KCAS Bio participated in the AAPS National Biotechnology Conference (NBC), held from May 4 to May 7, 2025, in Boston. It was a productive event that allowed us to connect with sponsors, exchange ideas with peers, and present our latest work in bioanalytical science.
Our experts had the opportunity to present at the event:
Poster Presentation
In his poster presentation, Ryan Darling introduced a novel immunoprecipitation method designed to streamline clinical bioanalysis workflows for ADCs. This high-throughput approach offers greater efficiency, improved precision, and faster insights to support critical decision-making during development.
Podium Presentation
Our session, titled “PK and ADA Bioanalysis Support for ARCs and siRNA: Case Studies”, was presented by Dawn Dufield and Lindsay Rutherford. It focused on two examples that demonstrated our hybrid LC-MS/MS technical problem-solving and practical experience in assay development and was the largest attended talk at the event.
Case Study 1: ADA Assay Development for siRNA
Challenge
A client required an ADA assay for a siRNA molecule intended for clinical evaluation. The initial drug format lacked free amines, which ruled out standard labeling strategies. Additional challenges included the complexity of generating anti-RNA antibodies.
Solution
We developed a bridging ADA assay format that allowed us to work around the initial absence of free amines. Despite the technical limitations, we successfully validated the method according to regulatory standards.
Case Study 2: Oligonucleotide Assays in Multiple Species and Matrices
Challenge
The objective was to support the analysis of oligonucleotides across several species and biological matrices. The client preferred a general approach that could reduce development time while maintaining accuracy.
Solution
We applied a high-resolution mass spectrometry (HRMS) method in full scan mode, which enabled initial evaluation of each oligonucleotide, species, and matrix combination. After validation, we were able to analyze pharmacokinetic samples with consistent performance. The assays achieved lower limits of quantification (LLOQ) between 1 and 20 ng/mL.
In addition, there were several topics that were frequently discussed by attendees and sponsors.
New Therapeutic Modalities and Reagent Considerations
Several topics generated significant interest during the conference, including oligonucleotides, siRNA, antisense oligonucleotides (ASOs), and hELISA methods. Attendees frequently raised questions about the evolving landscape of therapeutic modalities and the growing need for external support in bioanalysis.
Antibody-drug conjugates (ADCs) were also a recurring topic, especially regarding the complexities of working with neutralizing antibodies (NAbs) and anti-drug antibodies (ADAs). Discussions often focused on the availability and characterization of critical reagents for these assays, as well as interest in our mass spectrometry approach to ADC analysis.
Interest in Off-the-Shelf Assays
Many of our conversations at AAPS NBC highlighted the increasing demand for off-the-shelf or validated assays, particularly for widely studied compounds such as semaglutide. This reflects a broader industry trend toward more efficient solutions that can be quickly deployed, especially in the context of GLP-1 analog studies. We are currently evaluating options to address this emerging need.
Supporting Bioanalysis with Speed and Flexibility
Operational challenges such as internal capacity limitations and long project lead times were frequently mentioned. We shared examples of recent projects where we were able to onboard and execute work in 1.5 weeks and 3 weeks, respectively. These projects were made possible by our planning process and ability to respond quickly to changing timelines. This level of responsiveness was recognized by attendees as a key strength in collaborative partnerships.
Continuing the Conversation
We appreciate the opportunity to engage with so many professionals at AAPS NBC 2025. If you are exploring new bioanalytical strategies or seeking a flexible partner for your studies, we welcome the opportunity to discuss how we can support your goals.