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Record W2245303227

Будущее технологий биофармацевтического производства

2011· article· ru· W2245303227 on OpenAlexaboutno aff
E. S. Kharyunina

Bibliographic record

VenueБиофармацевтический журнал · 2011
Typearticle
Languageru
FieldImmunology and Microbiology
TopicBiosimilars and Bioanalytical Methods
Canadian institutionsnot available
Fundersnot available
KeywordsMedicine
DOInot available

Abstract

fetched live from OpenAlex

Поскольку в биофармацевтической отрасли постоянный масштабный рост производства выходит из моды, необходимо наряду с модернизацией уже устаревших подходов применять и инновационные. В статье сделан обзор состояния технологической базы для проведения «даун-стрим» процесса и рассмотрены потенциально возможные решения. Список ссылок Gottschalk U. / Biopharm. Intl Suppl.. 2006. V. 19. P. 8–9. Hacker D.L., Jesus M. De, and Wurm F.M. / Biotechnol. Adv. 2009. V. 27. P. 1023–1027. Rathore A.S. and Winkle H. / Nat. Biotechnol. 2009. V. 27. P. 26–34. Berthold W., Proceeds. of BioManufacturing World. --- Shanghai, China, 2010. Wurm F.M. / Nature. 2004. V. 22. P. 1393–1398. Aldridge S. / GEN. 2006. V. 26. № 1. Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach. / FDA. --- Rockville, MD, August 2002. PAT Guidance for Industry: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance / FDA. --- Rockville, MD, September 2004. Thiel K.A. / Nat. Biotechnol. 2004. V. 22. P. 1365–1372. Sheridan C. / Nat. Biotechnol. 2010. V. 28. P. 307–310. Walsh G. / Nat. Biotechnol. 2010. V. 28. P. 917–924. Gottschalk U. / BioPharm. Intl. Suppl. 2005. V. 18. № 3. P. 24–28. S. Vedantham V. G. and Hubbard B. / Process Scale. Purification of Antibodies, U. Gottschalk (ed.). --- NY: Wiley, 2009. P. 79–102. Glynn J. et al / Biopharm. Intl. Suppl. 2009. V.22. P.15-19. Glynn J. et al., Development of a MAb harvest protocol. Biochemical Engineering XV: Engineering Biology from Biomolecules to Complex Systems. --- Quebec City, Canada, July 15-19 2007. Thommes J. and Etzel M. / Biotechnol. Prog. 2007. V. 23. P. 42-45. Thommes J. and Gottschalk U / Process Scale Purification of Antibodies, U. Gottschalk (ed.). --- NY: Wiley, 2009. P. 293–308. Shulka A.A. and Kandula J.R / Ibid. P. 53–78. Shpritzer R. et al., 232nd ACS National Meeting. --- San Francisco CA, 2006. Glynn J / Process Scale Purification of Antibodies, U. Gottschalk (ed.). --- NY: Wiley, 2009. P. 309–324. Przybycien T., Narahari S., and Steele L. / Biotechnol. 2004. V. 15. P. 469–478. Kent U. / Meth. Mol. Biol. 1999. V. 115. P. 11–18. Page M. and Thorpe R / The Protein Protocols Handbook, 2nd ed., J.M. Walker (ed.). --- Totowa, NJ: Humana Press, 2002. P. 983–984. Lebing W. et al. / Vox Sanguinis. 2003. V. 84. P. 193–201. Parkkinen J. et al. / Vox Sanguinis. 2006. V. 90. P. 97–104. Klyushnichenko V. / Curr. Opin. Drug. Disc. Dev. 2003. V. 6. P. 848–854. Yang et al. M.X. / Proc. Natl. Acad. Sci. USA. 2003. V. 100. P. 6934–6939. Peters J., Minuth T., and Schroder W. / Protein Expr. Purif. 2005. V. 39. P. 43–53. Curling J. and Gottschalk U. / BioPharm. Intl. 2007. V. 21. P. 70–94 Gottschalk U. / Adv. Biochem. Eng. Biotechnol. 2010. V. 115. P. 171-183 Walter J.K. et al. / Protein Purification: Principles, High Resolution Methods, and Applications, 3rd ed., J.C. Janson (ed.). --- NY: Wiley, 2011. Gottschalk U. / Biotechnol. Prog. 2008. V. 24. P. 496-503. Zhou J. and Tressel T. / Biotechnol. Prog. 2006. V. 22. P. 341–349. Thommes J. and Kula M.R. / Biotechnol. Prog. 1995. V. 11. P. 357–367. Fraud N. et al., BioPharm. Intl. 2009. V. 23. P. 24–27. Faber R., Yang Y., and Gottschalk U., BioPharm. Intl. 2009. V. 23. P. 11–14. Giovannoni L., Ventani M., and Gottschalk U., BioPharm. Intl. 2009. V. 23. № 3. Curtis S. et al. / Biotechnol. Bioeng. 2003. V. 84. P. 179–186. Norling L. / J. Chromatogr. 2005. V. 1069. P. 79–89.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.001
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow), Science and technology studies, Research integrity, Insufficient payload (model declined to judge)
Consensus categoriesMeta-epidemiology (narrow), Research integrity, Insufficient payload (model declined to judge)
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.787
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0020.001
Meta-epidemiology (narrow)0.0020.002
Meta-epidemiology (broad)0.0030.002
Bibliometrics0.0010.002
Science and technology studies0.0010.003
Scholarly communication0.0000.001
Open science0.0030.001
Research integrity0.0040.003
Insufficient payload (model declined to judge)0.0610.014

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.084
GPT teacher head0.287
Teacher spread0.203 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; both teacher heads agree on what is shown here.

Study designNot applicable
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

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Citations0
Published2011
Admission routes1
Has abstractyes

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