Definition of an individual process strategy (expression, fermentation, purification, modification- PEGylation or conjugation)
to fit the desired Target Product Profile (TPP)
Regulatory support for CMCstrategy - Specialfields:biosimilars and biobetters
IP strategy for non-infringement of processes
Process development for GMP API manufacture. USP (fermentation) and DSP (protein purification)
Process characterisation in USP and DSP
Definition CQAs, CPPs, Design Space (ICH Guideline Q8)
Planning of representative studies with scale down models
Risk assessment
Process validation USP and DSP
Drug Product development
Galenicdevelopment – liquid protein
formulations
Modification of the active ingredient molecule (PEGylation, toxin conjugation)
Final dosage forms, application devices (PFS,
pen)
