Quality control and analytical techniques for biopharmaceuticals

Bioanalysis

Volumn 3, Issue 1, 2011, Pages 81-95

  Robinson, C Jane ^a   Jones, Christopher ^a  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

GLYCAN; GLYCOPROTEIN; RECOMBINANT PROTEIN;

ACCURACY; ANALYTIC METHOD; BATCH PROCESS; BIOASSAY; DRUG DETERMINATION; DRUG IDENTIFICATION; DRUG POTENCY; DRUG RESEARCH; DRUG SCREENING; DRUG STABILITY; DRUG STORAGE; DRUG STRUCTURE; HUMAN; IMMUNOASSAY; INSTRUMENT VALIDATION; PHYSICAL CHEMISTRY; PROTEIN CLEAVAGE; PROTEIN DEGRADATION; PROTEIN GLYCOSYLATION; PROTEIN PROCESSING; PROTEIN SECONDARY STRUCTURE; QUALITY CONTROL; REVIEW; SHELF LIFE; STRUCTURE ANALYSIS;

BIOLOGICAL ASSAY; BIOLOGICAL FACTORS; BIOTECHNOLOGY; CHEMISTRY TECHNIQUES, ANALYTICAL; DRUG CONTAMINATION; HUMANS; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; RECOMBINANT PROTEINS; RESEARCH DESIGN; TECHNOLOGY, PHARMACEUTICAL;

EID: 79951880858     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.10.161     Document Type: Review

References (34)

