Formulation and Drug Delivery

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.

The Koolit Advanced PCM Gel from Cold Chain Technologies provides cold-temperature protection for drugs and vaccines during transport.

A PESU membrane is now available for Sartorius Stedim Biotech Sartocon benchtop and production-scale filtration assemblies.

The hospital received a five-year $5 million grant from CDC to survey for communicable diseases in children and evaluate vaccine effectiveness.

This article will equip the excipient vendor with an understanding of QbD from the perspective of the topical pharmaceutical product manufacturer.

Excipients play a crucial role in the manufacturing of solid-dosage forms and the performance of the finished drug product.

Understanding the components of a reference marketed pMDI is needed to develop a generic pMDI.

Tapemark, a full-service CDMO specializing in transdermal, oral thin film, and topical drug-delivery technologies, is exhibiting at CPhI.

Ravi Limaye gives an overview of the biosimilar industry and projects for 2020.

Alan Sheppard, Principal, Global Generics at IMS Health and CPhI expert panel member, discusses generic medicine opportunities in the 2016 CPhI Annual Industry Report.