Faculty Opinions recommendation of Managing uncertainty: a perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins.

2019 ◽  
Author(s):  
David Hayes
Keyword(s):  
Product Quality ◽  
Therapeutic Proteins ◽  
Quality Attributes

scholarly journals Tunable Protein Crystal Size Distribution via Continuous Slug-Flow Crystallization with Spatially Varying Temperature

CrystEngComm ◽  
2021 ◽  
Author(s):  
Nicholas Mozdzierz ◽  
Moo Sun Hong ◽  
Yongkyu Lee ◽  
Moritz Benisch ◽  
Mo Jiang ◽  
...  
Keyword(s):  
Product Quality ◽  
Size Distribution ◽  
Slug Flow ◽  
Crystal Size ◽  
Quality Attributes ◽  
Crystal Size Distribution ◽  
Protein Crystal ◽  
Manufacturing Cost ◽  
Spatially Varying

Accompanied with the growth of the biopharmaceuticals market has been an interest in developing processes with increased control of product quality attributes at low manufacturing cost, with one of the...

scholarly journals New Opportunities in Glycan Engineering for Therapeutic Proteins

Antibodies ◽  
2022 ◽  
Vol 11 (1) ◽  
pp. 5
Author(s):  
Xiaotian Zhong ◽  
Aaron M. D’Antona ◽  
John J. Scarcelli ◽  
Jason C. Rouse
Keyword(s):  
Fusion Proteins ◽  
Therapeutic Proteins ◽  
Quality Attributes ◽  
Efficacy And Safety ◽  
Biological Functions ◽  
Next Generation ◽  
Lysosomal Degradation ◽  
Critical Quality Attributes ◽  
Recombinant Fusion Proteins ◽  
Antibody Diversification

Glycans as sugar polymers are important metabolic, structural, and physiological regulators for cellular and biological functions. They are often classified as critical quality attributes to antibodies and recombinant fusion proteins, given their impacts on the efficacy and safety of biologics drugs. Recent reports on the conjugates of N-acetyl-galactosamine and mannose-6-phosphate for lysosomal degradation, Fab glycans for antibody diversification, as well as sialylation therapeutic modulations and O-linked applications, have been fueling the continued interest in glycoengineering. The current advancements of the human glycome and the development of a comprehensive network in glycosylation pathways have presented new opportunities in designing next-generation therapeutic proteins.

Online/at‐line measurement, analysis and control of product titer and critical product quality attributes (CQAs) during process development

2020 ◽  
Vol 117 (12) ◽  
pp. 3757-3765 ◽  
Author(s):  
Letha Chemmalil ◽  
Tanushree Prabhakar ◽  
June Kuang ◽  
Jay West ◽  
Zhijun Tan ◽  
...  
Keyword(s):  
Product Quality ◽  
Process Development ◽  
Quality Attributes ◽  
Product Titer ◽  
Measurement Analysis ◽  
Line Measurement ◽  
And Control
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