Use of Closed System Transfer Devices (CSTDs) with Protein-Based Therapeutic Drugs—A Non-Solution for a Non-Problem?

Journal of Pharmaceutical Sciences

Jonas Fast, Twinkle Christian, Mirjam Crul, Wim Jiskoot, M. Reza Nejadnik, Annette Medina, Allison Radwick, Alavattam Sreedhara, Hugh Tole

Use of Closed System Transfer Devices (CSTDs) with Protein-Based Therapeutic Drugs—A Non-Solution for a Non-Problem?

Protein-based therapeutics like monoclonal antibodies (mAbs) have revolutionized the treatment of diseases for the last four decades with the number of approved protein-based therapeutics along with their sales figures steadily increasing. General advantages of protein-based therapeutics compared to small molecule drugs include their limited off-target potency and their relative benign safety profiles. However, protein-based therapeutics face numerous biological and biopharmaceutical challenges that limit their routes of administration, with a few exceptions, to parenteral administration rather than less invasive and convenient routes (e.g., oral).

Journal of Pharmaceutical Sciences

https://doi.org/10.1016/j.xphs.2023.11.014

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