Chemist US Food and Drug Administration Silver Spring, Maryland
The presentation will start with an overview of the FDA M10 BMV guidance, and ICH Q2R2 and Q14 guidelines. Subsequently, the presentation will discuss the implementation of hybrid LBA LC-MS for ADC, mAb, transition product and peptide conjugates to highlight FDA’s regulatory experience. Finally, the presentation will use three case studies to elaborate how the workflow was collectively governed by the molecule, indication and route of administration. Moreover, risk assessment for each of case studies will be performed to visualize how assay performance was assured during method implementation. Important for this process, the assessment of method robustness will be discussed with case study 1, in which hybrid assay supported large-scale, long-running clinical trials. • Case study 1: Combinational antibody therapy approved under EUA. • Case study 2: A transition product approved under BLA. • Case study 3: A peptide conjugate for two different indication and routes of administration approved under NDA. In summary, the presentation will highlight new technologies (e.g., high resolution mass spectrometry and turbo flow extraction), a new biological matrix (e.g., nasal lining fluid) and new therapeutic modalities (e.g., oligonucleotides, DARPin, and antibody-peptide conjugates) reflected in recent submissions and scientific publications.
Learning Objectives:
Participants will better understand how the recommendations in FDA M10 Bioanalytical Method Validation and Study Sample Analysis Guidance and ICHQ2(R2) Validation of Analytical Procedure Guideline (draft) will strengthen data quality.
Participants will understand the importance of good practices in the systematic and rigorous implementation of BMV guidance, especially when adopting new technologies and implementing new technologies for new applications.
Participants will be able to identify and access evolving or innovative practices in LC-MS based bioanalysis for biotherapeutics which can assure the quality of bioanalytical data to support regulatory decision.
