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.

In this exclusive Drug Digest video, Deepak Bahl from Roquette and Jagruti Patel from Lonza look at strategies for accelerating early-stage development while reducing risk, approaches to speeding up timelines for complex formats without sacrificing quality, and maintaining a flexible CMC process that ensures quality.

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

The trade show is expected to draw 35,000 attendees to a show floor netting more than 1 million square feet.

The company will build a multi-billion-dollar drug manufacturing center in Virginia that will focus on chronic diseases, as well as facilities in California, Indiana, Maryland, Massachusetts, and Texas.

George Francis Tidmarsh, MD, PhD, founding co-director of Stanford’s Master of Translational Research and Applied Medicine program, has been appointed as the new director of the Center for Drug Evaluation and Research.

A structured, risk-based framework for pharmaceutical compounding that enhances quality, regulatory compliance, and process consistency.

The agency’s Executive Steering Group on Shortages and Safety of Medicinal Products has issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.

An ordered pharmaceutical compounding process for use in 503A pharmacies, 503B outsourcing facilities, pharmaceutical industry, and other applications.

The company is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial due to customer complaints of the wrong product being included in a carton.

The partnership was formed in September 2024 in response to increasing demand for aseptic filling technologies and processes.

The company is expanding its US manufacturing and R&D capabilities with a $1 billion investment by 2030.

The new building expands on the company’s supply chain solutions for biologics and temperature-sensitive pharmaceuticals.

Cambridge Healthcare Innovations says its dry powder inhaler engine, Quattrii, can deliver large volumes of biologic and mRNA molecules in a single inhalation.

The 12th edition of the European Pharmacopoeia will be an all-digital, redesigned, user-friendly issue.

Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling.

The new facility offers cleanroom packaging and high-sensitivity analytical testing.

Chrysalis lists among its partners early-stage biotechnology companies, contract research organizations, top-10 pharmaceutical firms, and various other life sciences stakeholders.

The agreement has been designed to offer a turnkey service to companies seeking faster time to market.

Most of the company’s new additions, if not already online, will be scheduled for commissioning, validation, or qualification before the fourth quarter of 2025.

Smart technologies, such as digital and laser printing, incorporated into manufacturing equipment are helping manufacturers align with sustainability goals, according to Sheikh Akbar Ali, general manager and head of Development and Technology for ACG Packaging Materials.

The company describes the compact system as ergonomically designed, providing precision dosing and production floor flexibility.

Jon Ellis and Simon Vanstone, PhD, go behind the headlines to explore the latest M&A activity and what tariffs and funding changes could mean for mRNA and beyond.

The new lab will be used to develop and scale innovations for the production of medicines and to help secure the supply chain.