Manufacturing

FDA approves inhaled insulin Afrezza for children aged 6+, expanding pediatric diabetes care and highlighting inhaled biologics' manufacturing complexity.

This week's news and expert commentary shows that regulatory timelines are tightening, strategic capital is moving into new therapeutic categories, and long-standing operational gaps are demanding real solutions.

The cell and gene therapy manufacturing workforce is having to expand on deliverables while remaining under trained.

Pharmaceutical serialization must evolve from regulatory compliance into operational intelligence, addressing hidden failures like exception overload, certificate expiry, and 3PL complexity.

European biotechnology companies are increasing patient access to innovative cell and gene therapies through decentralized next-generation manufacturing platforms.

Bristol Myers Squibb collaborates with Anthropic to accelerate drug development, manufacturing quality systems, and regulatory documentation via AI integration.

Stuart Tindal, Sartorius, and David Chau, Thermo Fisher, discuss automation, single-use technology limits, and predictive control shaping continuous bioprocessing's future.

Deborah Smook, co-founder and co-owner of TurboFil Packaging Machines, explains some of the challenges involved with prefilled syringe manufacturing.

Building resilient, adaptable operations capable of evolving alongside the rapid transformation of the biologics industry is key for downstream processing.

Valerie Bandy, Tecsys, explains how proactive vendor relationships, strategic drug allocation, and end-to-end visibility can prevent costly pharmaceutical supply disruptions.

Bristol Myers Squibb’s Hengrui agreement underscores how China-based early development may influence portfolio and manufacturing decisions.

This article evaluates a structured, risk-based framework for the development, execution, and life cycle governance of master production and control records and batch production and control records systems aligned with current good manufacturing practice requirements and internationally harmonized pharmaceutical quality system guidance.

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.

Lilly expanded its Indiana manufacturing investment by $4.5 billion to support tirzepatide, oral glucagon-like peptide-1, and genetic medicines.

Visual inspection injectable products may be enhanced by the utilization of AI to analyze and link data to identify deviations, trends, or irregularities.

In this episode of Manufacturing Intelligence, we break down digital twin use in pharma, from risk reduction and scale-up modeling to AI integration and virtual inspections.

Daniele Ansaldi, technical manager for Automated Inspection Machines at Antares Vision Group North America, outlines some of the challenges of performing visual inspections on prefilled syringes.

Webinar Date/Time: Fri, May 29, 2026 11:00 AM EDT

The industry is feeling the push to modernize facilities and manufacturing processes.

This article provides a statistically defensible and GMP-aligned justification for continued IPC reliance on computed net fill weight when equivalence in mean and variance can be demonstrated.

Peter Makowenskyj, senior director of Design Consulting at G-CON, and Beata Sweryda-Krawiec, associate director at Boehringer-Ingelheim, discussed trends influencing the design of pharmaceutical manufacturing facilities during a Quick Fire Learning Lab at INTERPHEX 2026.

Panelists at INTERPHEX 2026 talked about the move to hybrid modeling for process development and the barriers to the adoption of artificial intelligence in pharmaceutical manufacturing.

Winners in 8 categories were announced at ISPE’s Europe Annual Conference.

Ranjit Deshmukh, Principal, BiologixCMC, discusses how contract manufacturers can optimize their processes and plan for the future by optimizing facility design.