Unveiling bioanalytical datasets for the successful development of ADCs

Bridging science and safety: exploring toxicology studies and regulatory requirements

This International Women’s Day, we’re joined by Lindsay Davies, Chief Scientific Officer at NextCell Pharma (Stockholm, Sweden), to discuss the evolving role of cell therapies in treating autoimmune diseases.

In this podcast, Davies breaks down the science behind NextCell’s mesenchymal stromal cell therapy for type 1 diabetes and explores how these cells could be applied to other autoimmune conditions. She emphasizes the importance of tailoring cell therapies based on disease type, stage and patient profile to achieve the best outcomes.

The conversation also highlights how growing evidence of sex-related differences will could increasingly shape decisions in the development and testing of cell therapies.

During the American Association of Pharmaceutical Scientists (AAPS) PharmSci 360 2024 conference, Bioanalysis Zone caught up with industry experts across numerous disciplines to discuss their involvement with AAPS and their research. In this interview, we spoke to Priyata Kalra about her talk on the use of GenAI within biomedicine.

In this episode, we sit down with Megan Cooley, Associate Director of Bioanalytical Services at ICON (KS, USA), to explore the cutting-edge world of antibody-drug conjugate (ADC) quantitation using high-resolution mass spectrometry (HRMS). Megan delves into the capabilities of Triple Quadrupole and Time-of-Flight mass spectrometry, offering her expert insights into whether HRMS is essential for ADC PK studies. We also tackle the challenges and limitations of HRMS in ADC quantitation and discuss the potential for AI to create more specific and stable ADCs. Finally, Megan highlights ICON’s extensive experience with large molecule applications and their innovative approach to supporting complex LC–MS analyses.

In this interview, we discuss the potential of AI in increasing healthcare system efficiency, how medical devices are making procedures less invasive and what those working in the field of medical devices can do to help regulation catch up with innovation.

In the sixth episode of The new frontier podcast, we're joined by Catherine Vrentas, Life Sciences Lead at Booz Allen Hamilton (VA, USA). Cathy explains how biomarkers can be used to predict the therapeutic outcome and efficacy of CGTs and the biomarkers in particular that have shown strong predictive value. We delve into the common challenges of working with biomarkers in CGTs and how biomarker kits can be adapted for CGT work.

Carlon Fitzpatrick AI Summit by Taylor & Francis Group

Challenges and solutions in monitoring assay performance for vaccine development: an interview with Atul Chaudhari

We caught up with Principal Scientist Lindsay Denhoff (ICON; Dublin, Ireland) to discuss immunogenicity considerations for therapeutic proteins and the current analytical methodologies for detecting and characterizing anti-drug antibodies (ADAs). Lindsay shares some industry best practices for achieving high-quality ADA assays, as well as some of the advantages and limitations of singlicate ADA analysis compared with alternative techniques. We finish the interview with a look to the future where Lindsay discusses the emerging trends she's spotted in the field of immunogenicity and offers her predictions for how they may shape the future of therapeutic protein development.