Search results for "Science"
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability.
Sep 2, 2014
By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…
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Challenges of Protein Aggregation During Purification
Liddell, head of process sciences with Fujifilm Diosynth Biotechnologies.
“Aggregate formation is generally dependent on the solution conditions (conductivity and pH), protein concentration, and t…
Article
Concentration and Diafiltration of Cell-Derived, Live Influenza Virus Using 750 C Hollow Fiber Filter Cartridge
Cross flow filtration (CFF) is a technique extensively used in vaccine production and particularly in influenza vaccine manufacturing. In contrast to normal flow (dead-end) filtration (NFF), the fee…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Ultimately, a clear picture of attribute criticality, followed by mapping of their linkages to process parameters, can enable well-justified, science-based control strategies that put the right contro…
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
Four experimental cocktail solutions composed of cDNA synthesis reaction and SABiosciences RT2 qPCR master Mix (Qiagen) were dispensed into 4 × 96 wells (10 µL/well) in 384-well PCR unfolded protein r…
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Challenges in Analytical Method Development and Validation
According to Yong Guo, professor of pharmaceutical sciences at the School of Pharmacy, Fairleigh Dickinson University (FDU), analytical development and cross-functional development teams should work t…
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Q&As with Industry Leaders
…nternational
Christopher Woolstenhulme, Lead Analytical Scientist of Manufacturing Sciences, Cytiva
Tools and Methodologies for Smarter Downstream Process Development
Gayle S. Pu…
Article
Biopharma Takes a Nervous Glance Over Its Shoulder
These factors include a competitive corporate tax rate; private funding of R&D in early stage and emerging companies; robust government investment in basic R&D; a strong R&D and science, technology, e…
Article
Raw Material Variability
For the manufacturers cross-functional teams covering operations, quality control, quality assurance, purchasing, and manufacturing science are now best practice to ensure all perspectives are taken i…
Article
Early Communication with Regulators is Essential for SMEs
“The people running SMEs know the science and technology of the area in which they are doing business,” explains Hooshang Zavareh, founder of ChemPharmServe, Cambridge England, a company that speciali…