Why Programmable Logic-Gated Cell Therapies Matter
Senti Biosciences executives Tim Lu and Claire Aldridge argued that next‑generation cell and gene therapies must employ programmable, logic‑gated designs to address diseases where traditional small molecules and biologics fall short. By integrating AI‑driven design and synthetic biology, these therapies can execute multi‑target killing of cancer cells while sparing healthy tissue. The speakers emphasized that precise delivery and dose control are critical to unlocking this potential. Their remarks were part of Cell & Gene Live’s discussion on smarter cell therapies.
Safer, Smarter Cell Therapies with AI
In a Cell & Gene Live segment, Claire Aldridge, Ph.D., emphasized that AI and synthetic biology breakthroughs depend on proprietary, well‑annotated experimental data that continuously train models. Tim Lu, M.D., Ph.D. of Senti Biosciences explained how logic‑gated designs combined with...
AI-Designed Logic Circuits for Smarter Cancer Targeting
Senti Biosciences unveiled an AI‑guided workflow that designs paired activating and inhibitory chimeric antigen receptors (CARs) to create logic‑gated circuits for cell therapies. The system automatically optimizes CAR combinations, enabling more precise discrimination between cancerous and healthy cells and delivering...
The Tradeoffs Of Continuous Processing
The panel addressed a recurring audience query about whether continuous processing—specifically harvesting antibody‑producing bioreactors and loading directly onto Protein A chromatography—can be implemented under GMP conditions. The discussion framed the issue as a balance between upstream output and downstream handling, asking...
Making Biologics Orally Available With Vivtex's Thomas Von Erlach, Ph.D.
The interview with Thomas von Erlach, Ph.D., co‑founder and CEO of Vivex, focuses on the company’s breakthrough gastrointestinal‑on‑a‑chip platform that makes biologic drugs orally bioavailable, a stark contrast to traditional injections or IVs. Von Erlach outlines how the technology, conceived...
The Conjugation Conundrum: The Realities of Conjugated LNP Manufacturing
The discussion centers on the emerging complexities of conjugated lipid nanoparticle (LNP) manufacturing, a shift from standard platform processes toward targeted RNA delivery. Sujit explains that adding a biologic ligand to LNPs forces manufacturers to revisit every process parameter—viscosity, shear...
The “Art” Of the Linker: Complexity, Biodegradability, and Scale in Active LNP R&D
The panel examined the emerging “active” delivery paradigm for lipid nanoparticle (LNP) therapeutics, focusing on the added layers of complexity introduced by ligand‑modified formulations and the need for robust R&D pipelines. Participants contrasted passive LNPs with active, ligand‑decorated versions, highlighting...
The Challenges Novel Lipids Pose For mRNA-LNP Manufacturing
Novel lipid chemistries are accelerating mRNA‑LNP innovation, but they also upend established manufacturing platforms. According to CMC consultant Sujit Jain, each new lipid class forces a fresh round of process development, demanding new impurity profiling strategies and vendor qualification. The...
Novel Lipid Chemistries & Their Impact on Passive LNP Delivery
In a recent Advancing RNA Live session, Dominik Witzigmann of NanoVation and John Zuris of Stealth Co dissected emerging lipid chemistries that enhance passive lipid nanoparticle (LNP) delivery. They highlighted breakthroughs in ionizable lipids, helper lipids, and PEG‑lipids that improve...
How Microfluidics & QbD Are Maturing LNP Manufacturing
In a recent discussion, CMC consultant Sujit Jain and NanoVation CEO Dominik Witzigmann highlighted how microfluidic platforms combined with Quality‑by‑Design (QbD) principles are transforming lipid nanoparticle (LNP) production for mRNA therapeutics. They noted that continuous‑flow microfluidics now enable precise control...
Primates, Patents, & Progress: Advancements In Rational LNP Design
In a recent Advancing RNA Live segment, Dominik Witzigmann of NanoVation Therapeutics and John Zuris of Stealth Co discussed the latest scientific breakthroughs shaping lipid nanoparticle (LNP) design. They highlighted rational, data‑driven approaches that improve particle stability, targeting precision, and...
The Evolving CMC Landscape for mRNA-LNPs
In a recent Advancing RNA Live segment, CMC consultant Sujit Jain outlined the current maturity levels across process development, analytical methods, and supply‑chain logistics for mRNA‑LNP products. He highlighted that COVID‑19 vaccines and liver‑targeted therapeutics now operate on a reproducible,...
Knowing How Injection Volumes Impact Delivery Options
The panel discussed how the volume that can be self‑administered determines whether a therapy is delivered via a pre‑filled syringe (PFS), an autoinjector, or an infusion system. Speakers emphasized that the deciding factor is the drug’s pharmacokinetic profile. Antibodies that merely...
Relying On Human Factors Clinical Data For Regulatory Approvals
The discussion centered on the growing regulatory focus on human‑factors engineering in medical‑device submissions, especially within the FDA’s Center for Devices and Radiological Health. Participants noted that the agency’s human‑factors experts have become more visible over the past decade, and...
Preparing Early For Regulatory Marketing Submissions
The video addresses how companies should begin planning regulatory marketing submissions well before a product reaches the market, emphasizing patient‑centricity and the imperative of rapid access to therapies. It argues that early alignment of clinical trial design with the data...
Monitoring Patient Preferences And Post-Market Safety
The Drug Delivery Leader Live panel highlighted the growing emphasis on patient‑centric post‑market surveillance for injectable, infused, and implanted therapies. Shannon Hoste explained how manufacturers now track patient preferences and safety outcomes after product launch. Real‑world data and digital tools...
Selecting Injection Devices And Platforms
During the Drug Delivery Leader Live webcast, chief editor Tom von Gunden asked panelist Fran DeGrazio how dosing considerations drive the choice of injection devices and platforms. DeGrazio explained that dose volume, drug viscosity, and administration frequency are the primary...
Confirming Study Approaches For Clinical Bridging
During the Drug Delivery Leader Live event, Chief Editor Tom von Gunden prompted panelist Beate Bittner to discuss patient‑centric considerations as drug and delivery products transition to clinical trials. Bittner emphasized that leveraging established platforms and data from previous studies...
Determining Dosing For IV Or Subcutaneous Delivery
In a Drug Delivery Leader Live session, panelist Beate Bittner discussed early‑stage formulation decisions from a patient dosing perspective, comparing intravenous (IV) and subcutaneous (SC) routes. She highlighted how drug stability, bioavailability, administration frequency, and patient convenience shape the choice...
Company Turnarounds And AI For Infectious Diseases With Seek Labs' Jared Bauer
Jared Bauer, co‑founder and CEO of Seek Labs, detailed his experience turning around biotech firms and launching an integrated AI‑diagnostic and CRISPR‑therapeutics platform for infectious diseases. He highlighted a proof‑of‑concept study against African Swine Fever that markedly reduced viremia in...
