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Lines of work

Lines of work

Main activities in the field inhalation technology:

Basic development

  • Feasibility studies including formulation and short term stability studies, which can vary in length from 3-12 months
  • Analytical method development and validation according to ICH guidelines
  • Development of new analytical techniques and more sensitive and efficient test methods e.g. using High Pressure Liquid Chromatography (HPLC), High Pressure Liquid Chromatography combined with Mass Spectroscopy (HPLC-MS), Rapid Resolution High Pressure Liquid Chromatography (RR-HPLC®)/Ultra Performance Liquid Chromatography (UPLC®), Gas Chromatography (GC), Gas Chromatography combined with Mass Spectroscopy (GC-MS), Laser diffraction measurement etc.
  • Development of new formulation processes and techniques

Pharmaceutical development

  • Clinical trial supply: Manufacture and testing of investigational medicinal products in compliance with European Union and the United States requirements according to Good Manufacturing Practice (GMP) standards
  • ICH-Stability Studies, in-use studies, characterisation studies, stress and robustness tests of excipients, drugs substances and formulations
  • Process robustness and validation
  • Pilot scale manufacture, scale -up and transfer to production and quality control

Device development

  • Device design and construction with state of the art techniques including 3D computer aided design software.
  • Industrial scale-up support (engineering expertise, innovations/inventions)
  • Device testing
  • Development of test equipment and methods for functional device testing
  • Device characterisation studies e.g. aerodynamic performance tests, testing of mechanical robustness (drop test, vibration, transport), photo stability etc.

Analytical development

  • Leachables & extractables testing acc. to PQRI requirements
  • Development of foreign particulate methods and corresponding in-house analyses
  • Aerodynamic analytics for characterisation of inhaled products e.g. using impactor techniques (Andersen Cascade Impactor, Next Generation Impactor, Abbreviated Impactor Measurement etc.)
  • Automation of test methods for device and product testing e.g. automated particle characterisation and automated waste dosing
  • Development, implementation, and maintenance of special test equipment e.g. inhalation test systems

Maintain GMP status

To ensure safety, quality and efficacy of our products

  • Documentation for product approval
  • Investigational New Drug Applications (IND), Investigational Medicinal Product Dossiers (IMPD), Marketing Authorisation Application (MAA),New Drug Applications (NDA) and Drug Master Files (DMF), general CMC documentation.