Search results for " biotechnology" in Articles / App Notes
Article
Quality by design for biotechnology products—part 1
This paper focuses on the factors to consider when applying the QbD concepts outlined in ICH Q8(R2), Q9, and Q10 to biotechnology products. The paper is intended to capture and reflect both the curren…
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Report from the 12th Plasma Product Biotechnology Forum
The feedback from the 12th Plasma Product Biotechnology meeting was overall incredibly positive with 64% of survey respondents classing the meeting as ‘Excellent’ and remaining respondents classified …
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Biotechnology Innovation and Growth in Israel
Moreover, according to Benny Zeevi, co-chairman of the Israel Advanced Technology Industries (IATI), Israel’s flourishing biotechnology industry is transitioning from a period of incubation to one of …
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Join the Plasma Product Biotechnology Meeting
The Plasma Product Biotechnology Conference Series has established a reputation as the key international forum for the presentation and discussion of topics relevant to the plasma manufacturing indust…
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Cytiva Opens Biotechnology Manufacturing Center in UK
GE Healthcare Opens Biotechnology Manufacturing Center in UK
Cytiva is opening a biotechnology manufacturing center at the Stevenage Bioscience Catalyst (SBC) Open Innovation Campus, in Stevenage…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Report from the Lanzarote meeting May 13th – 17th, 2013
Yet another well-attended and successful Plasma Product Biotechnology (PPB) meeting has been held. The meeting focu…
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Cytiva and Pall Corporation Investing 1.5 Billion USD Over Two Years to Meet Growing Demand for Biotechnology Solutions
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An ongoing strategic growth plan from Cytiva and Pall Corporation, part of the Danaher (NYSE: DHR) Corporation, will expand manufacturing capacity and services acros…
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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…