Manufacturing

Articles

Telstar reports that its Boreas, a new 86° ultra-low-temperature freezer, increases average performance by 20%.

New Ultra-Low-Temp Freezer Increases Cold-Storage Performance

Sean Milmo is a freelance writer based in Essex, UK.

The upcoming serialization deadline and the United Kingdom's departure from the European Union could result in supply bottlenecks. 

Tackling Medicine Shortages in Europe

Agnes Shanley is senior editor of Pharmaceutical Technology.

Alan Kennedy, executive director of TEAM UP, shared perspectives on Poseidon and ocean transport with Pharmaceutical Technology.

From Supply Chains to Supply Networks: Poseidon Aims to Redefine Pharma Cold-Chain Logistics

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.

Poseidon Takes on the Pharma Supply Chain

Minzhang Chen, PhD, is CEO of STA Pharmaceutical, a WuXi AppTec company.

Valdas Jurkauskas, PhD, is vice-president and head of Chemistry at Akebia Therapeutics. 

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.

Transition From Clinical to Commercial Supply Chain-Regulatory Starting Materials

The Multi-Chamber Blister System is a blister package that incorporates Amcor's SafeMix cold form laminate to transport vaccines and sensitive APIs without the need for cool storage.

Multi-Chamber Blister Package Protects Without Cool Storage

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

USB Data Logger for Temperature-Sensitive Products

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.

Managing Risk in a Complex Excipient Supply Chain

While more companies are embracing taggants, researchers are developing new technologies that will be extremely difficult to reproduce.

Anticounterfeiting: In Search of the Unhackable

The Tamper Evident Labeller from LSS Labelling Systems Scandinavia is compliant with the European Falsified Medicines Directive.