Manufacturing

Stephen Wicks, PhD, is the scientific regulatory policy and intelligence officer of the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, Stephen.WICKS@edqm.eu. EDQM is a leading organization that protects public health and amongst other things is responsible for the European Pharmacopoeia.

Articles

The European Pharmacopoeia addresses the need for monographs for biologicals to keep pace with recent analytical technology advances.

Keeping Up with Biologics Advances

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

FDA Releases Guidance on CMC Changes for Biologics

This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.

Intertek Opens GMP Pharmaceutical Stability Storage Facility in Cambridge, UK

Medicago's new production facility will make plant-based vaccines and therapeutics.

Medicago Plans Vaccine Facility In Quebec City

AstraZeneca announces that it will invest $285 million in a new manufacturing facility in Sweden.

AstraZeneca Invests $285 Million in New Facility

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

Vaccine Patch Could Eliminate Traditional Protocol for Vaccine Delivery

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Ensuring the Quality of Biologicals

Agnes Shanley is senior editor of Pharmaceutical Technology.

Pharma APIs: It’s Still a Small World

Catalent’s Zydis technology will be used to develop thermo-stable and cold-chain independent vaccines.

Catalent Awarded Vaccine Research Grant

GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.

Manufacturing, Biologic Drugs