The effect of mAb and excipient cryoconcentration on long-term frozen storage stability – part 2: Aggregate formation and oxidation

Autor: Bluemel, Oliver, Buecheler, Jakob W., Hauptmann, Astrid, Hoelzl, Georg, Bechtold-Peters, Karoline, Friess, Wolfgang

Publikováno v: In International Journal of Pharmaceutics: X December 2022 4

Evaluation of Two Novel Scale-Down Devices for Testing Monoclonal Antibody Aggregation During Large-Scale Freezing

Autor: Bluemel, Oliver, Rodrigues, Miguel A., Buecheler, Jakob W., Geraldes, Vitor, Hoelzl, Georg, Hauptmann, Astrid, Bechtold-Peters, Karoline, Friess, Wolfgang

Publikováno v: In Journal of Pharmaceutical Sciences July 2022 111(7):1973-1983

Tento výsledek nelze pro nepřihlášené uživatele zobrazit.
K zobrazení výsledku je třeba se přihlásit.

The effect of mAb and excipient cryoconcentration on long-term frozen storage stability - Part 1: Higher molecular weight species and subvisible particle formation.

Autor: Bluemel O; Pharmaceutical Technology and Biopharmaceutics, Department of Pharmacy, Ludwig-Maximilians-Universitaet Muenchen, 81377 Munich, Germany., Anuschek M; Pharmaceutical Technology and Biopharmaceutics, Department of Pharmacy, Ludwig-Maximilians-Universitaet Muenchen, 81377 Munich, Germany., Buecheler JW; Technical Research and Development, Novartis Pharma AG, 4002 Basel, Switzerland., Hoelzl G; Sandoz GmbH, 6336 Langkampfen, Austria., Bechtold-Peters K; Technical Research and Development, Novartis Pharma AG, 4002 Basel, Switzerland., Friess W; Pharmaceutical Technology and Biopharmaceutics, Department of Pharmacy, Ludwig-Maximilians-Universitaet Muenchen, 81377 Munich, Germany.

Publikováno v: International journal of pharmaceutics: X [Int J Pharm X] 2021 Dec 25; Vol. 4, pp. 100108. Date of Electronic Publication: 2021 Dec 25 (Print Publication: 2022).