Problems in scale-up of biotechnology production processes (Record no. 51312)

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control field MX-MdCICY
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control field 20250625160205.0
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Transcribing agency CICY
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Classification number (OCLC) (R) ; Classification number, CALL (RLIN) (NR) B-17149
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245 10 - TITLE STATEMENT
Title Problems in scale-up of biotechnology production processes
490 0# - SERIES STATEMENT
Volume/sequential designation Critical Reviews in Biotechnology, 13(3), p.195-253, 1993
520 3# - SUMMARY, ETC.
Summary, etc. The unique nature of biotechnology processes adds to the complexity and difficulty of scale-up. Successful scale-up means a shortened cycle to full-scale production, competitive advantage, and cost savings. The many pitfalls as well as actual and potential scale-up problems are reviewed. Emphasis is placed on covering all areas of concern in planning, executing, and documenting key studies. Needs in technology transfer are discussed and regulatory requirements are incorporated into scale-up needs. A review of the recent literature is coupled with actual case studies; problem avoidance is stressed. Problems in asepsis, in construction, and in validation are discussed and potential solutions given. Organizational problems are noted. Finally, checklists are given for project planning, for a safety audit, and for timely attainment of successful scale-up. Eighty-two references are included.
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Topical term or geographic name entry element BIOREACTOR
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Topical term or geographic name entry element AGITATION-AERATION
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Topical term or geographic name entry element STERILIZATION
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Topical term or geographic name entry element ASEPSIS
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Topical term or geographic name entry element VALIDATION
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Topical term or geographic name entry element CELL CULTURE
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Topical term or geographic name entry element FERMENTATION
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Topical term or geographic name entry element PROJECT PLANNING
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Topical term or geographic name entry element DOWNSTREAM PROCESSING
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Topical term or geographic name entry element CONTAINMENT
700 12 - ADDED ENTRY--PERSONAL NAME
Personal name Reisman, H. B.
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier <a href="https://drive.google.com/file/d/1pHpNt8YyV9EbH-HiZZSyfoCngqy7NspP/view?usp=drivesdk">https://drive.google.com/file/d/1pHpNt8YyV9EbH-HiZZSyfoCngqy7NspP/view?usp=drivesdk</a>
Public note Para ver el documento ingresa a Google con tu cuenta: @cicy.edu.mx
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Source of classification or shelving scheme Clasificación local
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  Clasificación local     Ref1 CICY CICY Documento préstamo interbibliotecario 25.06.2025   B-17149 25.06.2025 25.06.2025 Documentos solicitados