Overcoming Challenges With Intravenous Administration of an Investigational Protein Therapeutic

Piggyback infusion has been widely used in the clinic with most applications in a nonconcurrent fashion for the purpose of administration convenience. In the present study, we demonstrated the application of concurrent piggyback to overcome challenges with intravenous administration of a salt-sensitive investigational protein. This setup consists of a syringe line containing drug admixture prepared in water-for-injection which is connected to a 0.9% sodium chloride line to keep vein open. Both lines are pump controlled and run concurrently at corresponding flow rate. The admixture compatibility study was conducted in 2 stages. In the first stage, admixture (concentration range from 0.05 to 2.0 mg/mL) was demonstrated to be compatible with water-for-injection and administration materials, such as intravenous bag, syringe, and syringe infusion line, for at least 24 h at room temperature. In the second stage, steady-state admixture concentration was demonstrated approximately 10 min after mixing even at the slowest syringe infusion rate. No loss of protein concentration was observed after reaching steady-state infusion. Subvisible particulates before and after piggybacking mixing are found well within the acceptable range.