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Circio CEO Highlights Circular RNA Potential for Safer, More Efficient Gene Therapy

Circio CEO Erik Wiklund discussed how circular RNA technology may improve the safety, durability, and cost-efficiency of AAV gene therapies for cardiovascular diseases at ASGCT 2026. Early animal data suggest the platform reduces cellular stress responses while increasing gene expression, potentially expanding access to safer and more scalable gene therapy treatments.

Mechanical Robustness of 2R Glass Vials Across Fill/Finish Operations: Implications for Biopharma Manufacturing

While allowing for high throughput and efficiency, the bulk fill/finish process exerts extreme stress on glass containers, resulting in cosmetic defects and breakage.

New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.

The Ron Lanton Report: What Are We Doing This All For?

Melanie Whittington, managing director and head of the Leerink Center for Pharmacoeconomics, joins Ron Lanton to argue that biopharmaceutical policy only makes sense when traced back to its purpose.

Single-Use Technology: Transforming Biomanufacturing Today and Tomorrow

Advanced technology platforms optimize the efficiencies and sustainability of single-use bioreactors, setting the scene for the next evolutionary step in biomanufacturing.

Developing Next-Gen Cell Lines Using Targeted Integration

Targeted integration enables predictable clonal cell lines, enhancing transgene control and accelerating biopharma cell line development.

Digital Transformation in Pharmaceutical Manufacturing

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.

Ask the Expert: Rethinking Preclinical Development Through Predictive Models and Human-Relevant Data

Advances in predictive modeling, translational bioanalytics, and human-relevant research systems may help reduce reliance on animal testing while improving the clinical relevance of preclinical drug development. Experts say these approaches could streamline IND preparation, lower costs, and support more informed decision-making across biopharmaceutical R&D.

Formulation Strategies, Tech Advances, Challenges, and Considerations in Novel Drug Delivery

The transformative impact of complex biopharmaceuticals hinges on integrating advanced delivery systems, often accelerated by AI modeling, with robust manufacturing practices and regulatory alignment to ensure stability, safety, and effective patient access.

The BioPharm Brief: Survival, Scrutiny, and a Setback

Today’s BioPharm Brief looks at a phase 3 survival win for Imdelltra plus Imfinzi in first-line small cell lung cancer, FDA review of Rezolute’s ersodetug, and Novartis’s del-desiran setback in myotonic dystrophy type 1.

Nanobiotix CEO Discusses How Physics-Based Drug Delivery Could Improve Therapeutic Performance

Laurent Levy, founder and CEO of Nanobiotix, explains how a physics-based approach to drug delivery could complement existing therapeutic platforms by improving particle behavior in the body while avoiding added complexity.

Developing Next-Gen Cell Lines Using Targeted Integration

Targeted integration enables predictable clonal cell lines, enhancing transgene control and accelerating biopharma cell line development.

Dr. Alexander Shoushtari Discusses Five-Year Kimmtrak Data and the Future of TCR Therapy in Metastatic Uveal Melanoma

New five-year data from the Phase 3 tebentafusp (brand name Kimmtrak) trial are continuing to generate attention across oncology, particularly in metastatic uveal melanoma, a rare and historically difficult-to-treat cancer with limited treatment options and poor long-term survival outcomes. The study, presented during the 2026 annual meeting of the American Association for Cancer Research, represents the longest prospective Phase 3 randomized trial to report five-year overall survival data in metastatic uveal melanoma and the longest follow-up study for any T-cell engager in a solid tumor.

Best Practices for Quantification of Residual Host Cell DNA with Real-time PCR

Benchmarking Quality Systems in Cell and Gene Therapy: Insights from Yelena Ionova

Yelena Ionova, Pharm.D., Redica Systems, discusses how benchmarking inspection data, strengthening sterile manufacturing controls, and adopting continuous regulatory intelligence strategies can help cell and gene therapy manufacturers improve inspection readiness and quality system performance.

CRISPR Gene-Editing Technology in the Development of Biopharmaceuticals

Novel nucleases with diverse properties represent promising solutions, emphasizing their potential to overcome current limitations in genome editing and therapeutic delivery.

MHC-Associated Peptide Proteomics: Immunogenicity and Vaccine Design

This article looks at how the MAPPs assay works, how it integrates with other immunogenicity assays, and just how it can be flipped to help in vaccine design.

The Growing Importance of Chromatography in Biologics Production

Liquid chromatography and single-use chromatography platforms are reshaping biologics purification as the Asia-Pacific region challenges the dominance of North America and Europe.

Gene Therapy Unlocked: Overcome Challenges and Accelerate the Path to Patients

A long-term, trust-based CDMO partnership can support cell and gene therapy developers from early process development through GMP manufacturing and commercial supply.

A Novel, Enhanced, and Sustainable Approach to Audit Trail Review

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.