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Emerging Trends in Single-Use Technology in the Manufacturing of Antibody-Drug Conjugates

Emerging Trends in Single-Use Technology in the Manufacturing of  Antibody-Drug Conjugates +

Single-use technology, designed for the manufacturing of biopharmaceutical products, has made major inroads over the last 30 years. First introduced in the late 1970s in the form of disposable capsules and a range of filters, single-use technologies were revolutionized in the late 2000s with the introduction of single-use 2D and 3D process containers and filter assemblies for mixing and storage systems. Today, these technologies have been adopted across the upstream manufacturing process, downstream purification and fill-finish of entire classes of biologic drugs. Article by: Karen Green MBA, Mary Robinette PMP, Gang Yao Ph.D and Nicholas Landry MBA

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Evolution of Antibody-Drug Manufacturing

Evolution of Antibody-Drug Manufacturing +

Antibody-drug Conjugates (ADCs) have evolved since the initial approval of gemtuzumab ozogamicin (Mylotarg®) in 2000, with respect to conjugation, linker and toxin chemistries and processing. With the current availability of 4 commercially approved drugs and approximately 80 programs in various clinical trials, there has been a significant interest in simplifying the complex supply chain.

With approximately 80% of the programs outsourced to Contract Development and Manufacturing Organizations (CDMOs), a transparent and integrated supply chain is critical for the success of ADC projects.

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