Drug Development

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The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.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

Application for Sirdupla Uniformity of Delivered Dose Methodology

Armin Gerhardt, associate professor of Pharmaceutical Science, Concordia University Wisconsin School of Pharmacy, discusses the effects of moisture on product quality and how to achieve good control of moisture during pharmaceutical manufacturing operations.

The author looks at EUCAST’s role in tackling the spread of antimicrobial resistance, by creating definitions for a global consensus.

Immuno-oncology drugs are demonstrating patient benefits, but growing resistance to the high cost has implications for patients, market access, and manufacturers.

The agency publishes draft guidance on assay development and validation for immunogenicity testing.

Shire announces plans to build a flexible biopharmaceutical manufacturing facility in County Meath, Ireland.

FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.

FDA approved an update in the manufacturing of Prezista (darunavir) using a continuous manufacturing line at Janssen Supply Chain’s facility in Puerto Rico.

Cornell researchers reveal that an existing FDA-approved drug can facilitate the delivery of other large molecules across the blood-brain barrier.

Kollicoat MAE 100-55 from BASF can be used as a direct substitute in commercial enteric pharmaceutical formulations.

Transferring the manufacturing of a drug from one scale to another or between manufacturing sites presents both technical and business challenges.

Pharmaceutical Technology spoke with Bill Randolph, vice-president, Technical Services, Janssen Supply Chain, about some of the considerations for technology transfer of a continuous, solid-dosage manufacturing process and what he sees as the outlook for continuous manufacturing.

Manufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.

A global API marketplace increases the burden of supply chain monitoring for drug companies.