Manufacturing

Benjamin McLeod and Sebastian Lykke Skafte Andersen go behind the headlines to examine the motivations behind recent M&A activity, tariff responses, and more.

Third-party ICMC certification verifies multi-modality manufacturing readiness, meeting US and EU standards for advanced genetic therapies.

The Hopewell, N.J., site adds scalable, end-to-end viral vector production with integrated quality systems to speed clinical and commercial gene therapy programs.

The newly launched facility is located in The Woodlands, Texas, and will produce plasmid DNA as well as strengthen biopharma supply chains.

Biopharma’s future depends on seamless integration of technology, expertise, and strategy.

Avantor's Jerry Keybl, senior vice-president, Biopharma Products and Strategy, highlights innovations in biomanufacturing and recalls his impressions of INTERPHEX 2025, held this past April.

Increasing efficiency and quality through effective application of advanced technologies is becoming predominant.

Advanced technology platforms optimize the efficiencies and sustainability of single-use bioreactors, setting the scene for the next evolutionary step in biomanufacturing.

The new spinning plant to be built in Nobeoka City, Miyazaki, Japan will produce hollow-fiber cellulose membranes, expanding production of the virus removal filters.

If action is not taken within 60 days, the White House said it would “deploy every tool in our arsenal” to improve drug pricing practices for American patients.

Smart technology, personalized medicine, and the customization of CDMO relationships are helping manufacturers meet shifts in client demand.

While little information is known about this particular case, its possible implications are far-reaching.

US pharma firms face higher drug costs, delayed launches, and compliance risks from proposed sectoral tariffs, prompting urgent supply chain reviews.

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.

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.