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Drug Substance Overview

Catalent Biologics’ drug substance development and manufacturing services leverage advanced technology and proven expertise to help clients meet their biologics drug substance needs. Our development teams collaborate closely with our bioanalytical testing and manufacturing teams to ensure that processes and products are scalable to clinical and commercial scale.

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.