Nanoplex integrates an array of advanced analytical characterisation tools for investigating the physical, chemical and mechanical properties of primary and secondary processed APIs and excipients. This integrated approach enables identification of the critical material attributes of a particular dosage form.
Nanoplex is a quality by design based approach for identifying critical material attributes that effect drug product critical quality attributes. This material science based suite of services supports CMC development through all phases of pharmaceutical drug product development.
Nanoplex has successfully been utilised in understanding physico-chemical stability of micronized APIs and has provided direct guidance in API process development. Increasingly, Nanoplex is been utilised to understand and control critical material attributes that directly affect the in vitro and in vivo performance of a range of pharmaceutical dosage forms.