Aseptic/Sterile Processing

AMRI Acquires Two Aptuit Facilities

January 09, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

The acquisition of Aptuit's Glasgow, UK and Indiana, US facilities will add sterile injectable formulation development and expand AMRI's analytical services capabilities.

CMOs Target Parenteral Drug Development Needs Both Large and Small

August 01, 2014

Representatives of contract service organizations that specialize in parenteral drug development and manufacturing describe the evolving trends.

Compounding Pharmacy Issues Recall, But Challenges FDA Decision

July 22, 2014

Unique Pharmaceuticals has issued a voluntary recall of sterile compounded preparations, but aired concerns about FDA?s recall demand.

Blow-fill-seal Technology Advances in Aseptic Filling Applications

June 18, 2014

Equipment and Processing Report

New advanced aseptic manufacturing technologies are available for filling liquid pharmaceuticals, including biologics.

Potential Benefits Drive Interest in Continuous Manufacturing

May 15, 2014

Players across the biologics value chain are attracted by the advantages of continuous biopharmaceutical manufacturing.

Continuous Bioprocessing Challenges

May 15, 2014

What challenges do biopharmaceutical manufacturers face when deciding to move from a fed batch process to a continuous process?

Achieving and Maintaining Compliance Using Continuous Monitoring Systems

May 15, 2014

Challenges encountered when implementing a continuous monitoring system are reviewed.

Optimizing the Sterilization of Liquids in Sealed Containers

May 15, 2014

sterilization approach-cycles controlled by differential pressure-is described.

Determining Protein Oxidation Induced During Fill-Finish Operations

May 15, 2014

The effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.

Single-Use Technology in Parenteral Fill/Finish

May 15, 2014

Application of single-use technology in a parenteral facility for syringe filling.