Drug Development

Articles

The project involves installation of a small-scale pressured agitated nutsche filter dryer in glass, integrated in a high-containment isolator to achieve an occupational exposure limit of less than 1 microgram per meter cube, 8-hour time weighted average.

Powder Systems Limited Installs High-Containment Filter Dryer in Australian API Manufacturing Plant

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

The vaccine candidate has also won a Priority Medicines (PRIME) status from EMA.

Merck Receives Breakthrough Therapy Designation for Ebola Vaccine

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Gamma-stable fluoropolymers are an alternative material for single-use bags and assemblies in biopharmaceutical manufacturing.

Considering Single-Use Materials

The collaboration will focus on the investigational candidate JTX-2011 and up to four other early-stage programs in immune-oncology.

Celgene Partners with Jounce Therapeutics for Immunotherapy Development

The antisense drug will be the first in the companies’ joint development deal for medications to treat autoimmune disorders of the gastrointestinal tract.

Ionis Pharmaceuticals Licenses Oral RNA-based Therapeutic to Janssen

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

SmithKline Beecham Gets Warned for Contamination

A new study examines the oral delivery of protein drugs in plant cells and hypothesizes that the cold storage and transportation of biologics could someday be eliminated.

Are Oral Peptide Drugs on the Horizon?

FDA reviewers have found that Sandoz's GP2015, a biosimilar version of Amgen's Enbrel, is highly similar to the original product in terms of purity, safety, and potency.

Sandoz's Biosimilar to Enbrel Gets FDA Support Ahead of Panel

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.

Federal Court Weighs in on Biosimilar Patent Dance

The assay will provide information on biosimilar comparability.

Formulation and Drug Delivery