Manufacturing

IDT Biologika will provide fill/finish services of live-vectored virus products in clinical development through licensure.

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.

BASF announced that steamcrackers are slowly being restarted at the company’s plant in Ludwigshafen.

The new patented desiccant stoppers improve the opening of tablet tubes used to contain lozenges, effervescent, and chewable tablets.

Prefilled syringes for commercial supply of the etanercept biosimilar will be produced at Catalent’s Brussels facility in Belgium.

Oxford Genetics increased its laboratory space to 5700 sq. ft. with a move to a new location at Oxford Science Park.

A €15-million investment will be made over 2014-2016 in a biotech facility located in Tres Cantos, Spain

Meissner’s QuaDrum rigid outer containers for its single-use assemblies can be used with standard, access, or retaining lids.

Recipharm launched a showcase line to demonstrate the company’s new serialization solutions.

Marken announced the opening of a new depot and logistics operations center in Argentina.

The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.

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

A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.

GEA’s ConsiGma, which is a multipurpose continuous manufacturing platform, won the award for excellence in manufacturing technology and equipment at the 2016 CPhI Pharma Awards.

Pyclear Protection replaces the use of antimicrobial preservatives in multi-dose products without any change to the primary packaging and has no impact on the manufacturing process.

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.

Pharma Venture’s approach in tackling supply-chain, logistic, and distribution challenges in the MENA region was recognized at the CPhI Pharma Awards.

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.

The time and resources required to finalize post-approval changes may be preventing manufacturers from modernizing facilities, or even scouting for new technology.

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.

Pharmaceutical manufacturers and business partners are studying how Advanced Digital Ledger Technology might solve supply chain and other data transfer problems.

PaizaBio will add aseptic injectable production capacity in Hangzhou, China.

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

Designing loss-in-weight feeders for accurate and consistent refill is crucial to a continuous solid-dosage process.

Primary packaging and manufacturing technologies minimize product/package interaction, protect quality, support safe travel through the supply chain, and enhance performance at point of use.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.