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

Journal of Pharmaceutical Sciences

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

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).

https://linkinghub.elsevier.com/retrieve/pii/S0022354923004847