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1

Mechanistic Investigation on Grinding-Induced Subvisible Particle Formation during Mixing and Filling of Monoclonal Antibody Formulations.

Gikanga B, Hui A, Maa YF. Gikanga B, et al. PDA J Pharm Sci Technol. 2018 Mar-Apr;72(2):117-133. doi: 10.5731/pdajpst.2017.007732. Epub 2017 Oct 12. PDA J Pharm Sci Technol. 2018. PMID: 29030532

2

Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress.

Gikanga B, Eisner DR, Ovadia R, Day ES, Stauch OB, Maa YF. Gikanga B, et al. PDA J Pharm Sci Technol. 2017 May-Jun;71(3):172-188. doi: 10.5731/pdajpst.2016.006726. Epub 2016 Oct 27. PDA J Pharm Sci Technol. 2017. PMID: 27789805

3

Mixing monoclonal antibody formulations using bottom-mounted mixers: impact of mechanism and design on drug product quality.

Gikanga B, Chen Y, Stauch OB, Maa YF. Gikanga B, et al. PDA J Pharm Sci Technol. 2015 Mar-Apr;69(2):284-96. doi: 10.5731/pdajpst.2015.01031. PDA J Pharm Sci Technol. 2015. PMID: 25868994

4

A Review on Mixing-Induced Protein Particle Formation: The Puzzle of Bottom-Mounted Mixers.

Gikanga B, Maa YF. Gikanga B, et al. J Pharm Sci. 2020 Aug;109(8):2363-2374. doi: 10.1016/j.xphs.2020.03.024. Epub 2020 Mar 30. J Pharm Sci. 2020. PMID: 32240688 Review.

5

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

Nayak A, Colandene J, Bradford V, Perkins M. Nayak A, et al. J Pharm Sci. 2011 Oct;100(10):4198-204. doi: 10.1002/jps.22676. Epub 2011 Jun 22. J Pharm Sci. 2011. PMID: 21698601

6

Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying-the Road to Manufacturing Scale.

Gikanga B, Turok R, Hui A, Bowen M, Stauch OB, Maa YF. Gikanga B, et al. PDA J Pharm Sci Technol. 2015 Jan-Feb;69(1):59-73. doi: 10.5731/pdajpst.2015.01003. PDA J Pharm Sci Technol. 2015. PMID: 25691715

7

Characterization of Grinding-Induced Subvisible Particles and Free Radicals in a Freeze-Dried Monoclonal Antibody Formulation.

Jing ZY, Huo GL, Sun MF, Shen BB, Fang WJ. Jing ZY, et al. Pharm Res. 2022 Feb;39(2):399-410. doi: 10.1007/s11095-022-03170-9. Epub 2022 Jan 26. Pharm Res. 2022. PMID: 35083639

8

Characterization of Inherent Particles and Mechanism of Thermal Stress Induced Particle Formation in HSV-2 Viral Vaccine Candidate.

Li L, Kirkitadze M, Bhandal K, Roque C, Yang E, Carpick B, Rahman N. Li L, et al. Curr Pharm Biotechnol. 2017 Nov 10;18(8):638-647. doi: 10.2174/1389201018666170914123305. Curr Pharm Biotechnol. 2017. PMID: 28914197

9

Evaluation of the effect of syringe surfaces on protein formulations.

Majumdar S, Ford BM, Mar KD, Sullivan VJ, Ulrich RG, D'souza AJ. Majumdar S, et al. J Pharm Sci. 2011 Jul;100(7):2563-73. doi: 10.1002/jps.22515. Epub 2011 Feb 11. J Pharm Sci. 2011. PMID: 21319164

10

Evaluating the Role of the Air-Solution Interface on the Mechanism of Subvisible Particle Formation Caused by Mechanical Agitation for an IgG1 mAb.

Ghazvini S, Kalonia C, Volkin DB, Dhar P. Ghazvini S, et al. J Pharm Sci. 2016 May;105(5):1643-1656. doi: 10.1016/j.xphs.2016.02.027. Epub 2016 Mar 26. J Pharm Sci. 2016. PMID: 27025981

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