Drug Substance Overview
Catalent’s cell line development technology, GPEx®, produces high-performance, highly stable, production cell lines in a wide variety of mammalian host cells. Whether you utilize our cell line development technology or develop your cell lines in house, our process development can develop a process leveraging fed-batch or process intensification technologies (such as N-1 perfusion) and ensure consistent CGMP manufacturing performance and a reliable product supply.
Catalent’s expertise in biosimilar development and manufacturing can accelerate your biosimilar development using a comprehensive suite of analytical capabilities and proven GPEx® technology. Finally, our antibody drug conjugate (ADC) and bioconjugation technology, SMARTag®, enables site-specific, controlled drug-protein conjugations and uses only naturally occurring modifications to proteins requiring minimal cell-line engineering.
Catalent Biologics’ drug substance manufacturing services provide flexibility and scale to support your growth. Catalent’s two state-of-the-art facilities utilize either single-use or stainless-steel bioreactors in a rigorous CGMP environment.