These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: Excipients for Room Temperature Stable Freeze-Dried Monoclonal Antibody Formulations.
    Author: Haeuser C, Goldbach P, Huwyler J, Friess W, Allmendinger A.
    Journal: J Pharm Sci; 2020 Jan; 109(1):807-817. PubMed ID: 31622600.
    Abstract:
    Sucrose is a common cryoprotectant and lyoprotectant to stabilize labile biopharmaceuticals during freeze-drying and storage. Sucrose-based formulations require low primary drying temperatures to avoid collapse and monoclonal antibody (mAb) containing products need to be stored refrigerated. The objective of this study is to investigate different excipients enabling storage at room temperature and aggressive, shorter lyophilization cycles. We studied combinations of 2-hydroxypropyl-beta-cyclodextrin (CD), recombinant human albumin, polyvinylpyrroldione (PVP), dextran 40 kDa (Dex), and sucrose (Suc) using 2 mAbs. Samples were characterized for collapse temperature (Tc), glass transition temperature of the liquid (Tg') and freeze-dried formulation (Tg), cake appearance, residual moisture, and reconstitution time. Freeze-dried formulations were stored at 5°C, 25°C, and 40°C for up to 9 months and mAb stability was analyzed for color, turbidity, visible and sub-visible particles, and monomer content. Formulations with CD/Suc or CD/PVP/Suc were superior to pure Suc formulations for long-term storage at 40°C. When using aggressive freeze-drying cycles, these formulations were characterized by pharmaceutically elegant cakes, short reconstitution times, higher Tg', Tc, and Tg. We conclude that the addition of CD allows for shorter freeze-drying cycles with improved cake appearance and enables storage at room temperature, which might reduce costs of goods substantially.
    [Abstract] [Full Text] [Related] [New Search]