Manufacturing

Jul 21, 2015
Pharmaceutical Technology
This article provides an overview of three focal points of both Annex 11 and 21 CFR Part 11, including: • System Controls • Validation • Archiving
Jul 20, 2015
By BioPharm International Editors
Biogen will take ownership of Eisai's Research Triangle Park manufacturing campus and will manufacture both oral solid-dose and parenteral drugs for Eisai.
Jul 20, 2015
By BioPharm International Editors
The $19.7 million contract will assist Emergent with the development of cGMP lots of three Ebola mAbs.
Jul 19, 2015
By BioPharm International Editors
Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.
Jul 15, 2015
By BioPharm International Editors
Sanofi's new business-unit structure focuses on growth drivers.
Jul 13, 2015
By BioPharm International Editors
FDA released news of the ban of Emcure’s Hinjewadi manufacturing plant after it determined the plant did not meet basic quality standards.
Jul 06, 2015
By BioPharm International Editors
The European Pharmacopoeia has incorporated new provisions to encourage the use of in-process quality control methods.
Jul 05, 2015
By BioPharm International Editors
Biogen plans to build a biologics manufacturing plant in northwest Switzerland using next-generation technologies to create efficiency and sustainability.
Jul 01, 2015
By BioPharm International Editors
The addition of a new manufacturing line at Lonza’s Portsmouth, NH site enables Alexion to add dedicated product supply for 10 years.
Jun 30, 2015
BioPharm International
The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.