spray drying throughout their development project.”

GEA Process Engineering, the company behind GEA Niro spray drying technology, is claimed to be the only company supplying both spray dryers and GMP spray drying services to the pharmaceutical industry.

GEA Process Engineering A/S, www.gea.com.