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Manufacturing

Jul 21, 2017
By BioPharm International Editors
Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.
Jul 19, 2017
By BioPharm International Editors
GSK plans to invest in several UK manufacturing sites and to close its Slough site in conjunction with the sale of the Horlicks brand manufactured in Slough.
Jul 18, 2017
By BioPharm International Editors
The addition of 20,000 sq. ft. of manufacturing and office space increases Avecia’s Milford, Ma, oligonucleotide capacity to 3.0 mol.
Jul 17, 2017
By BioPharm International Editors
Higher-flow peristaltic pumps from Watson-Marlow Fluid Technology Group are designed for upstream and downstream bioprocessing with single-use fluid path assemblies.
Jul 01, 2017
BioPharm International
Continuous processing of 100 g of monoclonal antibody in 24 hours has been demonstrated using lab-scale equipment.
Jul 01, 2017
BioPharm International
Perfusion processes can attractive for biologics drug manufacturing; however, obstacles remain.
Jul 01, 2017
BioPharm International
The authors present a shift toward more integrated purification processes.
Jul 01, 2017
BioPharm International
CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.
Jul 01, 2017
BioPharm International
The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
Jul 01, 2017
BioPharm International
This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
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