Formulation and Drug Delivery

FDA Releases Guidance on GDUFA Self-Identification

September 22, 2016

The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.

Flexible Biomanufacturing Facility in Russia Built to Meet Local Demand

September 22, 2016

R-Pharm facility in Yaroslavl, Russia, is designed to produce biological drugs with GE Healthcare's FlexFactory manufacturing platform.

Aptar Stelmi Presents Alternative Coated Stopper for Sensitive Drugs

September 22, 2016

Aptar Stelmi will present PremiumCoat, an alternative coated stopper for sensitive drugs, at CPhI 2016.

Researchers Propose a Portable Biomolecular Manufacturing Method

September 22, 2016

Researchers from the Wyss Institute explain a potential method for transporting and producing temperature-sensitive pharmaceuticals at a reduced cost.

Genentech Wins ISPE’s 2016 Facility of the Year Award

September 21, 2016

Genentech’s biologics drug substance plant is the overall winner of the International Society for Pharmaceutical Engineering’s 2016 FOYA Awards.

GSK Announces Plans to Address Emerging Global Health Issues

September 20, 2016

The company said it has plans to address global health challenges including vaccines, antimicrobial resistance, and preparation for future pandemics.

GE Healthcare Invests in Ireland Biopharma Manufacturing Campus

September 19, 2016

GE Healthcare’s GE BioPark Cork will hold four KUBio manufacturing facilities; GE will also collaborate with NIBRT for biopharmaceutical training.

UCB Receives Positive EU CHMP Opinion for Cimzia AutoClicks Prefilled Pen

September 19, 2016

The autoinjector is based on core technology licensed from Bespak.

Merck KGaA Joins the DiViNe Project

September 14, 2016

The project aims to address challenges facing the development, manufacture, and delivery of vaccines.

UK Approves Glaucoma Drug Product, Delivered with Nemera’s Multidose Preservative-Free Eyedropper

September 14, 2016

The Novelia system has been approved as a packaging component and delivery system of multidose drug product formulated without preservatives.