Search results for " attribute" in Articles / App Notes
Article
Understanding Validation and Technical Transfer, Part 3
International Council for Harmonization (ICH) Q8(R2) is an excellent source of information about linking material attributes and process parameters with drug product CQAs (6).
It stands to reas…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Target/ligand binding is an essential critical quality attribute (CQA) that needs to be monitored. The enzyme-linked immunosorbent assay (ELISA) is often used to assess ligand binding; however, it is …
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
This process helps in identifying the critical quality attributes (CQA) and is a joint effort between the client and the CMO.
CQA. CQAs are defined through execution of a risk assessment, which ev…
Article
Digitalization: The Route to Biopharma 4.0
Digitalization in process development
For any production process, there are two key attributes, namely scientific knowledge and technical know-how. Scientific knowledge comprises process developme…
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Due to its bioprocess-associated variability and impact on safety, pharmacokinetics, and pharmacodynamics, glycosylation is widely regarded as a critical quality attribute (CQA) of TGPs (1).
In th…
Article
Understanding Validation and Technical Transfer, Part I
…ic process will consistently produce a product meeting its pre-determined specifications and quality attributes” (5).
In 2000, ICH Q7A defined validation as, “A documented program that provide…
Article
Bioburden Control in the Biopharmaceutical Industry
Cundell, “Comparison of Microbiological Testing Practices in Clinical, Food, Water and Pharmaceutical Microbiology in Relation to the Microbiological Attributes of Nutritional and Dietary Supplements”…
Article
Going Small to Achieve Success on the Commercial Scale
The impact of QbD and DoE
The quality-by-design (QbD) approach to process development requires characterization of the impacts of different process parameters on product critical quality attribute…
Article
The Metrics of Quality Culture
Critical quality attributes. The third quality-culture optional metrics involves trying to use critical quality attributes (CQA) as a key indicator of a quality culture. Of the three optional metrics …
Article
Aseptic Processing: Keeping it Safe
The large-scale meningitis outbreak in 2012 has been attributed to poor aseptic processes, when contaminated vials in lots of preservative-free methylprednisone acetate sickened 751 people and killed …