Manufacturing

Bayer has appointed Cardinal Health as US-based contract manufacturer for Xofigo (radium Ra 223 dichloride) injection, and Cardinal Health will build a dedicated facility.

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

A global framework of standards enabling collaboration among industry stakeholders is needed to battle the increasing threat of counterfeit medicines.

New pharmaceutical packaging equipment includes advances in automation and efficient systems.

FDA funded projects at Rutgers' C-SOPS and at UMass Lowell to develop flow-sheet model algorithms for use in risk assessment, and start-up company Continuus Pharmaceuticals is making progress on their integrated system.

FDA drug approvals are up in 2014 with biologics drugs representing more than 25% of FDA approvals to date.

The multi-product biopharmaceutical manufacturing facility is scheduled to start up in 2017.

Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.

Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.

A new release of FactoryTalk Batch software from Rockwell Automation eases recipe creation and adds security.

US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.

On December 8, Pfizer announced that it will establish a research program in gene therapy, and collaborate with Spark Therapeutics in Philadelphia, to develop potential gene therapy treatments for hemophilia.

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.

The final article of this series will look at the last two steps of the PharmaCare seven-step process?Lubricate and Store.

No evidence that Fluad vaccine caused deaths in Italy, says EMA.

Optel Vision, a Canadian company specializing in track-and-trace and vision inspection solutions for manufacturing industries, announced that its facility in Limerick, Ireland is now opened to serve customers across Europe.

CDMO Vetter announced the addition of a new flexible serialization service, introduced in response to stricter packaging regulations calling for drugs to be serialized as a means to fight counterfeits.

Sartorius Stedim Biotech’s BIOSTAT A is a compact bioreactor and fermenter with accessible peristaltic pumps, probe ports, and supply connections.

Indian manufacturers are moving towards high-value, low-volume work, with complex chemistry and intellectual property challenges.

Dual sourcing is one of many possible solutions to securing the supply chain.

Solving the problem of tablet spots or specks involves prevention and thorough investigation.

Outsourcing is taking on a greater role in the biopharmaceutical manufacturing industry.

Dalton Pharma Services announced it was awarded funding from ISTPCanada for its project to develop vaccines for respiratory syncytial virus and parainfluenza type 3.

The Baxter recall in the US of one lot of highly concentrated potassium chloride is due to a mislabeled overpouch.

The Singapore API facility will be operational by 2016.

The more than $200 million project will increase production capacity at the facility to support AstraZeneca':s maturing pipeline.

GSK Australia's Boronia site will install next-generation blow-fill-seal machinery for aseptic filling.

Over the last three weeks, we have been looking at each step and the benefit of adopting the process. This week, we look at Step 4, Measure.

New child-resistant packaging designs meet regulatory requirements, and consumer research into child-resistant closures continues.

Although the source of spots and specks on tablets is sometimes difficult to identify, following good maintenance and manufacturing practices can help solve or even prevent the problem.