Drug Development

A new 20,000-L microbial biologics facility in Ireland will be operational by 2018 for Fujifilm Diosynth's contract development and manufacturing customers.

The agency published a report on fostering the development of advanced therapy medicinal products.

FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.

Process analytical technology paved the way for continuous manufacturing.

Industry experts discuss the benefits and challenges of using single-use systems in pharmaceutical manufacturing.

Application of flow chemistry for small-molecule API synthesis continues to expand thanks to research efforts.

Experts discuss the key considerations in the development of an autoinjector.

The authors evaluated the performance and robustness of controlled-release tablets made with HPMC blends of unimodal and bimodal molecular weight distribution.

This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.

As the battle for ownership over the use of CRISPR to edit DNA heats up, some of the CRISPR pioneers refocus their efforts to demonstrate the technology’s applications for editing RNA.

The company expanded its topicals capacity with an investment in the Becomix RW30 model homogenizer.

The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.

PharmTech sat down with an intellectual property lawyer to examine how companies are protected when they engage in activities where sharing of trade secrets must occur.

Xellia, a generic anti-infective drug manufacturing company, is constructing a laboratory services building at its manufacturing site in Budapest, Hungary.

W.R. Grace & Co. will sell its chromatography product lines, which includes chromatography instruments, columns, and other related products.

A new study in Nature Communications explores how to remove the bulk of the soaps that are added to injectables to make hydrophobic drugs more soluble.

A US government report on advanced manufacturing promotes continuous manufacturing of pharmaceuticals, which has had recent commercial success but faces challenges for widespread adoption.

The company’s method reduces the time required to crystallize antibodies from weeks to one day.

Electrophilic and other reactive compounds, and their precursors, must be measured and removed to ensure patient safety.

Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing

AMRI’s acquisition of Euticals expands its API development and manufacturing business.

The production of antibody-drug conjugates requires biopharmaceutical and chemical manufacturing, and conjugation capabilities.

Safe handling of HPAPIs requires determining exposure potential and selecting appro-priate containment strategies.

Bioprocess operations-from cell line selection to final filtration-can influence the consistency and purity of biologic drug substances.

Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.