Precision by design: engineering site‑specific ADCs with machine learning

Lauren Coyle (Editor, BioInsights) speaks with Lonza's Laura Sands (Head of Regulatory Affairs), Ramesh Koukuntla (Director of R&D), Wenling Dong (Head of Upstream Process Development), and Vijetha Bhat (Subject Expert of Platform Technologies) about:Key regulatory considerations when transitioning to AAV producer cell lines Comparability and bridging strategies to support a successful transition Approaches to managing manufacturing and regulatory risk Considerations for enabling scalable AAV production

Lauren Coyle, Editor, BioInsights, speaks with Christian Overgaard, Senior Field Application Scientist, Bio‑Rad Laboratories, about the technical and practical evolution of droplet digital PCR (ddPCR) and high‑plex multiplexing, covering assay design challenges, vector integration analysis, biodistribution studies, and the emerging role of digital PCR in cell and gene therapy characterization and clinical development.

The one‑and‑done model has defined gene therapy for a generation. Chris Hopkins thinks it is time to move on. At ASGCT 2026, Abi Pinchbeck spoke with the Co‑founder and CEO of Glafabra Therapeutics on redoseable cell‑based gene therapy, a platform spanning Fabry, Pompe, and Gaucher diseases, and what durable, if not permanent, treatment could mean for patients. A podcast version of this discussion is also available.

Lauren Coyle, Launch Commissioning Editor, Bioconjugate Insights, speaks with Weston Kightlinger, CEO, Ridge Bio, about the challenge of DAR heterogeneity and site specificity in ADC development, Ridge Bio’s ML‑driven enzyme and linker engineering platforms, and what site‑specific conjugation means for the future of ADCs as the field moves beyond oncology.

Lauren Coyle, Launch Commissioning Editor, Bioconjugate Insights, speaks with Antoine Yver, Board Chair, Ona Therapeutics, with more than three and a half decades of experience shaping global cancer drug development. In this conversation, they explore what determines whether an ADC successfully crosses the critical threshold and how teams should rethink dose finding, toxicity, and what it truly takes to set a program up for long-term success in the clinic. 

In this interview, Róisin McGuigan, Editor, Nucleic Acid Insights, and Jesse Erasmus, Director of Virology at HDT Bio, discuss current challenges and opportunities in RNA safety, manufacturing, and targeted delivery, and the key ongoing obstacles facing viral and LNP-based delivery modalities.

In this podcast episode, Jokūbas Leikauskas, Editor, BioInsights, speaks to Trevor Hallam, who served as Chief Scientific Officer of Sail Biomedicines until July 2025. The interview, recorded in June 2025, explores advances in RNA therapeutics, particularly circular RNA (circRNA or eRNA) technologies, and how they may help overcome current limitations in delivery, durability, and specificity for applications such as CAR-T cell therapies and autoimmune disease treatment.

Lauren Coyle (Commissioning Editor, Bioconjugation Insights) speaks to Vincent Rotello (Distinguished Professor of Chemistry, University of Massachusetts Amherst) about the advantages and limitations of different nanomaterial platforms, and emerging strategies such as tissue tropism and responsive nanozymes that could advance targeted therapeutic and diagnostic delivery.

Lauren Coyle, Launch Commissioning Editor, Bioconjugation Insights, speaks with Kerstin Hofer, Science and People Lead, Roche, about the evolving application of antibody-oligonucleotide conjugates in neurology. She highlights their design, delivery challenges across the blood–brain barrier, and potential to transform CNS diseases.

Jokūbas Leikauskas, Editor, BioInsights, speaks to Rohin Iyer, Senior Director, Global Cell and Gene Therapy Operations, Marken, about addressing the complex logistics of cell and gene therapies through global infrastructure, precision, and advanced technologies. They also discuss evolving cold chain needs, regulatory and geopolitical challenges, and the need for scalability.