Rezultati

Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation od Hemlata Patil, Roshan V. Tiwari, Michael A. Repka

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Improvement of bioprocess monitoring: development of novel concepts od Franz Clementschitsch, Karl Bayer

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Development of a quantitative mass spectrometry multi-attribute method for characterization, quality control testing and disposition of biologics od Richard S. Rogers, Nancy S. Nightlinger, Brittney Livingston, Phil C Campbell, Robert W. Bailey, Alain Balland

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Determination of End Point of Primary Drying in Freeze-Drying Process Control od Sajal M. Patel, Takayuki Doen, Michael J. Pikal

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Understanding Pharmaceutical Quality by Design od Lawrence X. Yu, Gregory E. Amidon, Mansoor A. Khan, Stephen W. Hoag, James E. Polli, G. K. Raju, Janet Woodcock

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Human cell culture process capability: a comparison of manual and automated production od Yang Liu, Paul Hourd, Amit Chandra, David Williams

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Raman spectroscopy in pharmaceutical product design od Amrit Paudel, Dhara Raijada, Jukka Rantanen

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A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms od Michael Leane, Kendal Pitt, Gavin Reynolds

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Real-time assessment of critical quality attributes of a continuous granulation process od Margot Fonteyne, Jurgen Vercruysse, Damián Córdoba-Díaz, Delphine Gildemyn, Chris Vervaet, Jean Paul Remon, Thomas De Beer

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Process Analytical Technology for continuous manufacturing of solid-dosage forms od Margot Fonteyne, Jurgen Vercruysse, Fien De Leersnyder, B. Van Snick, Chris Vervaet, Jean Paul Remon, Thomas De Beer

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Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes od Thomas De Beer, A. Burggraeve, Margot Fonteyne, Lien Saerens, Jean Paul Remon, Chris Vervaet

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Process control in cell culture technology using dielectric spectroscopy od C. Justice, Alexander Brix, Denise Freimark, Matthias Kraume, Peter H. Pfromm, B. Eichenmueller, Peter Czermak

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Evaluation of manometric temperature measurement, a process analytical technology tool for freeze-drying: Part I, product temperature measurement od Xiaolin Tang, Steven L. Nail, Michael J. Pikal

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Continuous downstream processing for high value biological products: A Review od Andrew L. Zydney

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Rapid characterization and quality control of complex cell culture media solutions using raman spectroscopy and chemometrics od Boyan Li, Paul W. Ryan, Bryan Ray, Kirk J. Leister, Narayana M. S. Sirimuthu, Alan G. Ryder

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Quick generation of Raman spectroscopy based in-process glucose control to influence biopharmaceutical protein product quality during mammalian cell culture od Brandon Berry, Terrence M. Dobrowsky, Rebecca C. Timson, Rashmi Kshirsagar, Thomas Ryll, Kelly Wiltberger

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Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing od Karen A. Esmonde‐White, Maryann Cuellar, Carsten Uerpmann, Bruno Lenain, Ian R. Lewis

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Application of quality by design in the current drug development od Lan Zhang, Shirui Mao

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Investigation of the interactions of critical scale-up parameters (pH, pO2 and pCO2) on CHO batch performance and critical quality attributes od Matthias Brunner, Jens Fricke, Paul Kröll, Christoph Herwig

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Advances in downstream processing of biologics – Spectroscopy: An emerging process analytical technology od Matthias Rüdt, Till Briskot, Jürgen Hubbuch

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