Dosage Forms

GlaxoSmithKline opened a new vaccines R&D center in Rockville, MD creating up to 200 new jobs.

Principles of dissolution testing, including method development and testing apparatus, are reviewed.

FDA and BARDA awarded a contract to Continuus Pharmaceuticals to develop an end-to-end continuous manufacturing process for solid-dosage drugs.

Quantitative and qualitative tools allow better understanding of mixing in a single-use bioprocessing system.

Hot-melt coating was used to develop taste-masked orally disintegrating granules of acetaminophen and caffeine.

Takeda will invest more than 100 million Euros to build a new manufacturing plant for its dengue vaccine candidate in Singen, Germany.

Catalent adds two softgel facilities and packaging capabilities with acquisition of Canada-based Accucaps.

Oxford Genetics has been awarded a grant to develop packaging cell lines for virus bioproduction and will work in collaboration with the University of Oxford to generate cell lines for the scalable manufacture of retrovirus and lentivirus vectors.

Avecia is adding drug substance capacity at its Milford, MA manufacturing site.

Research by agency scientists may help speed development of Zika virus vaccines.

Idifarma has announced a growth of more than 50% over the past two years. Revenue is expected to hit approximately EUR5.3 million in 2016, growing from EUR3.5 million in 2014.

German biotech ARTES and Iranian biopharma manufacturer BioSun will develop an HPV vaccine.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

Reliable, high-quality products require innovative analytics and production.

A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.

Shear-sensitive ingredients in a tableting formulation experience different conditions in a batch tumble blender than they would in a continuous paddle blender.

A dissolution method should have adequate discriminatory power to detect formulation changes that affect the dissolution rate of a drug product.

A variety of strategies have been employed to deliver proteins and peptides in improved parenteral formulations and/or via noninvasive routes.

Astellas will acquire Ganymed and its portfolio of ideal monoclonal antibody candidates.

The biosimilar pathway permits licensure based on less than full clinical data.

Oxford Genetics has secured a GBP1 million capital from investment group Mercia Technologies to support its growth strategy in delivering new services for cancer-fighting gene-therapy technologies.

The collaboration follows the signing of a cooperative research agreement between Sanofi Pasteur, Fiocruz, and WRAIR.

FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.

Catalent invests $34 million to add a 2 x 2000-L single-use bioreactor system and laboratory space in Madison, WI.

Horizon announces new bioproduction outlicense deal with an unnamed partner for a minimum value of £500,000.

HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.

WuXi AppTec’s new biomanufacturing facility is its third facility in the Philadelphia, PA Navy Yard.

Multiple inspection techniques facilitate the identification of particulate matter in vials as part of root-cause investigations and safety evaluations.

The Intelligent Control Inhaler is an intuitive, fully-integrated device delivering accurate doses of medication to patients, while providing on-screen instructions for use and feedback to the patient and healthcare provider via an app.

Novasep’s BioSC Lab chromatography is a flexible equipment that enables operations from one column up to six columns in batch, parallel batch, or continuous processing with all media and membrane types.