Manufacturing

EMA has published recommendations to address potential radiopharmaceutical shortages.

In discussions at INTERPHEX 2025, company representatives seized upon several common themes, most notably safety, sustainability, and the increasing utility of automation.

Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.

The concerns of industry experts expressed at INTERPHEX in April 2025 are still pertinent in an uncertain global political climate.

Six winners and two honorable mentions were revealed at ISPE’s Europe Annual Conference in London.

The proposed $700 million, 700,000-square-foot space will support the companies’ future joint portfolio of next-generation obesity medicines.

The company said the investment is in response not only to customer demand and a belief in the value of US-based innovation, but also because of the trend toward US onshoring brought about by new tariff policies.

Poor API quality may often lead to delays in production and a shortage of supply.

This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.

Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations regarding nitrosamines.

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.

Incorporating sustainable practices into process designs as early as possible ensures optimal performance.

The shift toward personalized medicines poses new challenges in cleanroom protocols.

Webinar Date/Time: Thu, May 22, 2025 11:00 AM EDT

The company’s exhibitions will be focused in the areas of its pipeline, proprietary capsid engineering, and manufacturing.

The commitment will include new, state-of-the-art R&D facilities as well as new or expanded manufacturing sites in multiple states.

Calculating the amount of drug needed for compounding requires different considerations for respective drug types and forms.

On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.

Development of the state-of-the-art facility was made possible by a £2 million (US$2.6 million) round of funding, and a successful inspection by MHRA was completed in March 2025.

The company has plans to invest $23 billion during the next five years to expand manufacturing and R&D in the US, which will include seven new facilities.

Siemens said spending on AI software is predicted to double by the end of the 2020s, in a market increasingly driven by structural shifts that underscore a need for digital transformation.

SkyCell is working with Microsoft to incorporate SkyCell’s AI-powered supply chain solution into Microsoft Teams and Copilot.

Lack of skills in the AI realm was a distant second among those surveyed about the biggest barrier to innovation while using the technology.

Joe Bobacher of OPW Engineered Systems spoke with Pharmaceutical Technology® Group at INTERPHEX 2025 about fluid transfer in controlled environments and the importance of guarding against product loss.

As single use becomes more prevalent, end users are looking for more customization, and regulators are refining their rules, says Todd Andrews of CPC in an interview with Pharmaceutical Technology® Group.

3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.

Michael Franco, global sales director at PSG Biotech, spoke with the PharmTech Group at INTERPHEX 2025 about recent advancements in pharmaceutical flow sensor technology.