Managing particulates in cellular therapy

Cytotherapy

Volumn 14, Issue 9, 2012, Pages 1032-1040

  Clarke, Dominic ^a,b   Harati, Dorit ^c   Martin, Jerold ^d   Rowley, Jon ^a,e   Keller, Juergen ^f   McCaman, Michael ^e   Carrion, Miguel ^e   Karnieli, Ohad ^a,g   Maziarz, Richard ^h   Perry, Robert ⁱ   Oh, Steve ^a,j   Stanton, Jean ^k  

^a International Society for Cellular Therapy Process and Product Development Subcommittee   (United States)

^b Charter Medical Ltd   (United States)

^c Gamida Cell Ltd Cell Therapy Technologies   (Israel)

^d PALL CORPORATION   (United States)

^e Lonza Walkersville Inc   (United States)

^f MILTENYI BIOTEC GMBH   (Germany)

^g PLURISTEM THERAPEUTICS INC   (Israel)

^h OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

ⁱ ATHERSYS INC   (United States)

^j AGENCY FOR SCIENCE   (Singapore)

^k JOHNSON AND JOHNSON   (United States)

more..

Author keywords

Cellular therapy; Disposable; Injectable; Parenteral; Particulate

Indexed keywords

CELL THERAPY AGENT;

ANALYTIC METHOD; CELL THERAPY; CELL VIABILITY; CONTAMINATION; CULTURE MEDIUM; DISPOSABLE EQUIPMENT; DRUG FORMULATION; DRUG INDUSTRY; DRUG INJECTION VOLUME; DRUG MANUFACTURE; DYNAMIC LIGHT SCATTERING; FLOW CYTOMETRY; FLOW IMAGING MICROSCOPY; FOOD AND DRUG ADMINISTRATION; GEL PERMEATION CHROMATOGRAPHY; GOOD MANUFACTURING PRACTICE; HEALTH CARE ORGANIZATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LIGHT SCATTERING; MICROORGANISM; MICROSCOPY; NONHUMAN; PARTICLE SIZE; PARTICULATE MATTER; POLYACRYLAMIDE GEL ELECTROPHORESIS; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; SERUM; SUSPENSION;

EID: 84866517094     PISSN: 14653249     EISSN: 14772566     Source Type: Journal    
DOI: 10.3109/14653249.2012.706709     Document Type: Article

References (19)

1. Roback JD., C ombs MR, G rossman BJ, H illyer CD. A merican Association of Blood Banks (AABB) Technical Manual. 17th ed. Bethesda: AABB; 2011.2. USP. 7 89. Particle Matter in Ophthalmic Solutions. Rockville, MD: USP; 2005.
2. American Pharmaceutical Association. NF VI. Washington, DC: American Pharmaceutical Association; 1936.
3. Pfl ag SC. Large volume parenteral solutions procured by the military. Paper presented at: FDA National Symposium, Safety of Large Volume Parenteral Solutions; Rochville MD, July 28-29; 1968.
4. McEwen J. A History of Therapeutic Goods Regulation in Australia. Barton Australia: Attorney General's Department; 2007.
5. Aldrich S. Historical Perspective and Current Chapters Review. USP Workshop on PArticle Size: Particle Detection and Measurement. Rockville, MD, December 8-10, 2010.
6. USP. USP 788 General Chapter. Particulate Matter in Injections. Rockville, MD: USP; 2007.
7. USP. USP 31 General Chapter 1. Rockville, MD: USP; 2008.
8. Singh SK, A fonina N, A wwad M, B echtold-Peters K, B lue JT, Chou D, et al. An industry perspective on the monitoring of sub visible particles as a quality attribute for protein therapeutics. J Pharm Sci. 2010; 99 : 3302 - 21.
9. Sharma DK, K ing D, O ma P, M erchant C. M icro-fl ow imaging: Fl ow microscopy applied to sub-visible particulate analysis in protein formulations. J Am Assc Pharm Soc. 2010; 12 : 455 - 64.
10. Bryan A K, E ngler A, G ulati A, M analis SR. C ontinuous and long-term volume measurements with a commercial coulter counter. PLoS One. 2012; 7 : e29866.
11. Nam K H, Y eom E, H a H, L ee S J. S imultaneous measurement of red blood cell aggregation and whole blood coagulation using high-frequency ultrasound. Ultra Med Biol. 2012;38:468-75.
12. Angelillo-Scherrer A. L eukocyte-derived microparticles in vascular homeostasis. Circ Res. 2012; 110 : 356 - 69.
13. Huang L, X ie L, B oyd JM, L i XF. C ell-electronic sensing of particle-induced cellular responses. Analyst. 2008; 133 : 643 - 8
14. Douglas F G. F oreign particle embolism in drug addicts: Respiratory pathophysiology. Ann Intern Med. 1971; 75 : 865 - 872.
15. Richman S, Harris R D. A cute pulmonary edema associated with Librium abuse. Radiology. 1972; 103 : 57 - 58.
16. Thomas W H, Lee Y K. P articles in intravenous solutions. N Z Med J. 1974; 80 : 170 - 178.
17. Federal Drug Administration. 21 CFR 1271. Human Cells, Tissues, and Cellular and Tissue-Based Products. Rockville, MD: Bernan Publications; 2005.
18. Sundin M, R emberger M, L onnies H, S undberg B, Ringden O, Le Blanc K. No increased trapping of multipotent mesenchymal stromal cells in bone marrow fi lters compared with other bone marrow cells. Cytotherapy. 2008; 10 : 238 - 42.
19. Vicente D, Podesta M, Pitto A, Lucchetti S, Lamparelli T, Tedone E, et al. Progenitor cells trapped in bone marrow fi lters can reduce GvHD and transplant mortality. Bone Marrow Trans. 2006;38:111-17.