GlycoThera's quality policy supports biopharmaceutical drugmakers during the entire life cycle of their products and for all types of biopharmaceutical products (biosimilars, follow-on biologics, biobetters and innovative products).
GlycoThera helps its clients through the early stages of development of their products (incl. cell clone selection) offering further assistance up to and including scale-up to commercial manufacturing scale. Since years, GlycoThera is engaged into comparability studies and other relevant studies (e.g. stability testing) for marketing authorisation application of its clients, often also being involved into release testing of drug substance and/or drug product.
GlycoThera guarantees high quality and regulatory compliance of its analytical services during all stages of biopharmaceutical development up to and including market release testing.
GlycoThera has set the highest quality standards for marketing authorization application submissions of biosimilar biopharmaceuticals since 2004.