Drug Development

Service Overview Drug Development and Manufacturing

• Development of solid, semi-solid and liquid formulations for oral, topical, nasal and parenteral application
  
• API characterisation and quality screening
• Small batch manufacturing §Clinical trial batch manufacturing and distribution
• Analytical method development and validation 
• Stability testing according to ICH
• Primary and secondary packaging
• Serialisation

• Handling of potent and high-potent APIs
• Small scale and CTM manufacturing
• Dosage forms: Tablets, coated tablets, mini-tablets, Hard capsules, Granules, pellets, powders, Matrix tablets for modified / sustained release
• Specialities: Nanoparticulate API (via wet grinding), Microprecipitated Bulk Powder (MBP)

• For oral, topical and intranasal application
• Small molecules, peptides and proteins
• Batch sizes of up to 100 kg
• Dosage forms: Solutions, Suspensions (micro/nano), Emulsions, Oleo- and hydrogels, Lyophilisates,
• Filling in vials, bottles, syringes, nasal application devices

• Compatibility studies
• Development, verification and validation of analytical testing methods
• Development of cleaning methods and verification
• Stability studies under ICH conditions incl. stability storage
• Freeze-thaw-cycle, forced degradation and photostability studies