Challenges and opportunities for bioanalytical support of new drug modalities

New drug modalities continue to accelerate beyond therapeutic proteins and into cellular and molecular medicines, resulting in the introduction of new bioanalytical methods to support their advancement. Flow cytometry, polymerase chain reaction, ELISpot, neutralizing antibodies for AAV and other viral vectors, and the promise for precision medicine/cures for some of the most challenging diseases have resulted in the introduction of a variety of technologies to stretch the boundaries of current pharmacokinetic and immunogenicity assessments.