Search results for " attribute" in Articles / App Notes
Article
Applying GMPs to the BioPharma Supply Chain
Elimination and control of sources of variation
Suppliers need to understand how variability in the manufacturing process affects the quality attributes of their product. They need to have tools t…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
The surfactant addition to the feed did not have any impact on measured protein quality attributes.
Medium storage stability is a general concern for manufacturing and development using concentrat…
Article
Biopharma Takes a Nervous Glance Over Its Shoulder
The report identified 10 attributes necessary to "advancing a more favorable business operating environment" in the United States. These factors include a competitive corporate tax rate; private fundi…
Article
Design of Experiments for Analytical Method Development and Validation
…accuracy, linearity, signal to noise, limits of detection and quantification, and/or any other assay attributes to achieve optimal assay results.
DOE for Method Development
Design of ex…
Article
Brazil Emerges as Global Biopharm Collaborator
In terms of R&D, for example, challenges are attributed to the country’s lack of technological capacity to produce relevant innovation, says Guimarães.
The Brazilian government through its Heal…
Article
Predicting Progress in Protein Aggregation
“The idea is to match specific amino acid sequences (and structural features) within proteins to the probability of aggregation by comparing their physicochemical and structural attributes to those of…
Article
Evolution of the Monoclonal Antibody Purification Platform
Some process development related attributes with respect to production of mAbs include:
• Significant increase in titer levels over the past decade (from 0.5 mg/mL to 5-10 mg/mL)
• High pr…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…
Article
Flexibility in Biopharmaceutical Manufacturing
Flexibility is another must-have attribute, and although everyone wants it, you're likely to get a wide spectrum of definitions when you ask what it is.
With such a diverse view on what flexibi…
Article
Advancing QbD in the EU
…uality assurance or an "enhanced" structured approach, which involves concepts like critical quality attributes (CQA), design space, and control strategies.
The industry has been urging EU aut…