Future Science Group

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 Future Science 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.

In this Tech Blast episode supported by Sartorius (Göttingen, Germany), we speak with David Apiyo – Manager of Applications Development at Sartorius (MN, USA) – about epitope binning, why it's performed and the best ways to conduct it. Plus, learn more about Sartorius' biolayer interferometry platforms and their application in epitope binning.

In this interview, we spoke to John Chappell, Senior Global Scientific Support Manager at Gyros Protein Technologies (Uppsala, Sweden) about his experience working with the Gyrolab platform for oligonucleotide assays. John discusses the advantages of using Gyrolab for oligo quantification in biological fluids and shares his thoughts on the next steps for these assays.

In the fifth episode of The New Frontier podcast, we're joined by Paul Byrne, Senior Director of Genomics from ProtaGene (MA, USA). Paul describes his experience working with qPCR vs digital and digital droplet PCR assays and advises on their pros and cons, as well as when it's best to use each. We discuss how these assays can be optimized for cell and gene therapy targets and get a peek into the tips and tricks he's picked up over his 30 years of experience.

In this episode of The New Frontier podcast, we're joined by Daniel Schulz-Jander, Senior Director of Mass spectrometry Bioanalysis at QPS Netherlands (Groningen). Daniel explains how he uses immune-precipitation and immunoaffinity LC–MS techniques for his work relating to macromolecular pharmaceuticals like gene therapies, as well as their benefits and challenges. Daniel also covers bottom-up, middle-down and top-down approaches and their suitability for his work in clinical support versus research and discovery.

Breaking down barriers for women in tech: an interview with Tina Marshall by Future Science Group

What disparities exist in cancer screening and how does this impact patient outcomes? Listen to our latest podcast episode with Kilan Ashad-Bishop (American Cancer Society) to find out about the intersection between science, health, and society.

AI-driven early disease detection: an interview with Jim Kean by Future Science Group

In this episode, we spoke to Senior Director Johanna Mora about her experience with immunogenicity testing for cell and gene therapies (CGTs) and how she prepared for the expansion of BMS's portfolio to include CGTs. We discuss the importance of having diverse teams with a broad range of experiences to solve complex problems, as well as the role of artificial intelligence in improving our efficiency and spotting patterns in the data.

In the first episode of this series, we spoke to Executive Director and Global Head of Regulatory Services Kimberley Buytaert-Hoefen about her experience with cell and gene therapy (CGT) approvals and the barriers to getting these important therapeutics to the patient. Kim advises early regulatory interaction and collaboration to improve the success rate of applications and emphasizes the importance of global harmonization of regulatory standards. We discuss key barriers to CGT approvals including manufacturing and immunogenicity and Kim voices her excitement for the newly approved CRISPR-Cas9 technology to treat sickle cell disease.

AI and the UK Biobank: an interview with Mahesh Pancholi