Manufacturing

Drug product approval from FDA follows previous approvals from European and Japanese authorities.

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.

The combined companies will provide research- and clinical-grade human immune cells, blood products, and related services.

Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.

Leistritz’s Twin Screw Extrusion Workshop, taking place Nov. 28–29, 2018 in Clifton and Somerville, NJ, will feature classroom sessions and extrusion demonstrations.

The companies will collaborate on the discovery, development, and commercialization of cell therapies for cancer.

Boehringer Ingelheim joins Oxford BioMedica, UK Cystic Fibrosis Gene Therapy Consortium, and Imperial Innovations to form a partnership for developing a new gene therapy to treat cystic fibrosis.

AuroMedics Pharma issued a voluntary, nationwide recall of two lots of piperacillin and tazobactam for injection, USP 3.375 g due to the presence of particulates identified as glass and silicone material.

Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework.

A process control system based on PAT can compensate for variations in particle size, resulting in more consistent coating thickness in a Wurster coating process.

Jean-Yves Balfin, product manager at Korsch AG, speaks to Pharmaceutical Technology about the ins and outs of multilayer tableting.

The company broke ground on its $200-million, 120,000-ft2 biomanufacturing plant in West Greenwich, RI.

The Flexmag 4050C Electromagnetic Flow Meter from Krohne is suited for biopharmaceutical applications including filtration processes, chromatography, or buffer and media preparation.

The C-Series air-operated double-diaphragm (AODD) pump from Almatec, part of PSG, a Dover company, is an alternative to similar plastic pumps and is suited for almost any pumping application that uses an oscillating pump.

Increasing dwell time can improve tablet production.

Modular manufacturing systems offer a less costly way to increase capacity while reducing time-to-market.

Development costs and time to market continue to put pressure on the biopharma industry, driving the need for innovation in methods and technologies.

The companies will work together to develop novel gamma delta T-cell receptor therapies in various cancers.

API can be mixed with silicone and other polymers to create drug-delivery combination products.

CMOs have been active over the past year in expanding their biologics production and capabilities.

This article provides a sampling of the latest investments, expansions, and acquisitions by small-molecule contract service providers.

Why shouldn’t biopharmaceutical manufacturers be able to leverage standardized construction practices to improve time to market?

A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.

Pfizer will invest nearly half a billion dollars to build a sterile injectable facility in Michigan.

The acquisition will place Cambrex into the finished dosage form CDMO market.

Fette Compacting’s FEC20 capsule filler for medium-sized batches is a smaller version of its FEC40 machine.

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.

Modern technologies, including Industry 4.0 and the Industrial Internet of Things, offer opportunities to increase biopharmaceutical manufacturing efficiency.