دورية أكاديمية
أعرض في EDS

Assessment of susceptible chemical modification sites of trastuzumab and endogenous human immunoglobulins at physiological conditions.

التفاصيل البيبلوغرافية
العنوان: Assessment of susceptible chemical modification sites of trastuzumab and endogenous human immunoglobulins at physiological conditions.
المؤلفون: Schmid I; Pharma Technical Development, Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, 82377, Germany., Bonnington L; Pharma Technical Development, Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, 82377, Germany., Gerl M; Pharma Technical Development, Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, 82377, Germany., Bomans K; Pharma Technical Development, Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, 82377, Germany., Thaller AL; Pharma Technical Development, Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, 82377, Germany., Wagner K; Pharma Technical Development, Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, 82377, Germany., Schlothauer T; Pharma Research and Early Development, Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, 82377, Germany., Falkenstein R; Pharma Technical Development, Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, 82377, Germany., Zimmermann B; Pharma Technical Development, Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, 82377, Germany., Kopitz J; Department of Applied Tumor Biology, Institute of Pathology, Medical School of the Ruprecht-Karls-University, Im Neuenheimer Feld 224, Heidelberg, 69120, Germany., Hasmann M; Pharma Research and Early Development, Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, 82377, Germany., Bauss F; Pharma Research and Early Development, Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, 82377, Germany., Haberger M; Pharma Technical Development, Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, 82377, Germany., Reusch D; Pharma Technical Development, Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, 82377, Germany., Bulau P; Pharma Technical Development, Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, 82377, Germany. patrick.bulau@roche.com.
المصدر: Communications biology [Commun Biol] 2018 Apr 05; Vol. 1, pp. 28. Date of Electronic Publication: 2018 Apr 05 (Print Publication: 2018).
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Nature Publishing Group UK Country of Publication: England NLM ID: 101719179 Publication Model: eCollection Cited Medium: Internet ISSN: 2399-3642 (Electronic) Linking ISSN: 23993642 NLM ISO Abbreviation: Commun Biol Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: London, United Kingdom : Nature Publishing Group UK, [2018]-
مستخلص: The quality control testing of chemical degradations in the bio-pharmaceutical industry is currently under controversial debate. Here we have systematically applied in vitro and in vivo stress conditions to investigate the influence of protein degradation on structure-function. Extensive purification and characterization enabled identification and functional assessment of the physiological degradation of chemical modification sites in the variable complementarity-determining regions (CDRs) and conserved region of trastuzumab. We demonstrate that the degradation of the solvent-accessible residues located in the CDR and the conserved fragment crystallizable region (Fc) occurs faster in vivo (within days) compared to the levels observed for bio-process and real-time storage conditions. These results hence question the rationality of extreme monitoring of low level alterations in such chemical modifications as critical patient safety parameters in product quality control testing, given that these modifications merely mirror the natural/physiological aging process of endogenous antibodies.
Competing Interests: The authors declare no competing interests.
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تواريخ الأحداث: Date Created: 20181002 Latest Revision: 20200111
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC6123738
DOI: 10.1038/s42003-018-0032-8
PMID: 30271914
قاعدة البيانات: MEDLINE
الوصف
تدمد:2399-3642
DOI:10.1038/s42003-018-0032-8