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Results: 1 to 20 of 104

1.

Effects of surfaces and leachables on the stability of biopharmaceuticals.

Bee JS, Randolph TW, Carpenter JF, Bishop SM, Dimitrova MN.

J Pharm Sci. 2011 Oct;100(10):4158-70. doi: 10.1002/jps.22597. Epub 2011 Apr 26.

PMID:
21523787
[PubMed - in process]
2.

Protein aggregation and particle formation in prefilled glass syringes.

Gerhardt A, Mcgraw NR, Schwartz DK, Bee JS, Carpenter JF, Randolph TW.

J Pharm Sci. 2014 Jun;103(6):1601-12. doi: 10.1002/jps.23973. Epub 2014 Apr 11.

PMID:
24729310
[PubMed - in process]
3.

Characterization of subvisible particle formation during the filling pump operation of a monoclonal antibody solution.

Nayak A, Colandene J, Bradford V, Perkins M.

J Pharm Sci. 2011 Oct;100(10):4198-204. doi: 10.1002/jps.22676. Epub 2011 Jun 22.

PMID:
21698601
[PubMed - in process]
4.

Free Fatty Acid Particles in Protein Formulations, Part 2: Contribution of Polysorbate Raw Material.

Siska CC, Pierini CJ, Lau HR, Latypov RF, Fesinmeyer RM, Litowski JR.

J Pharm Sci. 2014 Sep 5. doi: 10.1002/jps.24144. [Epub ahead of print]

PMID:
25196966
[PubMed - as supplied by publisher]
5.

Calculating the Mass of Subvisible Protein Particles with Improved Accuracy Using Microflow Imaging Data.

Kalonia C, Kumru OS, Prajapati I, Mathaes R, Engert J, Zhou S, Middaugh CR, Volkin DB.

J Pharm Sci. 2014 Oct 9. doi: 10.1002/jps.24156. [Epub ahead of print]

PMID:
25302696
[PubMed - as supplied by publisher]
6.

Biologics formulation factors affecting metal leachables from stainless steel.

Zhou S, Schöneich C, Singh SK.

AAPS PharmSciTech. 2011 Mar;12(1):411-21. doi: 10.1208/s12249-011-9592-3. Epub 2011 Mar 1.

PMID:
21360314
[PubMed - indexed for MEDLINE]
Free PMC Article
7.

On developing a process for conducting extractable-leachable assessment of components used for storage of biopharmaceuticals.

Wakankar AA, Wang YJ, Canova-Davis E, Ma S, Schmalzing D, Grieco J, Milby T, Reynolds T, Mazzarella K, Hoff E, Gomez S, Martin-Moe S.

J Pharm Sci. 2010 May;99(5):2209-18. doi: 10.1002/jps.22012. Review.

PMID:
20039383
[PubMed - indexed for MEDLINE]
8.

Control of protein particle formation during ultrafiltration/diafiltration through interfacial protection.

Callahan DJ, Stanley B, Li Y.

J Pharm Sci. 2014 Mar;103(3):862-9. doi: 10.1002/jps.23861. Epub 2014 Jan 21.

PMID:
24449131
[PubMed - indexed for MEDLINE]
Free Article
9.

Formulation and Stability of Cytokine Therapeutics.

Lipiäinen T, Peltoniemi M, Sarkhel S, Yrjönen T, Vuorela H, Urtti A, Juppo A.

J Pharm Sci. 2014 Dec 9. doi: 10.1002/jps.24243. [Epub ahead of print]

PMID:
25492409
[PubMed - as supplied by publisher]
10.

Impact of extractables/leachables from filters on stability of protein formulations.

Huang M, Horwitz TS, Zweiben C, Singh SK.

J Pharm Sci. 2011 Nov;100(11):4617-30. doi: 10.1002/jps.22670. Epub 2011 Jun 21.

PMID:
21695696
[PubMed - indexed for MEDLINE]
11.

Competitive Adsorption of Monoclonal Antibodies and Nonionic Surfactants at Solid Hydrophobic Surfaces.

Kapp SJ, Larsson I, DE Weert MV, Cárdenas M, Jorgensen L.

J Pharm Sci. 2014 Dec 1. doi: 10.1002/jps.24265. [Epub ahead of print]

PMID:
25446557
[PubMed - as supplied by publisher]
12.

The influence of size, structure and hydrophilicity of model surfactants on the adsorption of lysozyme to oil-water interface--interfacial shear measurements.

Baldursdottir SG, Jorgensen L.

Colloids Surf B Biointerfaces. 2011 Oct 1;87(1):96-102. doi: 10.1016/j.colsurfb.2011.05.007. Epub 2011 May 10.

PMID:
21628092
[PubMed - indexed for MEDLINE]
13.

The effects of excipients on protein aggregation during agitation: an interfacial shear rheology study.

Liu L, Qi W, Schwartz DK, Randolph TW, Carpenter JF.

J Pharm Sci. 2013 Aug;102(8):2460-70. doi: 10.1002/jps.23622. Epub 2013 May 27.

PMID:
23712900
[PubMed - indexed for MEDLINE]
Free PMC Article
14.
15.

Leachables evaluation for bulk drug substance.

Tsui V, Somma MS, Zitzner LA.

PDA J Pharm Sci Technol. 2009 Mar-Apr;63(2):168-83.

PMID:
19634355
[PubMed - indexed for MEDLINE]
16.

A compilation of safety impact information for extractables associated with materials used in pharmaceutical packaging, delivery, administration, and manufacturing systems.

Jenke D, Carlson T.

PDA J Pharm Sci Technol. 2014 Sep-Oct;68(5):407-55. doi: 10.5731/pdajpst.2014.00995.

PMID:
25336416
[PubMed - in process]
17.

Effects of Syringe Material and Silicone Oil Lubrication on the Stability of Pharmaceutical Proteins.

Krayukhina E, Tsumoto K, Uchiyama S, Fukui K.

J Pharm Sci. 2014 Sep 24. doi: 10.1002/jps.24184. [Epub ahead of print]

PMID:
25256796
[PubMed - as supplied by publisher]
18.

Surfactant solutions and porous substrates: spreading and imbibition.

Starov VM.

Adv Colloid Interface Sci. 2004 Nov 29;111(1-2):3-27.

PMID:
15571660
[PubMed - indexed for MEDLINE]
19.

IgG1 aggregation and particle formation induced by silicone-water interfaces on siliconized borosilicate glass beads: a model for siliconized primary containers.

Basu P, Krishnan S, Thirumangalathu R, Randolph TW, Carpenter JF.

J Pharm Sci. 2013 Mar;102(3):852-65. doi: 10.1002/jps.23434. Epub 2012 Dec 29.

PMID:
23280943
[PubMed - indexed for MEDLINE]
20.

Recombinant factor VIII SQ--the influence of formulation parameters on structure and surface adsorption.

Fatouros A, Sjöström B.

Int J Pharm. 2000 Jan 20;194(1):69-79.

PMID:
10601686
[PubMed - indexed for MEDLINE]
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