Manufacturing

Mar 01, 2017
BioPharm International
As the November 2017 deadline nears, a surprising number of companies still don’t have a serialization plan in place. New programs aim to get them compliant in time.
Mar 01, 2017
BioPharm International
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
Mar 01, 2017
BioPharm International
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
Mar 01, 2017
BioPharm International
The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.
Feb 27, 2017
By BioPharm International Editors
The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.
Feb 27, 2017
By BioPharm International Editors
Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.
Feb 27, 2017
By BioPharm International Editors
Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.
Feb 23, 2017
By BioPharm International Editors
The companies have developed a Level 4 traceability solution to manage pharmaceutical regulatory requirements.
Feb 22, 2017
By BioPharm International Editors
CellGenix will add R&D, production, and warehouse space in Freiburg, Germany for GMP-grade raw materials for cell therapy, gene-therapy, and tissue-engineered products.
Feb 22, 2017
By BioPharm International Editors
FDA granted inotuzumab ozogamicin priority review and accepted its BLA for filing.
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