Manufacturing

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

US pharma tariffs may start low and rise, risking drug shortages, higher costs, and pressure on generics amid reshoring push.

Tariffs on APIs and finished drugs could take effect as early as August 1, with accelerated investigations raising urgency for supply chain planning.

Manufacturing sites and a control site will work together in a hub-and-spoke model that has key differences from conventional manufacturing operations.

The new building will create 150 new jobs and expands total production area to nearly 12,000 square meters.

In contrast to earlier conferences in 2025, experts interviewed as part of the BIO conference in Boston did not come to a consensus about lasting impacts of recent changes in US government policy.

FUJIFILM representatives talked about the rebrand of the company’s life sciences businesses, partnerships with Regeneron and other companies, and the importance of having a presence at conferences like BIO 2025.

Bartłomiej Czubek, director of Business Development at Mabion, discussed what’s working, and the challenges set forth by what isn’t working, in the relationships built within the present biologics CDMO market.

The company’s successful completion of facility and equipment qualifications gives it another biologics manufacturing option alongside its United States campus in Morgan Hill, Calif.

BioPharm International® spoke with William O. Bullock, Senior VP, Economic and Statewide Development, North Carolina Biotechnology Center, about the growing biotechnology industry in North Carolina.

The agreement, which covers a period of five years, has been designed to offer a turnkey service to companies seeking faster time to market for ADCs and bioconjugates.

A continuous biomanufacturing platform can process higher/lower quantities of a drug as needed and allow manufacturers to respond to changing markets.

The increasing diversity and complexity of injectable drug products is driving innovation.

The facility is on the company’s Bedford, NH campus, where another existing building will be repurposed into a Development Center of Excellence.

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

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

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.

The poster presentations contain data highlighting the company’s role to date in developing non-replicating HSV-1 technology for use in neurology.

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

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.

Although automation is increasingly adopted in biomanufacturing, challenges remain in implementing it at the cell harvesting step.

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

The bio/pharma industry is evolving with intention, intelligence, and a growing sense of shared purpose.

The company’s intent is to establish Merck Wilmington Biotech as the future United States home for producing Keytruda for US patients.

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