Search results for " plasma"
Article
Affinity chromatography Handbook - Vol. 3: Specific Groups of Biomolecules
Affinity chromatography (AC) separates proteins on the basis of a reversible interaction between a protein (or group of proteins) and a specific ligand coupled to a chromatography matrix. The techni…
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Biopharma in 2015: A Year for Approvals and Innovations
…n capacity using single-use versus stainless steel fermentation equipment
A Bright Future for the Plasma Fractionation Industry
Defining Critical Quality Attributes for Monoclonal Antibody Ther…
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Ensuring the Quality of Biologicals
Biologicals are those products derived from biological sources such as tissues and cell extracts, fermentation using micro-organisms, plasma, plants, or those produced by recombinant DNA technology. T…
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Quality by Design and Extractable and Leachable Testing
These extracted chemicals are then identified by various analytical techniques, typically inductively coupled plasma mass spectrometry (ICP—MS), liquid chromatography-mass spectrometry (HPLC–MS), and …
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Challenges in Analytical Method Development and Validation
For example, for blood or blood plasma products, validation of potency and some safety test methods is expected much earlier (clinical Phase 1). For most other products, method validation is typically…
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Bioprocessing Advances in Vaccine Manufacture
Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.
The vaccine industry, particularly, in major Western markets, continues to be dominated by a few majo…
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Milestones and Moderate Progress in 2012 Drug Approvals
It is approved for treatment of toxic plasma methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function. Methotrexate is an anti-folate antimetabolite w…