Commercial Manufacturing at NextPharma Tampere

NextPharma Tampere’s development teams take a sterile ophthalmic or otic product through a defined sequence without handoff to another site: 

• Pre-formulation: API solubility and compatibility, early stability 

• Analytical development: method development and validation, including microbiological methods 

• Formulation: sterile ophthalmic solutions and multidose systems, with or without preservatives 

• Sterilisation strategy: aseptic filling and filterability assessment 

• Clinical supplies: production of clinical batches under GMP 

• Scale-up: process robustness, validation and cleaning verification 

• Industrialisation: registration batches, full validation and ICH stability studies 

For a sterile product, the formulation is only part of what has to be demonstrated: the aseptic filling process, the filterability assessment and — for PFMD — the evidence that the container-closure system maintains sterility across the in-use period all have to hold on the line that will produce commercial batches. At NextPharma Tampere, feasibility work, clinical supply and commercial filling run on the same Annex 1 validated platforms, so the process and analytical methods established during development carry into commercial batches. GMP and non-GMP lab-scale manufacturing, clinical trial supply and pilot-to-production scale-up are all available on site.