Abstract
A microparticle analysis strategy in therapeutic protein manufacturing NC investigation is outlined for the biopharmaceutical industry. The general approach for NC investigation and the principles of the primary analytical technologies and procedures are presented. This chapter will provide some insight into microparticle NC investigations, the challenges it faces, and how it fits into the overall application of biophysical and analytical methods to biopharmaceutical development and manufacturing. Case studies of NC investigations of protein therapeutics are presented, which involve products contained in both prefilled glass syringes and glass vials.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Barber TA (2000) Control of particulate matter contamination in healthcare manufacturing. Interpharm, Denver
Cao X, Wen ZQ, Vance A, Torraca G (2009) Raman microscopic applications in the biopharmaceutical industry: in situ identification of foreign particulates inside glass containers with aqueous formulated solutions. Appl Spectrosc 63:830–834
Cao X, Masatani P, Torraca G, Wen ZQ (2010) Identification of a mixed microparticle by combined microspectroscopic techniques: a real forensic case study in the biopharmaceutical industry. Appl Spectrosc 64:895–900
Goldstein JI, Newbury DE, Echlin P, Joy DC, Romig AD Jr, Lyman CE, Fiori C, Lifshin E (1992) Scanning electron microscopy and X-ray microanalysis, 2nd edn. Plenum, New York
Humecki HJ (1995) Practical guide to infrared microspectroscopy. CRC, New York
Iacocca RG, Allgeier M (2007) Corrosive attack of glass by a pharmaceutical compound. J Mater Sci 42:801–811
Jiang Y, Nashed-Samuel Y, Li C, Liu W, Pollastrini J, Mallard D, Wen ZQ, Fujimori K, Pallitto M, Donahue L, Chu G, Torraca G, Vance A, Mire-Sluis T, Freund E, Davis J, Narhi LO (2009) Tungsten-induced protein aggregation: solution behavior. J Pham Sci 98:4695–4710
Kuan H-C, Su H-Y, Ma C-C (2005) Synthesis and characterization of polysilicic acid nanoparticles/waterborne polyurethane nanocomposite. J Mater Sci 40(23):6063–6070
Li G, Torraca G, Jing W, Wen Z-Q (2009) Applications of FTIR in identification of foreign materials for biopharmaceutical clinical manufacturing. Vib Spectrosc 50:152–159
Liu W, Swift R, Torraca G, Nashed-Samuel Y, Wen ZQ, Jiang Y, Vance A, Mire-Sluis A, Freund E, Davis J, Narhi LO (2010) Root cause analysis of tungsten-induced protein aggregation in pre-filled syringes. PDA Pharm J Sci Technol 64:11–19
Nail SL, Akers MJ (2002) Development and manufacture of protein pharmaceuticals. Springer, New York
Narhi LO, Schmit J, Bechtold-Peters K, Sharma D (2012) Classification of protein aggregates. J Pharm Sci 101:493–498
Perera G, Doremus RH (1991) Dissolution rates of silica glasses in water at pH 7. J Am Ceram Soc 74(6):1269–1274
Ricci MS, Hair A, Thirumangalath R, Dharmavaram V, Piedmonte D, Latypov R, Lau H, Bjorklund J, Callahan W, Purtell J, Abel J, Li G, Fujimori K, Torraca G, Jing W, Wen Z-Q, Nashed-ÂSamuel Y, Ratnaswamy G, Swift R (2011) Glass dissolution and delamination in formulation development: implications for neutral pH product development. In: American Chemical Society Division of Biochemical Technology 241st ACS national meeting, Anaheim, 27–31 March 2011
Rosenberg AA (2006) Effects of protein aggregates: an immunologic perspective. AAPS J 8(3):E501–E507
Shermann C, Brodbelt J (2002) Knowitall analytical system. J Am Chem Soc 124:7
Smith B (1999) Infrared spectral interpretation: a systematic approach. CRC, New York
United States Pharmacopeia 29-Formulary 24 (2012), p 2722 (Chap. 788) USP 35-NF30
Wen ZQ (2007) Raman spectroscopy of protein pharmaceuticals. J Pharm Sci 96:2861–2878
Wen Z-Q, Torraca G, Yee C, Li G (2007) Investigation of contaminants in protein pharmaceuticals in pre-filled syringes by multiple microspectroscopies. Am Pharm Rev 10:101–109
Wen ZQ, Cao X, Vance A (2008) Conformation and side chains environments of recombinant human interleukin-1 receptor antagonist (rh-IL-1ra) probed by Raman, Raman optical activity, and UV-resonance Raman spectroscopy. J Pharm Sci 97:2228–2241
Wen ZQ, Vance A, Vega F, Cao X, Eu B, Schulthesis R (2009) Distribution of silicone oil in prefilled glass syringes probed with optical and spectroscopic methods. PDA Pharm J Sci Technol 63:149–158
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2013 Springer Science+Business Media New York
About this chapter
Cite this chapter
Wen, ZQ., Torraca, G., Li, G., Cao, X., Yee, C.K. (2013). Investigation of Nonconformance During Protein Therapeutic Manufacturing. In: Narhi, L. (eds) Biophysics for Therapeutic Protein Development. Biophysics for the Life Sciences, vol 4. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-4316-2_10
Download citation
DOI: https://doi.org/10.1007/978-1-4614-4316-2_10
Published:
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4614-4315-5
Online ISBN: 978-1-4614-4316-2
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)