Held April 18–22 in Lake Buena Vista, Florida, WRIB 2016 was well attended this year, with about 700 attendees. This 10th Workshop on Recent Issues in Bioanalysis, where regulators and professionals representing pharma/biopharma, biotech, CRO organizations gather to discuss challenges in method development and emerging approaches, proved as fruitful as years past.
Here are a few high-level takeaways from the main talks:
- It’s about the and, not the or: Both ligand binding assays (LBAs) and analysis by chromatography and mass spectrometry (LC-MS) are essential for bioanalysts. One speaker from a top ten pharmaceutical company stated, “Stop with the ‘either/or’ regarding LBAs and LC-MS. You need both.”
- LC-MS has earned its place: LC-MS was described as “a must for bioanalysts” and “no longer an emerging technology for the bioanalysis of biotherapeutics and biomarkers.”
- Emergence of High Resolution MS: The expanding role of HRMS for targeted quantification and application in a regulated environment was a recurring theme. Dr. Chris Evans from GSK presented data about how QTof technology enabled sensitivity (to 1 pg/mL in matrix) through enhanced selectivity (read the details of how Dr. Evans accomplished a validated, sensitive and robust assay with Tof-HRMS).
- The next challenge: ADAs (anti-drug antibodies) are causing issues for bioanalysts was a hot topic.
- Smaller is better: Microflow applications were touted as a viable option for high-sensitivity needs. Waters’ ionKey/MS System was recognized by one large pharmaceutical company for its increased sensitivity, lower sample volumes, solvent consumption, ease-of-use, and standardization.
Like the talks, the poster sessions included a variety of bioanalysis techniques and were well attended. There was particularly high engagement near the four Waters protein quantification posters.
With a diversity of options for protein quantification, numerous questions arise regarding the advantages of each approach. Can intact mAbs be quantified using LC-MS? Is reduction and alkylation always needed for a surrogate peptide approach? Are there advantages to using a kit when performing the surrogate peptide method? Does a bottom-up or top-down approach produce higher sensitivity? Download the posters below to address these questions and many others.
Waters presented five posters in total:
- Systematic Method Development for Quantification of Proteins via the Surrogate Peptide Approach Using LC-MS/MS, MassLynx, and Skyline
- Development of a Generic Kit-Based Approach for Quantifying Protein Therapeutics in Biological Matrices by LC-MS/MS
- Quantification of Intact Protein Biotherapeutics by a Microfluidic LC-MS Platform
- Rapid, Simplified and Highly Efficient Analysis of Urinary THC and Metabolites Using a Novel Reversed-Phase Extraction Sorbent
- Utilizing the LC-MS Tool Box in Protein Bioanalysis
The next conference on the travel schedule is ASMS in San Antonio, Texas. Waters is hosting a number of concurrent events including a users meeting, breakfast seminars, oral and poster presentations, and a hospitality suite. Up-to-date information can be found at our Waters ASMS website. Hope to see you there!
For additional information on Waters bioanalysis applications, please visit http://dmpk.waters.com/.