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From First-in-Human to Post-Commercial: ADC Reference Materials and Specifications

The 2019 World ADC conference in San Diego, CA, held October 8 – 11, 2019, started with a day of 9 interactive workshops on...

Antibody Drug Conjugate Development: Keys to Rapid IND Submission and Approval

Antibody drug conjugates (ADCs) are a relatively new type of drug that combines the targeting ability of a biologic with a highly potent cytotoxic...

Evolving CMC Analytical Techniques for Biopharmaceuticals

1.0 Abstract During the (early) preclinical drug development process as well as manufacturing of biopharmaceutical (protein) products, analysis and characterization are crucial in gaining a...