Search results for "manufacturing"
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Biopharma Outsourcing Activities Update
Industry outsourcing more than ever
This year, if respondents follow through on their outsourcing plans, an even more influential dimension in the biopharmaceutical manufacturing industry can be ex…
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The Affordable Care Act's Impact on Innovation in Biopharma
The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.
The Affordable Care Act (ACA) has elicited intense national debate and sent biopharm…
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Predicting Progress in Protein Aggregation
As the development of biologic drugs based on antibodies and other protein/peptide molecules continues apace, the control and prevention of aggregation during manufacturing, downstream processing, for…
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Early Communication with Regulators is Essential for SMEs
The importance of early dialogue with regulators
Companies are encouraged to contact the agencies as early as possible during the drug-development stage to ensure that their manufacturing proces…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
Instead, the comparability exercise would be focused mainly on the manufacturing process, especially for more simple biosimilars.
“For structurally more simple biological medicinal products, a c…
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Evolution of the Monoclonal Antibody Purification Platform
This 31st article in the “Elements of Biopharmaceutical Production” series focuses on evolution of the purification platform for manufacturing of mAb therapeutics.
Traditional Mon…
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Navigating Emerging Markets: Middle East and North Africa
The pharmaceutical industry grows despite conflict in the Middle East.
The Middle East and North Africa have been rocked in recent years by upheaval ranging from moderate protest to full…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
The meeting was divided into different scientific sessions focusing on issues and possibilities around manufacturing, development and clinical use of plasma products in general. In addition, a poster …
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Essentials in Quality Risk Management
…uality attributes (CQAs) are defined and maintained from phase to phase during drug development and manufacturing and changes in drug-product formulation, definition, analytical method, and associate…
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The Future of Biopharma
These competitors are expected to compete on the basis of price; therefore, low manufacturing costs will be required. This low-cost requirement is driving many companies to seek out and adopt bioproce…