This group focuses on issues pertaining to the bioanalysis of biological molecules and develops best practices/methods for pharmacokinetic (PK), immunogenicity, and biomarker assays in order to address questions related to drug development. The group’s scientific remit is directed at the analytical methods, assays, technologies, and how they are developed, qualified or validated, and utilized. The methods primarily involve ligand binding assays which typically include immunoassays, flow cytometry, activity, and cell-based assays. Additional assay technologies and formats routinely employed include, but are not limited to polymerase chain reaction based assays, emerging technologies such genomic technologies, and immunocapture liquid chromatography/mass spectrometry that may or may not utilize the principal of ligand binding as a key component for measurement. The analytes measured include proteins, antibodies, deoxyribonucleic acid/ribonucleic acid, and other macromolecules. Relevant small molecules, such as those conjugated to antibodies, may also be measured.
- Discuss issues that impact the development, validation, and bioanalysis of PK, immunogenicity, and biomarker assays for traditional and novel therapeutics.
- Engage pharmaceutical scientists and regulators to develop best practices/recommendations that are fit-for-purpose, and comment on regulatory developments and new draft guidance documents.
- Examine emerging technologies and automation used in the bioanalysis of biological molecules, and incorporate them into robust assay formats as suitable for drug development.
- Educate and inform the bioanalytical community through newsletters, white papers, webinars, and AAPS programming.
- Collaborate and work with other AAPS focus groups to achieve cross-functional goals.
The group's mission is to provide a forum to educate and promote best practices for the development, validation, and bioanalysis of macromolecules via ligand binding assays and related analytical methodologies used for assessment of PK, immunogenicity, and biomarkers, as applicable, for therapeutic drug development and patient stratification to enable personalized treatment.
Section affiliations: APQ | BIOTEC