Manufacturing

Articles

This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).

Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase Columns

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

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

Considering Single-Use Materials

Chris McNulty is director of Pharmaceutical/Biotech Sales at Sani-Matic, Inc.

Early planning for the integration of clean-in-place systems for equipment cleaning is key.

Cleaning Bioreactors and Fermenters with CIP Systems

The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.

Pharmacopeias Continue Harmonization Program

Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.

Pfizer Builds Biologics Clinical Manufacturing Facility in Massachusetts

The company will be exhibiting at the 2016 International Fuel Ethanol Workshop and Expo.

VAC-U-Max to Exhibit Industrial Vacuum Cleaning Equipment

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.

Alvotech Opens mAbs Biosimilar Facility in Iceland

Customized puresu single-use fluid path assemblies from Watson-Marlow Fluid Technology Group incorporate tubing and BioPure components and are supplied ready to use.

Single-Use Tube Assemblies Are Validated and Ready-to-Use

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

Effective harvesting and purification processes play an essential role in ensuring that biopharmaceutical manufacturing processes provide biologic drug substances with uniform and consistent properties.

Ensuring Biologic API Uniformity

Preheating pinch valves prevents drift in the volume of liquid dispensed.