Search results for " methods" in Articles / App Notes
Article
Setting Standards for Biotech Therapeutics in India
The scope of the lab includes:
Development/verification of methods and limits for biological monographs
Development of IP reference standards for biotech therapeutics
The success of these …
Article
Application of Quality by Design to Viral Safety
For companies with robust pipelines using closely related manufacturing methods and similar starting materials, some unit operations may be amenable to thorough characterization, developing an operati…
Article
Challenges of Protein Aggregation During Purification
coli-based processes may be a target for such methods, because the aggregation that occurs in inclusion bodies has proven difficult and costly to manage.
Reference
1. Z. Yu et al., J. Pharm. S…
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
Designed experiments, using well-characterized test articles and advanced analytical methods, can help resolve uncertainties surrounding attribute criticality. Ultimately, a clear picture of attribute…
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
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…
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…