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biosimilar characterization

Critical Factors for Full Characterization of Biosimilars

By EAG | December 8, 2016

Today, about half of all therapeutic drug approvals by the US Food and Drug Administration (FDA) are for biological drugs. That number is expected to rise to 75 percent by 2025. When these biologics come off patent, the gates will open for a flood of biosimilar drugs (biopharmaceutical generics) that are designed to be much…

antibody drug conjugate analysis and characterization

Key Analytical Challenges for Antibody Drug Conjugates

By EAG | December 7, 2016

Currently, there are more than 75 antibody drug conjugates (ADCs) in various stages of pre-clinical and clinical development. The combination of a targeted antibody coupled with a cytotoxic small-molecule drug (via  a flexible linker) makes for a lethal and specific oncologic drug product. However, an ADC is a heterogeneous cocktail of molecules with a range…

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