Supplier-Change Management for Drug-Product Manufacturers
November 22, 2013 - By: S. Jones, B. Trdina, C. Pullinger, K. Vermeulen, E. Flamm, A. Keusch, J. Goetz for BioPharm Inte
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating
Evolution of the Monoclonal Antibody Purification Platform
Monoclonal
November 22, 2013 - By: Anurag S. Rathore, Ranga Godavarti, Vijesh Kumar, Nihal Tugcu for BioPharm International
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Trends in Downstream Bioprocessing
November 1, 2013 - Eric Langer BioPharm International
Downstream processing involves the
State of Quality and Compliance in the Biopharmaceutical Industry
The late 1990s and earl
October 23, 2013 - Anastasia G. Lolas, Ian Uydess BioPharm International Magazine
Have FDA initiatives improved manufacturing quality?
FDA Seeks Metrics to Define Drug Quality
October 18, 2013 - Jill Wechsler, BioPharm International
Manufacturing standards are considered key to preventing drug recalls and shortages.
Critical dru
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Navigating Emerging Markets: Middle East and North Africa
October 13, 2013 - Jill E. Sackman, PhD , BioPharm International Magazine
The pharmaceutical industry grows despite conflict in the Middle East.
Operational Excellence: More Than Just Process Improvement
October 13, 2013 - Ian Uydess, Robert E. Spector, BioPharm International Magazine
By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.
Life-sciences companies
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Essentials in Establishing and Using Design Space
October 4, 2013 - Thomas A. Little, PhD BioPharm International
Knowledge of product or process acceptance criterion is crucial in design space.
Report from the Eighth International Plasma Product Biotechnology
October 3, 2013 - Cytiva
Biosimilars Development and Supply: How Complex Can the Process B
September 30, 2013 - Martin Van Trieste, BioPharm International Magazine
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
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