MVIC can now, through our member company Magle Chemoswed, offer GMP Solid State services. The Solid State laboratory of Magle Chemoswed, has implemented cGMP services within the following selected areas critical for inhalation product development:
- Determination of amorphous content by microcalorimetry. “Our methodology and related performance are comparably unique, and we especially welcome customers to contact us in this particular area”, says Thomas Larsson, Solid State Manager at Magle Chemoswed.
- Determination of particle size distribution by laser diffraction.
- Identification of API crystal modification and quantification of undesired polymorphs by X-ray powder diffraction.
In all cases, method development and validation are included.
As a result from an inspection by Swedish MPA, our Solid State laboratory will be provided with a GMP certificate at latest in mid-July this year. This certificate will also cover US/FDA, based on an agreement between the two agencies. Please, contact MVIC (lars.asking@mvic.se) if you would like to know more about this service.
“Our Solid State laboratory has provided R&D Solid State services to inhalation product development companies since 2012 (in the beginning as “Adroit Science AB”) and our services are highly recognised, continuously receiving positive feedback. The aim is now to establish the same reliable interaction and customer satisfaction within GMP service area”, says Thomas Larsson.