title: Studies on the use of needle-free injection device on proteins.
abstract: In the following communication we report the evaluation of 18 proteins that were processed by a specific needle free injection device. The processed protein samples were analyzed by two HPLC techniques, reversed-phase liquid chromatography (RPLC) and size-exclusion chromatography (SEC). These techniques are two of the most widely used analytical techniques in the biopharmaceutical industry for the characterization, integrity assessment and stability study of peptide and protein products. The results indicate that needle free injection, using the specific device of this study, is not damaging to the studied proteins and does not generate aggregates. We found no evidence of the predicted possible effects of needle free injections, and concluded that needle free delivery is in general not different than any other delivery system and that its use should be evaluated on a case by case basis. It has to be noted that there are various needle free device designs and our work was performed using an Iject from Bioject. Our conclusions therefore should be limited to the Iject design we used in this study. In the reported experiments we used commercially available (economical) model proteins, which facilitate the use of the results for future comparison and reference. The work reported here can serve as a reference to illustrate the benign nature of our needle free injection device. It also highlights an interesting analogy between a set of phobias that were seen to have plagued the early stages of biochemistry and HPLC, on the one hand, and some attitudes that appear to hinder the widespread acceptance of needle free injection at present time, on the other. These phobias were identified and named by Professor Csaba Horváth, the father of HPLC, as barophobia, siderophobia and lithophobia. Today a wealth of evidence is available to indicate that those phobias are ungrounded and that the negative observations can be explained in most cases by adsorption and prevented by proper formulations and solvent conditions.
authors.affiliation: iGORi, 1543 N. Moorpark Road No. 319, Thousand Oaks, CA 91360, USA. kbenedek@igori.com
authors.forename: Kálmán
authors.initials: K
authors.lastname: Benedek
authors.forename: Ekaterina
authors.initials: E
authors.lastname: Walker
authors.forename: Lonnie A
authors.initials: LA
authors.lastname: Doshier
authors.forename: Richard
authors.initials: R
authors.lastname: Stout
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D016503:Drug Delivery Systems; D004355:Drug Stability; D006031:Glycosylation; D007267:Injections / Q000379:methods*; D009339:Needles; D011506:Proteins / Q000008:administration & dosage / Q000032:analysis* / Q000378:metabolism
chemical_list: D011506:Proteins