Pharmaceutical Technology Editors

Rentschler Fill Solutions and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.

Ingenza, in partnership with the University of Dundee and Drochaid Research Services, will work on a project to recycle CO2 emissions from bioprocessing plants to serve as feedstock and energy inputs.

The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.

Coperion will be presenting a new, innovative pneumatic conveying process for plastic pellets that consumes up to 35% less power and generates up to 98% less dust at Achema 2018. Fluidlift ecoblue enables manufacturers of plastic granulates to increase product quality while reducing specific power consumption.

The UK’s University of Sheffield opened a new chemical engineering teaching plant for continuous oral solid-dosage pharmaceuticals using GEA’s multipurpose platform.

Rommelag will showcase its single-use, flexible packaging system at Achema 2018.

Rommelag will showcase its blow-fill-seal technology that collectively offers container production, aseptic filling, and container closure.

Bayer received conditional approval from the Antitrust Division of the United States Department of Justice to acquire Monsanto in a deal worth $66 billion.

The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.

FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.

Bosch Packaging Technology’s capsule filling machine for small batches of hard capsules uses a fully automated, washable containment process.

The updated version of Schubert-Pharma’s Flowmodul unit for packing units into flowpacks features cleanability.

Bosch Packaging Technology will present its new modular freeze dryer at Achema 2018.

GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.

World Health Organization’s Ebola ring vaccination uses Merck & Co.’s investigational rVSV-ZEBOV vaccine to protect high-risk communities in the Democratic Republic of the Congo from Ebola.

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).

Glatt Ingenieurtechnik has added compact continuous agglomeration equipment and new control systems to its "modular plant engineering" portfolio.

Optima will also display the freeze dryer CS and the sterility test isolator STISO at the show.

The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.

GEA and Perceptive Engineering will collaborate to promote and deploy multivariate monitoring and advanced process control (APC) solutions for batch and continuous pharmaceutical process units.

Spectrum Pharmacy Products celebrated the one-year anniversary of its compounding education center, Spectrum Pharmacy Institute, which offers compounding training for pharmacists and pharmacy technicians.

In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.

WuXi Biologics will build a biologics manufacturing facility in Singapore that will use both fed-batch and continuous perfusion-based single-use bioreactors.

The agency issued guidance on over-the-counter topical drug products that address maximal usage trials.

The new drug offers rapid and sustained control of patients’ potassium levels.

Allergan will buy a potential depression treatment from Aptinyx.

The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support.

The company has leased and purchased facilities in the United States and Europe to expand its cell therapy pipeline.

Hapa addresses the topics of four-color printing on blister packages, serialization, and digitalization at Achema 2018.