Manufacturing

The agency takes action against websites that illegally sell unapproved medications.

NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.

Lonza’s planned facility will be used to develop and manufacture viral gene therapies and virally modified cell therapies

BioSC Lab biochromatography system performs protein purification in batch and continuous modes.

The University of Pennsylvania announces that it will collaborate with WuXi AppTech to research and develop gene vectors derived from recombinant viruses.

Automation and disposables continue to reduce human error.

Contract service providers share insights on biopharma market developments and the implications of biosimilar drug approvals.

Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, cost of goods, and sustainability from the start.

The exclusive manufacturing collaboration will establish production for adeno-associated virus gene-therapy treatments incorporating REGENXBIO’s NAV Technology.

An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).

The Canadian Green Cross facility will produce intravenous immunoglobulin and albumin.

In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”

Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.

FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.

Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer.

This article reviews factors that affect protein stability at different steps of the product manufacturing process and strategies to minimize their impact on product quality.

Removal of microorganisms is crucial when working with biologics. Sterile filtration offers a reliable, safe, and effective way to ensure product integrity.

Meritech’s CleanTech 2000SCA Automated Handwashing System delivers a 12-second wash and rinse cycle that removes 99.98% of dangerous pathogens from bare skin and gloves.

Hamilton’s EasyFerm Bio biocompatible pH sensor is designed for CIP, sterilization up to 140 °C, autoclavable temperature, and a pressure range up to 6bar.

Experts attending the European Psychiatry Association Congress in Vienna say that Adasuve has made an impact in the treatment of agitation in patients suffering from schizophrenia or bipolar I disorder.

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.

Medicago's new production facility will make plant-based vaccines and therapeutics.

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

Alexion will construct a biologics facility in Ireland that is its first outside the US.