Manufacturing

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.

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

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.

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how geopolitical instability in Europe, and beyond, has impacted the bio/pharmaceutical supply chain.

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.

BioPharm International® spoke with Lun Xin, associate director at WuXi Biologics, about high-concentration biologics and some of the biggest challenges associated with their formulation.