Search results for " pure"
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
The problem with this method would be obtaining sufficient quantities of pure isolated variants, as some of the variants may be present in a small amount and merge with other variants.
Step 4: M…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Today, healthy mammalian cell cultures are commonly grown in protein-free, chemically-defined media that contain only 60-70 pure components, none of which come from animals or are even exposed to anim…
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Process Chromatography Selection for Downstream Processing Applications
Large columns at high flowrates need adequate piping and both pure water and wastewater systems must be sized to handle the demand. If onsite systems cannot meet the needs for buffer and cell-culture …
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Aseptic Processing: Keeping it Safe
Chua, “Pharma’s thirst for pure, clean water,” www.eco-business.com/news/pharmas-thirst-for-pure-clean-water/, accessed May 22, 2015.
6. R.W. Acucena, “Defining a Strategy for the Validation and Q…
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ÄKTA Laboratory-Scale Chromatography Systems Handbook
This handbook is focused on liquid chromatography systems used for protein purification at research laboratory scale. Beginners can use the handbook to obtain an overview of how purification systems…
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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
Fermentation for the Future
Improving efficiency, value chain, quality, and protein complexity with advanced bioprocess development.
Jan 01, 2015
By Cynthia Challener, PhD
Microorganisms—bacteria and yeast—have b…
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
The synthetic DNA vaccines are produced in pure water and do not contain any live virus, parts of a virus, adjuvants, or preservatives and are thermostable (i.e., no cold-chain requirements). The DNA …
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
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Regulatory Challenges in the QbD Paradigm
… strive for continuous improvement to reach the desired end point of consistent, safe and effective, pure and potent, drug products. They share this knowledge with FDA. The agency develops the expert…