1. United States Pharmacopiea USP34/NF29: biotechnology-derived articles - peptide mapping. United States Pharmacopeial Convention, Rockville, MD, USA, 537-542 (2011).
2. Rodger A, Nordén B. In: Circular Dichroism and Linear Dichroism. Oxford University Press, Oxford, UK (1997).
3. van der Weert M, Hering JA, Haris PI. Fourier transform infrared spectroscopy. In: Methods for Structural Analysis of Protein Pharmaceuticals. Jiskoot W, Crommelin JA (Eds). AAPS Press, GA, USA (2005).
4. Varley PG. Fluorescence spectroscopy. In: Methods in Molecular Biology (Edition 22). Jones C, Mulloy B, Thomas AH (Eds). Humana Press, Totowa, NJ, USA (1992).
5. Erythropoietin concentrated solution. In: European Pharmacopoeia, 6th Edition. Directorate for the Quality of Medicines and HealthCare of the Council of Europe, Strasbourg, France, 1813-1817 (2010).
6. Thobhani S, Yuen C-T, Bailey MJA, Jones C. Identification and quantification of oligosaccharides released from glycoproteins: an inter-laboratory study. Glycobiology. 19, 201-211 (2009).
7. Wada Y, Azadi P, Costello CE et al. Comparison of the methods for profiling glycoprotein glycans - Human Disease Glycomics/Proteome (HUPO) initiative multi-institutional study. Glycobiology 17(4), 411-422 (2007). (Pubitemid 46432012)
8. Wohlgemuth J, Karas M, Eichhorn T, Hendriks R, Andrecht S. Quantitative site-specific analysis of protein glycosylation by LC-MS using different glycopeptide-enrichment strategies. Anal. Biochem. 395(2), 178-188 (2009).
9. Datola A, Richert S, Bierau H et al. Characterisation of a novel growth hormone variant comprising a thioether link between Cys182 and Cys189. Chem. Med. Chem. 2(8), 1181-1189 (2007).
10. Wang X, Hunter AK, Mozier NM. Host cell proteins in biologics development: identification, quantitation and risk assessment. Biotechnol. Bioeng. 103(3), 446-458 (2009).
11. Zhu-Shimoni J, Gunawan F, Thomas A, Vanderlaan M, Stults JJ. Trace level analysis of leached protein A in bioprocess samples without interference from the large excess of rhMAb IgG. Immunol. Methods 341(1-2), 59-67 (2009).
12. Meager A, Gaines Das R, Zoon K, Mire-Sluis A. Establishment of new and replacement World Health Organization International Biological Standards for human interferon a and W. J. Immunol. Methods 257(1-2), 17-33 (2001). (Pubitemid 33001230)
13. Stebbings RJ, Findlay L, Edwards C et al. Cytokine storm in the Phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics. J. Immunol. 179(5), 3325-3331 (2007).
14. Liefooghe EC, Tiplady R, Gerson P, Lloyd P, Heath A, Bristow AF. A sialylation-sensitive cell-based in vitro bioassay for erythropoietin; incorporation of the galactose-binding Erythrina crista-galli lectin. Biologicals 33(3), 161-167 (2005). (Pubitemid 41208095)
15. Assay of human antithrombin III. In: European Pharmacopoeia, 6th Edition. Directorate for the Quality of Medicines and HealthCare of the Council of Europe, Strasbourg, France, 234 (2010).
16. Bertolotto A, Sala A, Caldano M et al. Development and validation of a real time PCR-based bioassay for quantification of neutralizing antibodies against human interferon-b. J. Immunol. Methods 321(1-2), 19-31 (2007). (Pubitemid 46441209)
17. Burns CJ, Silva MM, Gray E, Robinson CJ. Quantitative RT-PCR as an alternative to late-stage bioassays for vascular endothelial growth factor. J. Pharm. Biomed. Anal. 47, 460-468 (2008).
18. Lightbown JW. Biological standardization and the analyst: a review. J. Soc. Anal. Chem. 86, 216-230 (1961).
19. The Design and Analysis of Potency Assays. Brown, F, Mire-Sluis A (Eds). Karger, Basel, Switzerland (2002).
20. Chowdhury F, Williams A, Johnson P. Validation and comparison of two multiplex technologies, Luminex and Mesoscale Discovery, for human cytokine profiling. J. Immunol. Methods 340(1), 55-64 (2009).
21. de Moura WC, Gallina NM, Fuches RM, Romijn PC, Leite JP. Validation of a virus neutralization potency test in BHK-21 cells for rabies immunoglobulins in a two center study. J. Virol. Methods 154, 7-13 (2008).
22. Gazzano-Santoro H, Chen A, Casto B et al. Validation of a rat pheochromocytoma (PC12)-based cell survival assay for determining biological potency of recombinant human nerve growth factor. J. Pharm. Biomed. Anal. 21(5), 945-959 (1999).
23. Interferon b-1 a concentrated solution. In: European Pharmacopoeia, 6th Edition. Directorate for the Quality of Medicines and HealthCare of the Council of Europe, Strasbourg, France, 4904-4907 (2010).
24. International Conference on Harmonization Guidelines: ICH Q7. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (2000). www.ich.org/LOB/media/MEDIA433.pdf
25. International Conference on Harmonization Guidelines: ICH Q6B. Specifications: Test procedures and acceptance criteria for biotechnological/ biological products (1999). www.ich.org/LOB/media/MEDIA432.pdf
26. Hoffman K. Strategies for host cell protein analysis. www.cygnustechnologies.com/images/file/ Strategies-for-HCP.pdf.
27. International Conference on Harmonization Guidelines: ICH Q2(R1). Validation of analytical procedures: text and methodology (2005). www.ich.org/LOB/media/MEDIA417.pdf
28. OMCL Network of the Council of Europe Quality Assurance Document PA/PH/ OMCL (08) 73 R Qualification of Equipment: core document. www.edqm.eu/medias/ fichiers/NEW- Qualification-of-Equipment-core- document.pdf
29. Guideline on similar medicinal products containing biotechnology-derived proteins as active substance: quality issues: EMEA/ CHMP/BWP/49348/2005. www.emea.europa.eu/pdfs/human/ biosimilar/4934805en.pdf
30. Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, February 28, 1997. FDA CBER Center for Biologics Evaluation and Research. 28 February, 1997. www.fda.gov/downloads/ BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/ OtherRecommendationsforManufacturers/ UCM153182.pdf
31. Tesseur I, Zou K, Berber E, Zhang H, Wyss-Coray T. Highly sensitive and specific bioassay for measuring bioactive TGF-b. www.biomedcentral.com/1471- 2121/7/15
32. Robinson CJ, Little LE, Wallny HJ. Cell-based bioassays in the biopharmaceutical industry - bioassay survey 2006-2007. www.bioprocessintl.com/ journal/2008/ March/Bioassay-Survey-20062007-182361
33. International Conference on Harmonization Guidelines: ICH Q5E. Comparability of biotechnological/biological products subject to changes in their manufacturing process (2004). www.ich.org/LOB/media/MEDIA1196.pdf
34. Specifications and Control Tests on the Finished Product. Directive 75/318/EEC as amended. www.ema.europa.eu/docs/en-GB/ document-library/ Scientific- guideline/2009/09/WC500003368.pdf