Search results for " serum"
Article
Scalable Viral Vector Manufacturing
From a regulatory perspective, it is recommended to avoid any raw materials that are of animal origin such as serum and other components as these could potentially contain adventitious agents.
Is …
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Co-migrating isomers are especially evident in complex samples such as serum (3) or plasma (4), in which a single UHPLC-FLR peak may contain over five glycan species with the same mass. In all samples…
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Concentration and Buffer Exchange Using the Automated, Single-Use ÄKTA™ readyflux System
This work describes the capabilities of ÄKTA readyflux when used in ultrafiltration/diafiltration (UF/DF) applications. The process was conducted in an automated manner based on methods created …
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The New World of Biopharmaceutical Manufacturing
…t 40 years, single-use systems have moved from simple blood and intravenous bags to simple media and serum containers, and to highly engineered, complex devices that are now mainstream technologies i…
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N-Glycan Analysis of Biotherapeutic Proteins
LC-ESI-MS has also been used to analyze the glycosylation of erythropoietin (EPO), including darbepoetin alfa, an EPO analog with two additional N-linked glycan sites and a longer serum half-life (27)…
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Witnessing Major Growth in Next-Generation Antibodies
Nanobodies are based on naturally occurring heavy-chain-only antibodies first discovered in the serum of camelids and, according to de Fougerolles, upon sequence optimization and humanization maintain…
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Selecting a Comprehensive Bioburden Reduction Plan
…ocess formulations, viruses and mycoplasma are typically only encountered in formulations containing serum or animal, plant, or insect cell lines. The selection of specific microporous membrane filte…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
Mar 01, 2015
By Randi Hernandez
BioPharm International
Volume 3, Issue 28
Aggregation in biopharmaceuticals remains a major concern and threatens the stability of a product. Protein …
Article
Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh
BioPharm Inter…
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Biopharma Manufacturers Respond to Ebola Crisis
DOD research agencies have supported development of this process for “infecting” tobacco plants with an anti-viral protein that then can be extracted and processed into a purified serum. There has bee…