Manufacturing

Fosun Pharma has dosed the first participant in a mainland China trial of FXB0871, as a parallel phase 1 study continues in the United States and Canada under Teva's TEV-56278 designation

Rohan Kumar, laboratory analyst at CS Analytical, discusses how sustainability in pharmaceutical packaging can be improved.

Contract development and manufacturing organizations can assist the sponsor company in ensuring sterility assurance in alignment with the EU’s Annex 1 guidelines.

Andrea Zobel and Marco Hogenboom of Cencora World Courier discuss the operational and logistical challenges shaping the radiopharmaceutical sector as therapies move toward broader commercialization. The executives outline how regulatory complexity, short delivery windows, AI-enabled logistics systems, and global coordination requirements are redefining advanced therapy supply chains.

Charles River Laboratories’ Dr. Alan K. Smith explains how early commercial planning, modular manufacturing, and AI-driven automation may accelerate scalable manufacturing for cell and gene therapies.

Risk-based ADC cleaning validation must integrate degradation profiling, HBEL-aligned analytical methods, and dual large/small molecule strategies for facility safety, according to STERIS technical services director, Paul Lopolito.

Updated RestorAATion-2 data show durable M-AAT restoration and Z-AAT reduction across biweekly and monthly dosing regimens, with FDA accelerated approval pathway feedback anticipated mid-2026

Automation, isolators, and AI-driven analytics are reshaping aseptic filling while boosting sterility assurance, flexibility, and GMP compliance.

AI and PAT have been shown to reduce manufacturing variability in advanced therapies, which leads to improved process control and accelerated patient access to lifesaving treatments.

Automated density gradient ultracentrifugation boosts the efficiency of AAV purification.

Webinar Date/Time: Thu, May 21, 2026 11:00 AM EDT

AI and automation may streamline cell and gene therapy manufacturing by reducing labor demands while improving efficiency and supporting scalable production, says Dr. Alan Smith of Charles River Laboratories.

Dr. Alan Smith of Charles River Laboratories explains why early manufacturing planning and scalable processes are critical to ensure successful commercialization of complex cell and gene therapies as part of his panel discussion at INTERPHEX 2026.

ADC cleaning validation requires risk-based strategies to manage degradation and ensure safe limits for highly potent, dual-modality therapeutics, says Paul Lopolito, STERIS’ director of Technical Services, at INTERPHEX 2026.

With the closing of an acquisition, ROIS adds high-potent fill/finish and lyophilization capabilities to support biologics and ADC pipelines, addressing global supply and scalability challenges.

As 2026 marches forward, the biopharma industry finds itself balancing therapeutic innovation with operational discipline across manufacturing, data integrity, and next-gen precision medicine

Webinar Date/Time: Thu, Apr 30, 2026 11:00 AM EDT

Webinar Date/Time: Tue, May 19, 2026 11:00 AM EDT

BioNTech’s decision to close its Singapore manufacturing facility reflects mounting financial pressure, ongoing restructuring efforts, and uncertainty around the pace at which next-generation mRNA therapies will scale.

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 phase 3 data from AstraZeneca suggest that adding systemic agents to embolization can significantly delay disease progression in early hepatocellular carcinoma.

Experts from Acuitas, Mana.bio, NanoVation, and ReCode share their input on targeted LNP engineering, which is accelerating pipeline expansion of nucleic acid therapies for chronic and rare diseases beyond the liver.

Christopher Locher, PhD, CEO, Versatope Therapeutics, discusses how emerging vaccine platforms are advancing the pursuit of a universal influenza vaccine, while highlighting the scientific, regulatory, and economic barriers that continue to shape its path to reality.

The approval introduces a one-time gene therapy for LAD-I that restores immune function and addresses the underlying cause of a life-threatening pediatric disease.

Phase 3 data from AstraZeneca show IL-33 inhibition reduces COPD exacerbations across broad populations, supporting a new biologic approach beyond eosinophil-driven disease.