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Leader |
LDR
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nam1i 00 |
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Control # |
1
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201011BTY001 |
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Control # Id |
3
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MOCL |
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Date |
5
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20221118121003.0 |
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Linking |
6
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m eo d |
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Phy Descr |
7
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cr cn |||m|||a |
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Fixed Data |
8
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101111s2010 caua foab 000 0 eng d |
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ISBN |
20
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$a9781615041152 (electronic bk.) |
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ISBN |
20
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$z9781615041145 (pbk.) |
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Std Rec No. |
24
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7 |
$a10.4199/C00019ED1V01Y201011BTY001$2doi |
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Local Ctrl # |
35
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$a(CaBNVSL)gtp00544555 |
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Local Ctrl # |
35
|
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$a(OCoLC)699492599 |
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Obsolete |
39
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$a332252$cTLC |
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Cat. Source |
40
|
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$aCaBNVSL$cCaBNVSL$dCaBNVSL |
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LC Call |
50
|
4 |
$aRS190.B55$bD456 2010 |
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NLM Call # |
60
|
4 |
$aTP248.13$bD456p 2010 |
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Dewey Class |
82
|
04 |
$a615.19$222 |
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ME:Pers Name |
100
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1 |
$aDelaCruz, Neslihan. |
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Title |
245
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10 |
$aProcess monitoring and quality by design for biotechnology products$h[electronic resource] /$cNeslihan DelaCruz. |
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Imprint |
260
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$aSan Rafael, Calif. (1537 Fourth Street, San Rafael, CA 94901 USA) :$bMorgan & Claypool,$cc2010. |
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Phys Descrpt |
300
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$a1 electronic text (ix, 28 p. : ill.) :$bdigital file. |
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Series:Diff |
490
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1 |
$aBiotechnology ;$v# 1 |
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Note:General |
500
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$aPart of: Colloquium digital library of life sciences. |
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Note:General |
500
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$aSeries from website. |
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Note:Bibliog |
504
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$aIncludes bibliographical references (p. 27-28). |
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Note:Content |
505
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0 |
$aAbbreviations -- 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 -- 6. Conclusion -- 7. Bibliography. |
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Abstract |
520
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3 |
$aTraditional pharmaceutical development is an unwieldy process requiring extensive experimentation and long lead times before process scientists can fully understand the effect that process parameters such as pH, temperature, cell viability, or process yield may have on the product acceptability. Implementation of quality by design is a science-based approach that allows the operating ranges and the acceptance criteria to be established based on the impact on product quality attributes. During manufacturing, process monitoring becomes part of a continuous verification effort and statistical control limits can be used to signal potential trends or drifts in the process. Single manufacturing batches that are aberrant are readily identified. The melding of scientific understanding, information systems architecture, instrumentation, software, and personnel training provides a large return on investment by ensuring that the manufacturing process produces a consistent pharmaceutical product that meets acceptable release standards for human use. |
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Note:Addl Fm |
530
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$aAlso available in print. |
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Tag 588 |
588
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$aTitle from PDF t.p. (viewed on November 11, 2010). |
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Subj:Topical |
650
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0 |
$aPharmaceutical biotechnology$xQuality control. |
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Subj:Topical |
650
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0 |
$aBiological products$xQuality control. |
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Host Item |
773
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0 |
$tBuhl Colloquium eBooks |
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SE:Ufm Title |
830
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0 |
$aColloquium digital library of life sciences. |
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SE:Ufm Title |
830
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0 |
$aColloquium series on biotechnology. |
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Elec Loc'n |
856
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40 |
$uhttp://dx.doi.org/10.4199/C00019ED1V01Y201011BTY001$yClick for access to full text electronic version of this title. |
