Search results for " biotechnology"
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Regulatory Challenges in the QbD Paradigm
Review and inspection responsibilities are shared between the Office of Pharmaceutical Science/Office of Biotechnology Products (OBP) and the Office of Compliance/Office of Manufacturing and Product Q…
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PDA's Technical Report for Biotech Cleaning Validation
49: Points to Consider for Biotechnology Cleaning Validation, well–designed laboratory-scale studies can be performed using design of experiments, and the data analyzed to understand the cleaning proc…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Ever-growing biotechnology pipelines have greatly increased demand for higher throughput, multi-product protein characterization methods. By taking a holistic approach to improving the analytical proc…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
ICH, Q5A (R1) Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, Step 5 version (1997).
10. FDA,…
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Setting Standards for Biotech Therapeutics in India
…, antibiotics [10], herbal [31], vaccine and immunosera for human use [5], insulin products [6], and biotechnology products [7]. IP 2014 also included 19 new radiopharmaceutical monographs and a gene…
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Bureaucratic Roadblocks Threaten Biopharma Growth
The good news is that some mature and emerging economies are making growing use of patent systems to facilitate biotechnology research and commercialization. The bad news is that a number of countries…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
Early biotechnology products in the US and Europe were characterized by low titers and low cell densities using various cell hosts (1, 2). Most companies had few recombinant products licensed or in de…
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Cell-free Expression Systems Pose Cell Culture Alternative
Lewis professor of Engineering and director of the Cornell Institute of Biotechnology, Cornell University; and Govind Rao, professor of Chemical, Biochemical, and Environmental Engineering and directo…
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A Look at the Affinity Chromatography Landscape
The new resin will be produced at Cytiva’s biotechnology manufacturing center at the Stevenage Bioscience Catalyst (SBC) Open Innovation Campus, in Stevenage, UK, which was opened in November 2018.
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Understanding Validation and Technical Transfer, Part I
In fact, it has been said that for biotechnology products, “The product is the process.” Traditional small-molecule drug products have well-defined chemical structures and can be analyzed to ensure co…