Mckertish CM, Kayser V. Advances and limitations of antibody drug conjugates for cancer. Biomedicines. 2021;9(8):872–97.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Tong JTW, Harris PWR, Brimble MA, Kavianinia I. An insight into FDA approved antibody-drug conjugates for cancer therapy. Molecules. 2021;26(19):5847–70.

Article  CAS  PubMed  PubMed Central  Google Scholar 

CDC. Hazardous Drugs: Draft NIOSH List of Hazardous Drugs in Healthcare Settings; 2020; Procedures; and Risk Management Information [Internet]. The National Institute for Occupational Safety and Health (NIOSH); 2020 May [cited 2020 June 19]. Available from: https://www.cdc.gov/niosh/docket/review/docket233c/default.html. Accessed 5 Dec 2023.

Vyas N, Yiannakis D, Turner A, Sewell GJ. Occupational exposure to anti-cancer drugs: A review of effects of new technology. J Oncol Pharm Pract. 2014;20(4):278–87.

Article  PubMed  Google Scholar 

Petoskey F, Kwok SC, Jackson W, Jiang S. Overcoming challenges of implementing closed system transfer device clinical in-use compatibility testing for drug development of antibody drug conjugates. J Pharm Sci. 2020;109(1):761–8.

Article  CAS  PubMed  Google Scholar 

Besheer A, Mahler HC, Matter-Schwald A, Barrenechea SM, Vogt M, Chalus P, Heymes P, Pillow T, Kirste A, Favrod P, Joerg S, Mathaes R. Evaluation of different quality-relevant aspects of Closed System Transfer Devices (CSTDs). Pharm Res. 2020;37(4):81–93.

Article  CAS  PubMed  Google Scholar 

Sumikawa S, Yakushijin Y, Aogi K, et al. Frequency and component analysis of contaminants generated in preparation of anticancer agents using closed system drug transfer devices (CSTDs). Sci Rep. 2022;12:139. https://doi.org/10.1038/s41598-021-03780-0.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Patke S, Gaillat EN, Calero-Rubio C, Gooding TB, Audat H, Leman M, Filipe V, Saluja A. A systematic approach to evaluating closed system drug-transfer devices during drug product development. J Pharm Sci. 2022;111(5):1325–34.

Article  CAS  PubMed  Google Scholar 

Sreedhara A, Zamiri C, Goswami S, Weiser S, Cram M, Christian TR, Jagannathan B. Challenges of using closed system transfer devices with biological drug products: an industry perspective. J Pharm Sci. 2020;109(1):22–9.

Article  CAS  PubMed  Google Scholar 

Besheer A, Burton L, Galas RJ Jr, Gokhale K, Goldbach P, Hu Q, Mathews L, Muthurania K, Narasimhan C, Singh SN, Stokes ESE, Weiser S, Zamiri C, Zhou S. An industry perspective on compatibility assessment of closed system drug-transfer devices for biologics. J Pharm Sci. 2021;110(2):610–4.

Article  CAS  PubMed  Google Scholar 

Miyake T, Iwamoto T, Tanimura M, Okuda M. Impact of closed-system drug transfer device on exposure of environment and healthcare provider to cyclophosphamide in Japanese hospital. Springerplus. 2013;2(1):273–80.

Article  PubMed  PubMed Central  Google Scholar 

Gopalrathnam G, Christian TR, Jagannathan B, Petoskey F, Kühnle B, Weiser S, Kagdi R, Saluja S, Bhattacharyya A, Burton L, Zamiri C, Hanley K. An industry perspective on the challenges of using closed system transfer devices with biologics and communication guidance to healthcare professionals. J Pharm Sci. 2021;110(6):2329–35.

Article  CAS  PubMed  Google Scholar 

Ross PL, Wolfe JL. Physical and chemical stability of antibody drug conjugates: current status. J Pharm Sci. 2016;105(2):391–7.

Article  CAS  PubMed  Google Scholar 

Duerr C, Friess W. Antibody-drug conjugates- stability and formulation. Eur J Pharm Biopharm. 2019;139:168–76.

Article  CAS  PubMed  Google Scholar 

Fedorowicz FM, Chalus P, Kirschenbühler K, Drewes S, Koulov A. Image classification of degraded polysorbate, protein and silicone oil sub-visible particles detected by flow-imaging microscopy in biopharmaceuticals using a convolutional neural network model. J Pharm Sci. 2023;112(12):3099–108.

Article  CAS  PubMed  Google Scholar 

Wozniewski M, Besheer A, Sediq AS, Huwyler J, Mahler HC, Levet V. Characterization of silicone from closed system transfer devices and its migration into pharmaceutical drug products. J Pharm Sci. 2023;S0022–3549(23):00485–9.

Google Scholar 

Winzer M, Besheer A. Administration of ADCs using CSTDs: Impacts on Drug Product Quality. Data presented at: PDA Parenteral Packaging Conference Basel. 2022. Switzerland.

Buecheler Jacob W, Winzer M, Tonillo J, Weber C, Gieseler H. Impact of payload hydrophobicity on the stability of antibody drug conjugates. Mol Pharm. 2018;15(7):2656–64.

Article  Google Scholar 

Li J, Pinnamaneni S, Quan Y, Jaiswal A, Andersson FI, Zhang X. Mechanistic understanding of protein-silicone oil interactions. Pharm Res. 2012;29(6):1689–97. https://doi.org/10.1007/s11095-012-0696-6.

Article  CAS  PubMed  Google Scholar 

Ludwig DB, Carpenter JF, Hamel JB, Randolph TW. Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions. J Pharm Sci. 2010;99(4):1721–33.

Article  CAS  PubMed  Google Scholar 

Chisholm CF, Baker AE, Soucie KR, Torres RM, Carpenter JF, Randolph TW. Silicone oil microdroplets can induce antibody responses against recombinant murine growth hormone in mice. J Pharm Sci. 2016;105(5):1623–32.

Article  CAS  PubMed  PubMed Central  Google Scholar