Formulation and Drug Delivery

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.

The study in 48 healthy adults will assess the safety and immunogenicity of a prime-boost regime of two different intranasal doses of the RSV vaccine, SynGem.

The new facility will focus on formulation development, drug product analytical development, and quality control.

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 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.

Datwyler is channelling more than CHF 100 million into building a new plant in the US state of Delaware, which will be used to manufacture elastomer components for injectable drug-delivery systems.

A new study proposes a new way to potentially treat congenital diseases in utero.

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.

Capsugel’s intrinsically enteric capsule technology provides enteric protection and delayed release without a functional coating. Merck’s Parteck SRP 80 sustained-release excipient is well suited for direct compression.

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.

The OptiForm Solution Suite platform offers easy, simple, fast, and cost-effective approaches for both small and macromolecules in early development phases.

The winning entry was Merck’s Emprove program, which facilitates risk assessment and supplier qualification by providing instant, online access to regulatory and technical information on hundreds of products used in pharmaceutical and biopharmaceutical manufacturing.

Xellia added laboratory space and personnel in Zagreb, Croatia to work on anti-infective products that combat the antimicrobial resistance problem.