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IN-LINE FILTER FOR PROTEIN/PEPTIDE DRUG ADMINISTRATION
专利权人:
LUPIN LIMITED
发明人:
DEVARANENI, PRASANNA KUMAR,MODY, RUSTOM SORAB
申请号:
CA3037114
公开号:
CA3037114A1
申请日:
2017.09.19
申请国别(地区):
CA
年份:
2018
代理人:
摘要:
The present invention relates to incorporation of in-line filter into the drug administration device to minimize the entry of particulates into the human body during injection of therapeutic proteins/peptides. Particulate matter can be of non-proteinaceous and/or proteinaceous and/or mixture thereof. Particles such as undissolved or precipitated solids, fibers, glass flakes, rubber fragments, silicone oil etc. represent non proteinaceous particles while protein aggregates (amorphous and fibrils) represent proteinaceous particles. Although particulate matter in injectable formulation required to be controlled within various regulatory and compendial limits, methods to mi nimize particulate matter further are beneficial as proteinaceous particulates poses the risk of immunogenicity.
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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