Search results for " method"
Article
Setting Standards for Biotech Therapeutics in India
The detailed study testing protocol should include validated method to be followed for analytical testing, storage, and handling along with the procedures for reporting and submission of results.
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Article
Application of Quality by Design to Viral Safety
However, the benefits include operational flexibility, as future modifications to the purification method that remain within the process design space are not considered changes and do not require addi…
Article
Challenges of Protein Aggregation During Purification
Choosing other conditions or a different method for purification usually helps to avoid the problem.”
Advances in affinity technology are also helping to address some aggregation issues. For examp…
Article
Evaluating Design Margin, Edge of Failure and Process
There are six primary statistical methods to define process capability. They are all convertible from one measure to another (see Table I):
Yield and/or Failure Rate--Data type: Pass/Fail (Categor…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
To study the effects of glycan structure on the clearance of an Fc receptor fusion protein, an affinity extraction method was developed that could specifically recover the drug from cynomolgus monkey …
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
Materials and methods
Cell lines. Three recombinant Chinese hamster ovary (CHO) cell lines, developed in-house to produce three different monoclonal antibodies, were used in this study. Cell li…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
…h post-approval changes to QbD processes, and the need for international harmonization of assessment methods. Regulators at the meeting complained that one big difficulty comes from the differences i…
Article
Evolution of the Monoclonal Antibody Purification Platform
Anion exchange (AEX) chromatography in a flow-through mode is the method of choice for removal of host-cell impurities. Hydrophobic-interaction chromatography (HIC) in bind and elute mode has been use…
Article
QbD and PAT in Upstream and Downstream Processing
… biologic API manufacturing?
Girard (Spinnovation): FDA identified the use of new analytical methods, such as nuclear magnetic resonance (NMR), to monitor and control processes as important i…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
For each product under development, an initial assessment of available knowledge regarding the product and its function is assessed using various methods such as previous experience, literature inform…