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Method to Determine Syringe Silicone Oil Layer Heterogeneity and Investigation of its Impact on Product Particle Counts

  • Published:2020-11 Issue:11 Volume:109 Page:3292-3299
  • ISSN:0022-3549
  • Container-title:Journal of Pharmaceutical Sciences
  • language:en
  • Short-container-title:Journal of Pharmaceutical Sciences

Author:

Cua Michelle,Martin Daniel,Meza Patricia,Torraca Gianni,Pearson Thomas,Cao Shawn,Yang Changhuei

Funder

Amgen, United States

Natural Sciences and Engineering Research Council of Canada, Canada

Predoctoral Biotechnology Leadership Training from the National Institute of Health

Donna and Benjamin M. Rosen Bioengineering Center Fund

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference22 articles.

1. Prefilled syringes: an innovation in parenteral packaging;Makwana;Int J Pharm Invest,2011

2. Silicone-oil-based subvisible particles: their detection, interactions, and regulation in prefilled container closure systems for biopharmaceuticals;Felsovalyi;J Pharm Sci,2012

3. Distribution of silicone oil in prefilled glass syringes probed with optical and spectroscopic methods;Wen;PDA J Pharm Sci Technol,2009

4. Silicone oil induced aggregation of proteins;Jones;J Pharm Sci,2005

5. Effect of the siliconization method on particle generation in a monoclonal antibody formulation in pre-filled syringes;Gerhardt;J Pharm Sci,2015
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