The Excitement and Frustration of ADCs
Bioanalysis of Antibody Drug Conjugates in the Spotlight
Few, if any, of the joggers along Boston’s Charles River could have realized the anticipation contained within the Hyatt Cambridge on a recent September Sunday morning.
In response to the growing relevance of Antibody Drug Conjugates (ADCs), the Boston Society kicked off its 11th annual Applied Pharmaceutical Analysis conference with a revamp of last year’s inaugural short course discussing this industry-stirring topic.Organized by Darshana Jani from Pfizer, the day’s sessions were led by a veritable “Who’s Who” of ADC All-Stars.
- Small and large molecule centers are no longer separate silos
- Scientists are increasingly frustrated with unclear regulation surrounding ADCs
The goal of the seminar was clear: provide intensive and in-depth training in the development, optimization, validation, and application of regulatory-compliant ADC bioanalysis.
It’s a clear objective, but far from simple. ADC bioanalysis can be a frustrating task for scientists attempting to navigate the vague language of current regulatory guidance from the FDA or EMA while working within best practices that are still being defined. Labs are often left feeling vulnerable to regulatory action and hyper-alert to maintaining compliance throughout the ADC development process.
A variety of guidance documents and white papers seek to further address these issues and define best practices surrounding ADCs:
- Workshop Report: Crystal City V-Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance
- 2014 White paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3-LBA and immunogenicity)
- Challenges in developing bioanalytical assays for characterization of antibody-drug conjugates
- Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics
As the pharmaceutical industry shifts increasingly toward analyzing large molecules, it was fitting that this year’s talks and posters gave equal attention to quantification and characterization of both large and small molecules throughout the program.
Dr. Erin Chambers’ talk on microflow LC/MS quantification of peptide and intact protein entities demonstrated the importance of cross-functional considerations when applying a surrogate peptide approach. So compelling was the information Dr. Chambers presented that attendees stayed, well beyond the conclusion and despite their lunch growing cold, to further discuss her data, sample prep techniques, and the development of large molecule analysis! We’ve make her talk available on video: