Manufacturing

Articles

Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.

Evonik Birmingham Laboratories Receives Renewal of EU GMP Certification

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?

Parenteral Advisory: Outmoded Fill/Finish Technology

Fresenius Kabi will add to its generic, sterile injectable manufacturing at its Melrose Park, Illinois site.

Fresenius Kabi Expands US Sterile Injectables Capacity

The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines

Designing Flexible Aseptic Containment Systems

A technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.

Evaluating Technology and Innovation in Biopharmaceutical Manufacturing

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

PharmTech’s 2016 survey shows general satisfaction with existing solid-dose and parenteral manufacturing equipment, and slow adoption of continuous manufacturing processes.

Measuring Equipment and Manufacturing Trends

David Deere is the chief commercialization officer for PaizaBio, a US-based contract manufacturing organization and consulting group with in-country aseptic fill-and-finish operations in Hangzhou, China. Deere is a veteran global pharmaceutical executive whose career path includes Valeant Pharmaceuticals International, F. Hoffman-La Roche and Genentech.

Quality, innovation, and new approval pathways open drug development options for the Chinese market, including injectable contract manufacturing.

Regulatory Reform in China Creates Opportunities

Fintan Weston is manufacturing director at Symbiosis Pharmaceutical Services.

While isolators may offer advantages in high-speed commercial manufacturing lines, RABS continues to be a flexible alternative solution for small-scale production of drugs for clinical use.

Debating the Role of RABS and Isolators in Aseptic Manufacturing

The company voluntarily recalls all lots of lyophilized HCG and sermorelin.

Talon Compounding Pharmacy Issues Recall

Gamma-stable fluoropolymers are an alternative material for single-use bags and assemblies in biopharmaceutical manufacturing.

Aseptic/Sterile Processing