Search results for "manufacturing"
Article
Improving Process-Scale Chromatography
“Protein A enables a platform process for mAbs, thus enabling higher throughput of projects through process development and manufacturing,” she says.
Alternatives to Protein A chromatography are a…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
To be successful, however, the lead partner will need an understanding of biomanufacturing facility design, engineering, qualification, and validation, as well as the operational aspects of combining …
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The Metrics of Quality Culture
Conclusion
When establishing a metrics program, companies should evaluate numerous data input points including, but not limited to, product-quality attributes, manufacturing site performance, peop…
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Fluid Handling in Biopharma Facilities
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling and storage of fluids is essential to limit the possibility of contamination. Facili…
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Biosimilars Will Bring Significant Litigation and Patent Challenges
In that instance between Sandoz and Amgen, Sandoz did not disclose its manufacturing processes and FDA application to Amgen, the patent holder for Neupogen (filgrastim). A California judge ruled, howe…
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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 …
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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…