Biopharmaceutical Development of the Active Ingredient and Drug Product
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:mRNA, biosimilars and biobetters
IP strategy for non-infringement of processes and compositions
Process development for GMP API manufacture. USP (fermentation) and DSP (protein purification)
Process characterisation in USP and DSP
Definition control strategy, 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, LNP formulations
Modification of the active ingredient molecule (PEGylation, toxin conjugation)
Final dosage forms (single or multidose),
application devices (PFS, pen)
