Patricia Van Arnum

The company expands to add process-development and clinical-manufacturing capabilities at its large-scale bulk biologics facility.

Company is notified of GMP violations at facility in Catania, Italy.

Maryland is the latest state to consider whether to include additional requirements for substitution of biological products.

Company considers investment in insulin cartridge-filling and insulin API manufacturing capacity in the US.

Company issues voluntary recall after learning of complaints of an uncharacteristic odor coming from Levoxyl bottles.

Novartis loses an appeal in seeking patent protection in India for its anticancer drug.

CROs are keeping pace with the increased globalization of the biopharmaceutical/pharmaceutical industry.

As biopharmaceutical/pharmaceutical companies increase their development of biologic-based drugs, companies providing analytical instrumentation and laboratory testing goods and services are, in turn, offering improved tools for biologic characterization, biomanufacturing, and related testing.

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.