Manufacturing

Lower costs, fewer opportunities for temperature excursions, and a smaller carbon footprint are making ocean transport more attractive for pharmaceuticals. Poseidon, a new collaborative pharma initiative, seeks to leverage benefits.

Stability testing on APIs/finished drug product helps define optimal drug packaging for shelf-life storage.

Johnson Matthey has manufactured a new Gusev catalyst for ester hydrogenation using technology that promotes sustainability and improved reactivity and selectivity, according to the company.

Tableting instruments (i.e., compaction simulators) that simulate high-speed presses can be used in a quality-by-design (QbD) approach to perform in-depth material characterization and direct scale-up.

The authors discuss expectations of regulators on the selection of drug substance regulatory starting materials (RSM) and the justification of their designation in the pharmaceutical supply chain, the scope of the RSMs' presentation required in regulatory filings, and how to mitigate and prepare for "push backs" in the event of a major objection to the sponsor's RSM designation.

Can an Irish analytics company and its CEO bring pharma closer to 21st-century practice?

Materials used in the seals of split butterfly valves for aseptic pharmaceutical manufacturing should be chosen carefully.

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

An architect's evaluation early in a pharmaceutical facility relocation and design process can help identify potential problems.

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

Automation systems, vehicles, and robots improve efficiency of transporting materials and finished goods in pharmaceutical warehouses.

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

A new suite for the encapsulation of highly potent drugs will be added.

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.

FDA approves Vertex's cystic fibrosis drug, Symdeko (tezacaftor/ivacaftor and ivacaftor), which is made using a continuous manufacturing process.

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.

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

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.

FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.