Manufacturing

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.

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

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.

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

CPHI Americas 2026 tackles pharma's pressing challenges such as: regulatory shifts, AI in drug discovery, biologics innovation, and supply chain resilience.

Interpack 2026 previews filling, labeling, and packaging equipment from Uhlmann Group, groninger, and HERMA designed for pharmaceutical manufacturers.

Webinar Date/Time: Thu, May 14, 2026 2:00 PM EDT

Richard Jaenisch and Christopher Cole discuss AI in pharma manufacturing, covering learning steps, output evaluation, hallucinations, and FDA/EMA guiding principles.

This article highlights how quality control microbiology is evolving into a proactive, integrated component of modern contamination control strategies across the biopharmaceutical lifecycle.

Understanding how factors such as excipient choice affect nitrosamine formation is essential to developing safer, lower-risk pharmaceutical formulations.

Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about efforts in anticounterfeiting and the use of predictive modeling to validate transport conditions.

This article details what co-processed excipients are and how they are made.

The industry is seeing a shift toward integrated process intelligence and new regulatory pathways.

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

FDA’s Project Optimus shifts oncology dosing from MTD to balancing efficacy and safety via metrics like Net Treatment Benefit to pick doses.

This article explores key engineering strategies that support this transformation, including hybrid reactor design, clean-in-place optimization, automation architecture, and modular scalability.

Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about the technologies being used to fight counterfeiting and how predictive modeling can be used to validate transport conditions.

Olon is expanding global biologics and high-potency manufacturing capacity across four countries, with major ADC chain investments completing in 2026.

Industry experts explain how incorporating sustainability into the early development phase creates greener pharmaceutical manufacturing.