Manufacturing

Biologic new molecular entities (NMEs) accounted for 26% of total NME approvals in 2017.

The contract development and manufacturing organization has entered it first manufacturing contract worth $148 million for its recently completed Plant 3 facility.

The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.

The company aims to add the additional analytical services in the European Union throughout 2018.

The new training center, the Jefferson Institute for Bioprocessing, will prepare engineering students and industry professionals for the field of biologics manufacturing.

Avid Bioservices will provide commercial manufacture of an enzyme replacement therapy by Roivant Sciences' Enzyvant subsidiary.

The agreement follows the recent opening of WuXi STA's oligonucleotide R&D labs in China and the US.

The companies have partnered to develop and commercialize vectorized antibodies against tau for Alzheimer's and other neurodegenerative diseases.

The study suggests that circumventing evolution in cell factories can enable the commercialization of new biobased chemicals to large-scale.

The company has expanded its single-use manufacturing capabilities at its facility in Fermoy, Ireland.

Fluarix Tetra has been approved for use in children aged six months and above.

Ompi EZ-fill vials and Daikyo Seiko PLASCAP press-fit closures are a confirmed product set for use with Vanrx Pharmasystems' Aseptic Filling Workcells.

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.

Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.

Honeywell offers an augmented/virtual reality approach to train the industrial workforce.

The companies have been awarded a collaborative grant of £1.9 million (US$2.6 million) from Innovate UK.

Amgen plans to invest approximately $300 million in a new biomanufacturing plant in the United States.

Shire will receive exclusive license to develop and commercialize AB Biosciences' pan receptor interacting molecule program for autoimmune and inflammatory diseases.

A collaboration between The Centre for Process Innovation and The Roslin Institute aims to develop commercially viable and scalable methods of producing biologics using transgenic animals.

The Flexicon PF7 peristaltic tabletop aseptic liquid-filling machine from Watson-Marlow Fluid Technology Group is suitable for GMP-regulated biotechnology and pharmaceutical operations.

LogTag has added two new devices to its temperature data logger series.

Layout and supply details must be considered when implementing a fully disposable biopharmaceutical manufacturing process.

As closure integrity testing moves from a probabilistic to a deterministic basis, designs are promoting improved control and reduced operator contact.

Frustrated with high costs and drug shortages, hospitals adopt a DIY approach.

Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.

Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.

BioPharm International asked Andrew Bulpin, head of Process Solutions at MilliporeSigma, about the end-of-life options for disposable components of biopharmaceutical single-use systems.

The new Acquity Arc Bio System by Waters is specifically engineered to enable efficient transfer and improvement of bioseparation analytical methods.

A manufacturing disruption has led to an EpiPen shortage in Canada, which currently has no alternative auto-injectors available on the market.

The contract development and manufacturing organization has invested £30-million (US$42 million) at its Dundalk, Ireland site to offer expanded clinical trial services.