Search results for "manufacturing" in Articles / App Notes
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
What role is QbD playing in continuous manufacturing programs?
It could be argued that the renewed interest in continuous manufacturing was pushed by QbD implementation, in particular that of Proce…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Characterization of multiple product batches is essential to demonstrate to the regulatory body that the manufacturer has control of the manufacturing process. This is achieved by analyzing a number o…
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
These approaches did not affect product quality and were effective for multiple cell lines and applicable for large-scale manufacturing.
Recombinant protein production in the biopharmaceutical …
Article
Biopharma Moves to Integrated, Single-Use, Downstream Processing
She notes that the adoption of pre-packed, limited-use chromatography in the industry has been particularly slow, even though the value proposition for early clinical phase manufacturing is clear (tim…
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Biopharma Takes a Nervous Glance Over Its Shoulder
Both R&D and manufacturing could shrink or shift to other countries if the business operating environment for the biopharmaceutical industry in the nation does not improve.
This prediction is t…
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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…