WRIB (Workshop for Recent Issues in Bioanalysis) is an annual gathering of bioanalytical scientists from across the pharmaceutical industry spectrum. Attendees include big pharma and biopharmas, biotechs, CROs and multiple regulatory agencies working on both small and large molecule bioanalysis.
Ashley Brant and Dr. Neal Simmons represented AIT Bioscience (AITB) discussing LC-MS/MS assays, and Franklin Spriggs also represented AITB covering Ligand Binding Assays. AIT Bioscience showcased its scientific prowess by garnering the Top LC-MS/MS Small Molecule Poster Award for our case study on chiral assay development and validation via diastereomer derivatization titled: Chiral Derivatization of D- and L-Eflornithine for Enantiomer Identification from a Racemate and Chromatographic Separation
AITB also garnered an honorable mention for its poster titled: Electronic Laboratory Notebook as a tool to Facilitate Scientific Data Analysis and Review in Regulated and Non-Regulated Bioanalysis
The event fosters open collaborative discussions to address both scientific and regulatory issues facing the industry.
Regulatory issues included:
- Pending draft guidance from US FDA on Bioanalytical Method Validation (BMV) and Immunogenicity Assessment
- Discussion of recent agency findings and their impact on current industry practices
- Panel discussions with regulatory agency members where interpretation of the draft and current guidance can be openly addressed
- Clarification of procedural expectations when conducting stability assessments ICH (International Conference on Harmonization) announcement of their pending guidance document on bioanalytical method validation by 2019
Scientific issues included:
- Fit-for-purpose approach to validations and when this approach should be applied. New techniques to overcome the challenges in developing bioanalytical assays for peptides
- The use of cutting edge approaches for protein biotherapeutics quantitation by LC-MS/MS in a regulated environment
- Fit-for-purpose approach specific to biomarker assays
- The impact of ex-vivo and matrix sample collection factors on biomarker values
- The possibility of avoiding cell based neutralizing antibody assays by using appropriate biomarkers
- Challenges in conducting domain specificity to characterize anti-drug antibody response to multi-domain protein therapeutics and combination biotherapeutics
Did you miss WRIB? Download our experts full summary of the event.
In addition to WRIB, the AITB team has been busy attending the Society for Toxicologists National meeting, the AAPS-National Biotech Conference, the Maryland Tech Council Bio+Tech conference and the regional AAPS-Northeast Regional Discussion group.
Want to learn more about any of these meetings? Contact us today to discuss how the issues raised may impact your bioanalytical studies!