
Developing An In Vivo CAR-T With Interius BioTherapeutics' Sianny Christanti and Babu Medi, Ph.D.
Better BiopharmaShow Notes
On this episode of Better Biopharma, Interius BioTherapeutics’ Sianny Christanti and Babu Medi, Ph.D., explain how the company is re-engineering a lentiviral vector to enable INT2104, its off-the-shelf, in vivo CAR T-cell therapy. They discuss the vector's design and its manufacturability, as well as the analytical and regulatory challenges of bringing this first-in-human therapy to the clinic. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Fo...
More from Better Biopharma
In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Will Olughu, Ph.D., global CMC lead and senior principal scientist at Ipsen, to talk about process modeling and AI applications in biopharma manufacturing. Olughu explains the distinction between static process models and dynamic digital twins, as well as the challenges of implementing digital twins in GMP environments (from data interoperability to model validation and regulatory considerations). Watch Olughu’s recent...
In this episode of "Better Biopharma," host Tyler Menichiello is joined by Tonix Pharmaceuticals' chief technical officer, Siobhan Fogarty, to discuss the planning and construction of its manufacturing facility in Dartmouth, MA, which was purpose-built for the production of its horsepox-based live viral vaccine platform, TNX-801. Fogarty details the design process and the challenges Tonix faced in the facility's construction, specifically highlighting the long equipment lead times and supply ...
In this episode of “Better Biopharma,” host Tyler Menichiello is joined by former FDA staffers Eva Temkin, partner at Arnold & Porter, and Elizabeth Trentacost, senior associate at Arnold & Porter. They reflect on 2026 regulatory developments and discuss the implications and nuances of Operation TrialBlazer. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Su...
In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Tatyana Matveeva, Ph.D., an expert in cGMP manufacturing and regulatory compliance. They discuss cell and gene therapy (CGT) manufacturing and the importance of maintaining quality unit independence within organizations, as well as some recent compliance violations at established manufacturing facilities. When it comes to CGT production, Matveeva advocates for a quality-by-design approach to protect patients and ensure...
In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Deck Bio’s chief scientific officer, Johanna Kaufmann, to discuss the company’s multi-peptide-MHC-targeted T-cell engager platform for solid tumors. Kaufmann explains the platform and reflects on the company’s journey through preclinical development. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichi...