Manufacturing

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.

Subcutaneous infliximab may help improve treatment convenience, dosing consistency, and long-term adherence for patients with inflammatory bowel disease, according to discussions at DDW 2026. Clinicians highlighted the potential for self-administered infliximab to support sustained remission while reducing infusion-center burden and improving patient-centered care.

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.

Dr. Edwin Stone, CEO of Cellular Origins, emphasizes that scalable manufacturing must support, not limit, development of safe and effective biological therapies like cell therapies while speaking at the 2026 ASGCT Annual Meeting.

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

Cell therapy developers are prioritizing scalable manufacturing strategies alongside efficacy to support broader commercial deployment, notes Cellular Origins CEO Dr. Edwin Stone at the 2026 ASGCT Annual Meeting.

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.

Hypoimmune cell engineering may enable scalable type 1 diabetes therapies without immunosuppression, advancing regenerative medicine approaches, according to Dr. Steve Harr, president and CEO of Sana Biotechnology.

Automated density gradient ultracentrifugation boosts the efficiency of AAV purification.

Highlights at INTERPHEX 2026 include digital integration and supply chain innovation to improve scalability, resilience, and efficiency in biomanufacturing.

In the second half of an interview at the close of INTERPHEX 2026, Avantor’s Jerry Keybl explains that digital integration and AI-driven analytics enable predictive bioprocess control and can thus improve consistency, scalability, and data-driven manufacturing decisions.

Consistent fluid management across scales supports efficient bioproduction and reduces risk during scale-up of complex therapeutic modalities, says Avantor’s Jerry Keybl at INTERPHEX 2026.

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.