Search results for " sourcing"
Article
Setting Up Bioprocessing Systems for Digital Transformation
Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.
By Feliza Mirasol
The advancement of digit…
Article
Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
Article
Good Manufacturing Practices: Challenges with Compliance
WrightStudio/Stock.Adobe.com
The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
By Lauren Lavelle
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Article
Cell-Culture Advances Test Bioreactor Performance Models
The evolution of cell-culture technology is driving the need for improvements in modeling solutions.
By Cynthia A. Challener
Modeling and simulation are recognized to provide assistance i…
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.
By Feliza Mirasol
ARTMOIS/STOCK.ADOBE.COM
Biopharmaceutical manufactu…
Article
Supply Chain Challenges for Single-Use Systems
Pora (Pall): Sourcing and lead times have long been challenges for both suppliers and consumers, with some of the key pain points including lead times and an ever-changing and advancing industry.
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Article
Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important.
By Mostafa Eissa
The biopharmaceutical industry has witn…
Article
mAbs to Watch in 2016
By Randi Hernandez
Of the 45 new molecular entities and new therapeutic biological products approved by FDA in 2015, nine products were monoclonal antibodies (mAbs). And there may be many more o…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
By Leonard P. Freedman, Mark C. Gibson, Richard M. Neve
Irreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays and increased costs of …
Article
Best Practices in Qualification of Single-Use Systems
In addition, the author sincerely thanks the collaboration from Amgen’s Raw Materials & Devices, Supplier Quality Management, Global Strategic Sourcing, and Process Development, as well as major suppl…