Partnering with CrOs tO DevelOP high-Quality aDCs Key Bioanalytical Strategies aDCs are a breakthrOugh CanCer treatment that Can Deliver CytOtOxins DireCtly tO CanCer Cells withOut the sweePing COllateral Damage Of traDitiOnal ChemOtheraPy
نویسنده
چکیده
Antibody drug conjugates (ADCs) have grown extremely popular in the pharma industry with 238 clinical trials testing 47 unique ADCs in 20141, but these are complex molecules that need careful development of a bioanalytical strategy to inform the clinical team as to the exposure, safety, and risk profiles of the dosed molecule. This article will highlight some of the key bioanalytical strategies used to support ADC programs, the critical challenges associated with this development and subsequent validations, and hurdles that biopharma companies and CROs may neglect to consider.
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تاریخ انتشار 2015