APIs and Excipients

Removing Troublesome Solubilizing Excipients from Injectables

May 19, 2016

PTSM: Pharmaceutical Technology Sourcing and Management

A new study in Nature Communications explores how to remove the bulk of the soaps that are added to injectables to make hydrophobic drugs more soluble.

Measuring and Removing Genotoxic Impurities

May 15, 2016

Electrophilic and other reactive compounds, and their precursors, must be measured and removed to ensure patient safety.

AMRI Adds Custom API Capabilities

May 11, 2016

AMRI’s acquisition of Euticals expands its API development and manufacturing business.

PTSM: Pharmaceutical Technology Sourcing and Management

ADCs Challenge Manufacturers’ Skill Sets

May 04, 2016

The production of antibody-drug conjugates requires biopharmaceutical and chemical manufacturing, and conjugation capabilities.

Choosing Containment Strategies For Highly Potent APIs

May 02, 2016

Safe handling of HPAPIs requires determining exposure potential and selecting appro-priate containment strategies.

Upstream and Downstream Operations Can Impact Biologic API Uniformity

May 02, 2016

Bioprocess operations-from cell line selection to final filtration-can influence the consistency and purity of biologic drug substances.

Shire Builds Biologics Manufacturing Campus in Ireland

April 18, 2016

Shire announces plans to build a flexible biopharmaceutical manufacturing facility in County Meath, Ireland.

BASF Extends Kollicoat Excipient Line

April 04, 2016

Kollicoat MAE 100-55 from BASF can be used as a direct substitute in commercial enteric pharmaceutical formulations.

Conjugation Chemistry with Highly Potent Compounds

April 02, 2016

Manufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.

More Outsourcing? More Monitoring.

April 02, 2016

A global API marketplace increases the burden of supply chain monitoring for drug companies.