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  1. AU="Manning, Shane"
  2. AU="Hizir, Zoheir"
  3. AU="Merrell, Allyson J"
  4. AU="Marie I. Samanovic"
  5. AU="Journeaux, Alexandre"
  6. AU="Cao, Mei Juan"
  7. AU="Wang, Hua-Yu"
  8. AU="Posner, Clara"
  9. AU="Gomes Da Silva, G"
  10. AU="Thoma, Tizia"
  11. AU="Liu, Huixing"
  12. AU="Mita-Mendoza, Neida K"
  13. AU="Anderson, Richard C E"
  14. AU="Garcia, Paula"
  15. AU="Soumya Nayak"

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  1. Artikel ; Online: Multiproduct Resin Reuse for Clinical and Commercial Manufacturing-Methodology and Acceptance Criteria.

    Sharnez, Rizwan / Doares, Steve / Manning, Shane / Mehta, Krunal / Mahajan, Ekta / To, Angela / Daniels, William / Glynn, Judy / Dhamane, Sagar / Wen, Xiaona / Wang, Yunjuan / Gour, Pankaj / Guenther, Constanze / Foley, Derek / Hayes, Ronan / Mott, Adam / Prabhu, Sunil / Tavalsky, Dawn / Hendershot, Michael /
    Haas, David / Hesslein, Ashley / Schuelke, Norbert / Tjandra, Hendri

    PDA journal of pharmaceutical science and technology

    2018  Band 72, Heft 6, Seite(n) 584–598

    Abstract: Chromatography resins used for purifying biopharmaceuticals are generally dedicated to a single product. In good manufacturing practice (GMP) facilities that manufacture a limited amount of any particular product, this practice can result in the resin ... ...

    Abstract Chromatography resins used for purifying biopharmaceuticals are generally dedicated to a single product. In good manufacturing practice (GMP) facilities that manufacture a limited amount of any particular product, this practice can result in the resin being used for a fraction of its useful life. A methodology for extending resin reuse to multiple products is described. With this methodology, resin and column performance, product carryover, and cleaning effectiveness are continually monitored to ensure that product quality is not affected by multiproduct resin reuse (MRR).
    Mesh-Begriff(e) Biological Products/standards ; Chromatography/methods ; Drug Industry/methods ; Equipment Reuse ; Recombinant Proteins/standards ; Technology, Pharmaceutical/methods ; Viruses/isolation & purification
    Chemische Substanzen Biological Products ; Recombinant Proteins
    Sprache Englisch
    Erscheinungsdatum 2018-07-20
    Erscheinungsland United States
    Dokumenttyp Journal Article
    ZDB-ID 1205009-x
    ISSN 1948-2124 ; 0277-3406 ; 1076-397X ; 0279-7976 ; 1079-7440
    ISSN (online) 1948-2124
    ISSN 0277-3406 ; 1076-397X ; 0279-7976 ; 1079-7440
    DOI 10.5731/pdajpst.2016.007245
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel: A compression force comparison study among three staple fixation systems.

    Shibuya, Naohiro / Manning, Shane N / Meszaros, Amanda / Budny, Adam M / Malay, D Scot / Yu, Gerard V

    The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons

    2007  Band 46, Heft 1, Seite(n) 7–15

    Abstract: Traditional staples have recently been redesigned with both new materials and engineering techniques to facilitate interfragmentary compression in theory, resulting in greater friction between bone fragments to counteract shearing forces. In the current ... ...

    Abstract Traditional staples have recently been redesigned with both new materials and engineering techniques to facilitate interfragmentary compression in theory, resulting in greater friction between bone fragments to counteract shearing forces. In the current study, the biomechanical properties of 3 different staples were investigated. The interfacial force at 2 different sites within a calcaneal bone model was measured after insertion and activation of the OSStaple, the UNI-CLIP, and the Smith and Nephew Standard Large Staple after precompression with the SYNTHES Small Distractor. Additionally, the ability of each staple to maintain compression over a short period of time was investigated. In the current bench study, the OSStaple consistently generated the greatest and most uniform compression across the bone model osteotomy and was also capable of sustaining the compression over the duration of all of the trials.
    Mesh-Begriff(e) Animals ; Biomechanical Phenomena ; Humans ; Models, Anatomic ; Osteotomy/methods ; Pressure ; Sheep ; Sutures/standards
    Sprache Englisch
    Erscheinungsdatum 2007-01
    Erscheinungsland United States
    Dokumenttyp Comparative Study ; Journal Article
    ZDB-ID 1146972-9
    ISSN 1067-2516
    ISSN 1067-2516
    DOI 10.1053/j.jfas.2006.09.008
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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