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The Resource Process monitoring and quality by design for biotechnology products, Neslihan DelaCruz, (electronic book)

Process monitoring and quality by design for biotechnology products, Neslihan DelaCruz, (electronic book)

Label
Process monitoring and quality by design for biotechnology products
Title
Process monitoring and quality by design for biotechnology products
Statement of responsibility
Neslihan DelaCruz
Creator
Subject
Language
eng
Summary
Traditional pharmaceutical development is an unwieldy process requiring extensive experimentation and long lead times before process scientists can fully understand the effect that process parameters such as pH, temperature, cell viability, or process yield may have on the product acceptability. Implementation of quality by design is a science-based approach that allows the operating ranges and the acceptance criteria to be established based on the impact on product quality attributes. During manufacturing, process monitoring becomes part of a continuous verification effort and statistical control limits can be used to signal potential trends or drifts in the process. Single manufacturing batches that are aberrant are readily identified. The melding of scientific understanding, information systems architecture, instrumentation, software, and personnel training provides a large return on investment by ensuring that the manufacturing process produces a consistent pharmaceutical product that meets acceptable release standards for human use
Member of
Cataloging source
CaBNvSL
http://library.link/vocab/creatorName
DelaCruz, Neslihan
Illustrations
illustrations
Index
no index present
Literary form
non fiction
Nature of contents
  • dictionaries
  • abstracts summaries
  • bibliography
Series statement
Biotechnology
Series volume
1
http://library.link/vocab/subjectName
  • Pharmaceutical biotechnology
  • Biological products
  • Pharmaceutical Preparations
  • Biotechnology
  • Quality Control
Target audience
  • adult
  • specialized
Label
Process monitoring and quality by design for biotechnology products, Neslihan DelaCruz, (electronic book)
Instantiates
Publication
Bibliography note
Includes bibliographical references (p. 27-28)
Color
multicolored
Contents
  • 6. Conclusion
  • 1. Introduction -- 2.
  • From the traditional development path to quality by design
  • 3.
  • Continuous process verification and process monitoring
  • 4.
  • Process monitoring and statistical control limits
  • 5.
  • Multivariate analysis: a mature state of statistical process monitoring
Dimensions
unknown
Extent
1 electronic text (ix, 28 p. : ill.)
File format
multiple file formats
Form of item
electronic
Isbn
9781615041152
Other physical details
digital file.
Reformatting quality
access
Specific material designation
remote
System details
System requirements: Adobe Acrobat reader
Label
Process monitoring and quality by design for biotechnology products, Neslihan DelaCruz, (electronic book)
Publication
Bibliography note
Includes bibliographical references (p. 27-28)
Color
multicolored
Contents
  • 6. Conclusion
  • 1. Introduction -- 2.
  • From the traditional development path to quality by design
  • 3.
  • Continuous process verification and process monitoring
  • 4.
  • Process monitoring and statistical control limits
  • 5.
  • Multivariate analysis: a mature state of statistical process monitoring
Dimensions
unknown
Extent
1 electronic text (ix, 28 p. : ill.)
File format
multiple file formats
Form of item
electronic
Isbn
9781615041152
Other physical details
digital file.
Reformatting quality
access
Specific material designation
remote
System details
System requirements: Adobe Acrobat reader

Library Locations

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