Manufacturing

Biopharma in 2026 advances decentralized manufacturing, AAV automation, QC modernization, and APAC clinical trial strategy.

BioNTech and Bristol Myers Squibb report confirmed ORRs exceeding 60% at the lower dose in both non-squamous and squamous first-line NSCLC; three global Phase 3 trials are now enrolling.

Webinar Date/Time: Wed, Jun 24, 2026 11:00 AM EDT

Point-of-care manufacturing could expand personalized medicine by enabling faster, decentralized drug production, though quality and regulatory hurdles remain.

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.

SENN Development CEO Dr. Johannes Eisenhut discusses how Basel’s expanding life sciences ecosystem supports biopharma innovation through research infrastructure and specialized talent growth.

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.

Celltrion’s Dr. Juby Jacob-Nara discussed how subcutaneous infliximab may improve convenience, adherence, and sustained remission for patients with inflammatory bowel disease, while reducing reliance on infusion centers and supporting broader patient-centered treatment goals.

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.