Manufacturing

The agency gives a limited reprieve to dispensers but requires other trading partners to provide product tracing information.

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

Australian company, Genea Biocells, will open a facility in San Diego, California for cell and culture-media manufacturing and R&D.

The divestment of Nimenrix and Mencevax was to satisfy regulatory clearances when GSK gained Novartis’ vaccines business in an asset swap in March 2015.

IDT Biologika acquired Aeras' vaccine manufacturing facility, and the companies will work together on tuberculosis vaccine development.

Novasep's new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.

Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.

apceth has completed a major GMP inspection for two medicinal products. The two cell and gene therapy products are now included in the company’s GMP manufacturing license according to §13 of the German Medicines Act (AMG).

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.

Monoclonal antibodies can facilitate the entry of radiopharmaceuticals into cells, David Scheinberg said at BIO 2015.

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.