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1

Low-Volume Aseptic Filling Using a Linear Peristaltic Pump.

Dreckmann T, Ludwig IS, Luemkemann J, Huwyler J. Dreckmann T, et al. PDA J Pharm Sci Technol. 2021 May-Jun;75(3):245-257. doi: 10.5731/pdajpst.2020.011858. Epub 2020 Oct 16. PDA J Pharm Sci Technol. 2021. PMID: 33067332

2

Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes.

Dreckmann T, Aipperspach W, Pfleghar K, TrÖndle J, Ernst A, Huwyler J, Ludwig IS, Luemkemann J. Dreckmann T, et al. PDA J Pharm Sci Technol. 2020 Nov-Dec;74(6):660-673. doi: 10.5731/pdajpst.2019.011270. Epub 2020 Jul 16. PDA J Pharm Sci Technol. 2020. PMID: 32675305

3

Low volume aseptic filling: Impact of pump systems on shear stress.

Dreckmann T, Boeuf J, Ludwig IS, Lümkemann J, Huwyler J. Dreckmann T, et al. Eur J Pharm Biopharm. 2020 Feb;147:10-18. doi: 10.1016/j.ejpb.2019.12.006. Epub 2019 Dec 10. Eur J Pharm Biopharm. 2020. PMID: 31837391 Free article.

4

Filling of High-Concentration Monoclonal Antibody Formulations: Investigating Underlying Mechanisms That Affect Precision of Low-Volume Fill by Peristaltic Pump.

Shieu W, Lamar D, Stauch OB, Maa YF. Shieu W, et al. PDA J Pharm Sci Technol. 2016 Mar-Apr;70(2):143-56. doi: 10.5731/pdajpst.2015.005926. Epub 2016 Jan 21. PDA J Pharm Sci Technol. 2016. PMID: 26797970

5

Mechanistic Study of Drying Phenomena of Highly Concentrated Protein Therapeutics-Drying Kinetics and Protein Aggregation.

Allmendinger A, Ni Y, Bernhard A, Nalenz H. Allmendinger A, et al. PDA J Pharm Sci Technol. 2022 Jan-Feb;76(1):52-64. doi: 10.5731/pdajpst.2020.012492. Epub 2021 Jul 19. PDA J Pharm Sci Technol. 2022. PMID: 34282036

6

Investigating and Addressing Challenges Associated with Filling Protein Drug Products.

Pardeshi N, Marsiglio D, Padmakumar V, Bernacki J, Rathore N. Pardeshi N, et al. J Pharm Sci. 2023 Apr;112(4):954-962. doi: 10.1016/j.xphs.2022.11.017. Epub 2022 Nov 25. J Pharm Sci. 2023. PMID: 36442684

7

Filling of high-concentration monoclonal antibody formulations into pre-filled syringes: filling parameter investigation and optimization.

Shieu W, Torhan SA, Chan E, Hubbard A, Gikanga B, Stauch OB, Maa YF. Shieu W, et al. PDA J Pharm Sci Technol. 2014 Mar-Apr;68(2):153-63. doi: 10.5731/pdajpst.2014.00973. PDA J Pharm Sci Technol. 2014. PMID: 24668602

8

Syringe Filling of High-Concentration mAb Products Using Peristaltic Pump-Based Mechanism: Challenges and Mitigation Strategies.

Desai KG, Colandene JD, Gidh A, Hanslip S, Rastelli M. Desai KG, et al. J Pharm Sci. 2022 Mar;111(3):562-576. doi: 10.1016/j.xphs.2021.09.016. Epub 2021 Sep 20. J Pharm Sci. 2022. PMID: 34551352

9

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

10

Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product-Hydrogen Peroxide Uptake and Impact on Protein Quality.

Hubbard A, Roedl T, Hui A, Knueppel S, Eppler K, Lehnert S, Maa YF. Hubbard A, et al. PDA J Pharm Sci Technol. 2018 Jul-Aug;72(4):348-366. doi: 10.5731/pdajpst.2017.008326. Epub 2018 Mar 15. PDA J Pharm Sci Technol. 2018. PMID: 29545321

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