Manufacturing

EMA’s draft GMP Annex 22 sidelines LLMs in critical manufacturing, fueling a push for risk-based guardrails and human accountability.

Pen injector pre-assembly demands 160 PPM precision: LVDT/vision systems, tolerance control, and GAMP5 challenge testing ensure ISO 11608 compliance.

Richard Jaenisch, Open Biopharma breaks down AI's real limits in drug discovery, agent security risks, and what workforce readiness looks like by 2028.

This year’s conference agenda includes more than 260 industry experts, a new Sustainability Summit, and zones targeting AI, cold chain, and labeling.

BMS's Investing $2.3B into its Houston campus signals a shift toward flexible, multi-modal manufacturing.

A phased playbook for moving life sciences data warehouses to a compliant, AI-ready cloud Lakehouse, balancing GxP rigor with faster insights.

New 250-gallon retention mixers rated to 200 psi help pharma manufacturers maintain product uniformity and cut transfer risk.

Content on PharmTech.com this week showed that while AI is being utilized in drug discovery, manufacturing execution still lags behind. However, manufacturers are rethinking where and how they build capacity, transfer technology, and monitor quality in real time.

Across development, manufacturing, quality, and outsourcing, the pharma industry is being asked to scale complexity without sacrificing control.

This episode of Pharma Fundamentals provides an introduction to hold times in biopharmaceutical manufacturing and how they differ from hold times in small-molecule drug manufacturing.

In part 2 of this 2-part interview, Jason Bock, founder and CEO of CTMC provides input on how the FDA's proposed manufacturing registration rule may impact personalized therapies.

FDA revises draft guidance for 17 generic peptide products, including semaglutide and tirzepatide, updating testing standards ahead of a September comment deadline.

Jason Bock, founder and CEO of CTMC, provides his perspective on the FDA’s proposed rule to streamline registration for single distributed manufacturing establishments, and what the change may mean for personalized medicines.

In part 2 of this 2-part discussion, our panelists explain how to maintain technical oversight without micromanaging and how one can align tech transfer and regulatory strategies to avoid commercial supply gaps.

Pharma manufacturing and development experts reassess their 2026 predictions for the industry and look ahead to the second half of the year.

In part 1 of this 2-part discussion, our panelists explain how to structure a tech transfer package, handle gaps in process understanding, and qualify analytical methods.

Megha Sinha, Kolter AI explains how Pharma has automated drug discovery and manufacturing AI, but not regulatory execution.

AI is reshaping discovery, manufacturing, and supply chain routing. Manufacturers are investing in capacity and resilience.

Brent Wilhelm of Cencora talks about real-time demand data, last-mile carrier risk, and a $1 billion investment in cold chain pharma resilience.

Megha Sinha, Kolter AI, discusses how pharma's AI bottleneck shifted from technology to readiness as execution across 60 markets stays manual.

Brent Wilhelm, Cencora, comments on cold chain pharma growth, a $1B supply chain investment, and a 2027 hub built to curb drug shortages.

Megha Sinha, Kolter AI, talks on how orchestrator roles surged in pharma AI, but teams need computed plans, not titles, to close the skills gap.

Novo Nordisk’s complaint contends that Lilly's campaigns leave out information about the most effective injectable doses of Wegovy (semaglutide) and Ozempic (semaglutide) currently on the market.

The use of artificial intelligence is facing harder questions of governance and data quality, and regulators in the United States and the European Union are streamlining pathways to market.

Brent Wilhelm, Cencora, talks on last-mile drug delivery risks, carrier network visibility, weather disruptions, and how AI could improve routing.