Process changes
GlycoThera offers drug substance and drug product comparability programs during the development of biopharmaceutical proteins.
These programs are mandantory to demonstrate comparability after
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process changes / optimizations
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scale-up
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production site changes
The demonstration of equivalence to materials used in toxicology and early / late phase clinical trials is indispensable.
Comparability exercise for biosimilars
Furthermore, comparability studies comparing the biosimilar and its reference market product represent a central task in the preparation of submission dossiers of biosimilars for marketing authorization.Experience
GlycoThera has performed analytical comparability studies for many clients and different products, and GlycoThera's reports have set standards for market authorization dossiers submitted to regulatory authorities.
