The revisions to European Union (EU) Annex 1 set the stage for the future direction of the pharmaceutical/biotechnology industry. This document is one of the main EU regulatory guidelines for Risk Management and Contamination Control (Eudralex Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products) and also serves as the blueprint for the strategies and policies implemented by the many pharmaceutical/biotechnology companies in the United States (US), as US companies frequently consider the EU market.
Read Our Recent Blogs
Kymanox Acquires EU Based Anteris Medical and Anteris Helvetia
Leveraging the well-respected anteris brand and team, this acquisition extends Kymanox’s capabilities and geographic reach with a strong European presence
Friday, 03 February 2023
Morrisville, North Carolina, USA and Holzkirchen, Germany an...
Interview: Kymanox Executive Advisors Mathias Romacker, Fran DeGrazio & Paul Jansen
Kymanox Executive Advisors (KEAs) Mathias Romacker, Fran DeGrazio, and Paul Jansen sit down with Guy Furness to discuss what has driven Kymanox's rapid rise in the drug delivery space and what makes the consulting company's model so successful, as well...
Growing Happy Cells: Bioreactor Optimization
Biologics, including cell and gene therapies, have become a hot topic in the pharmaceutical industry as their therapeutic applications expand. Challenges of developing biologic drug products include scale-up for commercial manufacturing and production ...