Manufacturing

The authors describe the development and validation of a highly sensitive point-of-use pressure decay test.

As pharmaceutical quality metrics evolve, they will need to incorporate more of the principles of operational excellence, says consultant Prabir Basu.

The co-located Pharma EXPO and PACK EXPO International presented technologies to protect products and people.

The two companies have entered into an agreement to provide Suzeken with access to AmerisourceBergen’s Cubixx inventory solution.

A pilot project, beginning in 2017, will support the development of biosimilars.

The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.

Univercells received a grant from the Bill & Melinda Gates Foundation for the development of a vaccine manufacturing platform.

Oxford Genetics received £1.61 million from Innovate UK to explore computational and synthetic biology approaches for optimized mammalian bioproduction.

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

BMS changes its US geographic footprint with R&D investments and closures.

At the American Society of Hematology Annual Meeting, Novartis and Kite Pharma both released results from early-phase clinical trials with CAR-T therapies.

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

Biosimilars may be the key to CMO growth.

Recipharm and Laccure AB signed a commercial collaboration for the manufacture and delivery of Laccure’s bacterial vaginosis treatment.

Airlocks, gowning rooms, and transition spaces have different uses and should be considered separately in cGMP pharmaceutical facility design.

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.

Wockhardt Limited received a warning letter from FDA for CGMP violations.

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.

Saneca Pharma has secured an agreement with Italian pharmaceutical company Menarini Group to deliver controlled-release pellets for one of its products.

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

New software platforms aim to help manufacturers implement connected technology and use data efficiently.

The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.

PDA’s first aging facilities survey suggests that post-approval changes play a major part in slowing pharmaceutical industry investment in new technology.

The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.

The new Boston laboratory offers advanced analytical testing services.

GS1 US published new guidelines in preparation for the serialization and traceability requirements associated with DSCSA.

PMMI, The Association for Packaging and Processing Technologies, released a report on trends opportunities in packaging of pharmaceuticals and medical devices that predicts increased spending on capital equipment for processing and packaging.