Development of a pilot-scale manufacturing process for protein-coated microcrystals (PCMC): Mixing and precipitation - Part i

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 80, Issue 3, 2012, Pages 490-498

  König, Corinna ^a   Bechtold Peters, Karoline ^a   Baum, Verena ^a   Schultz Fademrecht, Torsten ^a   Bassarab, Stefan ^a   Steffens, Klaus Jürgen ^b  

^a BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^b UNIVERSITY OF BONN   (Germany)

Author keywords

Impingement jet mixer; Microcrystals; PCMC; Precipitation; Protein; Stabilisation

Indexed keywords

GLYCINE; MONOCLONAL ANTIBODY; PROTEIN; SOLVENT;

AQUEOUS SOLUTION; ARTICLE; CHEMICAL REACTION; COMPUTATIONAL FLUID DYNAMICS; CRYSTAL; CRYSTALLIZATION; DEVICES; DOUBLE JET IMPINGEMENT MIXER; ENERGY; FLOW RATE; LAMINAR FLOW; PARTICLE SIZE; PRECIPITATION; PROCESS DEVELOPMENT; PROTEIN COATED MICROCRYSTAL; PROTEIN STABILITY; QUADRUPLE JET IMPINGEMENT MIXER; REDUCTION; SCANNING ELECTRON MICROSCOPY; SOLVENT EFFECT; STORAGE TEMPERATURE; SUSPENSION; TURBIDITY; VILLERMAUX DUSHMAN REACTION; X RAY DIFFRACTION;

BIOLOGICAL AGENTS; CHEMICAL PRECIPITATION; CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; DEHYDRATION; DRUG CARRIERS; PARTICLE SIZE; PROTEINS; SOLVENTS; WATER;

EID: 84858154626     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2011.11.012     Document Type: Article

References (22)

1. M.C. Manning, K. Patel, and R.T. Borchardt Stability of protein pharmaceuticals Pharmaceutical Research 6 11 1989 903 918 (Pubitemid 20078439)
2. K. Schumacher, G. Winter, and M.H.C. Mahler Instabilitaeten Von Proteinarzneimitteln PZ Prisma 10 1 2003 15 18
3. W. Wang, S. Singh, D.L. Zeng, K. King, and S. Nema Antibody structure, instability, and formulation Journal of Pharmaceutical Sciences 96 1 2007 1 26 (Pubitemid 46087335)
4. J.F. Carpenter, B.S. Chang, W. Garzon-Rodriguez, and T.W. Randolph Rational design of stable lyophilized protein formulations: theory and practice Pharmaceutical Biotechnology 13 2002 109 133
5. M.C. Lai, and E.M. Topp Solid-state chemical stability of proteins and peptides Journal of Pharmaceutical Sciences 88 5 1999 489 500 (Pubitemid 29220973)
6. S. Schuele Stabilization of Antibodies in spray dried Powders for Inhalation 2005 LMU University Munich Dissertation
7. V. Kumar, V.K. Sharma, and D.S. Kalonia In situ precipitation and vacuum drying of interferon alpha-2a: development of a single-step process for obtaining dry, stable protein formulation International Journal of Pharmaceutics 366 1-2 2009 88 98
8. H. Gieseler, Product Morphology and Drying Behavior Delineated by a New Freeze-drying Microbalance. Naturwissenschaftliche Fakultaet der Friedrich-Alexander-Universitaet Erlangen-Nuernberg, 2004.
9. Maa YF, Nguyen PA, inventors; Genentech I, assignee. Method of spray freeze drying proteins for pharmaceutical administration. US patent 6284282. 1999 Apr 27.
10. N. Jovanovic, A. Bouchard, G.W. Hofland, G.J. Witkamp, D.J.A. Crommelin, and W. Jiskoot Stabilization of proteins in dry powder formulations using supercritical fluid technology Pharmaceutical Research 21 11 2004 1955 1969 (Pubitemid 40941214)
11. E. Reverchon Supercritical antisolvent precipitation of micro-and nano-particles The Journal of Supercritical Fluids 15 1 1999 1 21 (Pubitemid 129671809)
12. S.P. Cape, J.A. Villa, E.T.S. Huang, T.H. Yang, J.F. Carpenter, and R.E. Sievers Preparation of active proteins, vaccines and pharmaceuticals as fine powders using supercritical or near-critical fluids Pharmaceutical Research 25 9 2008 1967 1990
13. B. Shenoy, Y. Wang, W. Shan, and A.L. Margolin Stability of crystalline proteins Biotechnology and Bioengineering 73 5 2001 358 369 (Pubitemid 32493232)
14. K.A. Johnson Preparation of peptide and protein powders for inhalation Advanced Drug Delivery Reviews 26 1 1997 3 15 (Pubitemid 27288480)
15. B.D. Moore, M. Parker, P.J. Halling, J. Partridge, H.N.E. Stevens, Inventors; WO 00/69887 Rapid Dehydration of Proteins, 2000.
16. J. Partridge, P.R. Dennison, B.D. Moore, and P.J. Halling Activity and mobility of subtilisin in low water organic media: hydration is more important than solvent dielectric Biochimica et Biophysica Acta (BBA)/Protein Structure and Molecular Enzymology 1386 1 1998 79 89 (Pubitemid 29333219)
17. S. Murdan, S. Somavarapu, A.C. Ross, H.O. Alpar, and M.C. Parker Immobilisation of vaccines onto micro-crystals for enhanced thermal stability International Journal of Pharmaceutics 296 1-2 2005 117 121 (Pubitemid 40693380)
18. A. Ganesan, N.C. Price, S.M. Kelly, I. Petry, B.D. Moore, and P.J. Halling Circular dichroism studies of subtilisin Carlsberg immobilised on micron sized silica particles BBA-Proteins and Proteomics 1764 6 2006 1119 1125 (Pubitemid 44192418)
19. M. Kreiner, J.F.A. Fernandes, N. O'Farrell, P.J. Halling, and M.C. Parker Stability of protein-coated microcrystals in organic solvents Journal of Molecular Catalysis B: Enzymatic 33 3-6 2005 65 72 (Pubitemid 40719662)
20. B.K. Johnson, and R.K. Prud'Homme Chemical processing and micromixing in confined impinging jets AIChE Journal 49 9 2003 2264 2282 (Pubitemid 37163187)
21. J.L. Luche Synthetic Organic Sonochemistry 1998 Plenum Press New York
22. I.L.M. Verschuren, Feed Stream Mixing in Stirred Tank Reactors, Ph.D. Thesis. Technische Universiteit Eindhoven, 2001. ISBN 90-386-2942-7.