Search results for " attribute" in Articles / App Notes
Article
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
Article
The Bullish Outlook for Biosimilars
Medical Affairs functions will have an important role to play in educating opinion leaders around product nomenclature, product attributes, and comparisons to reference drugs. Following a product laun…
Article
Technologies and Practices Must Evolve to Meet Demand
More than 65% attributed the increase in manufacturing capacity or services to new products.
Spending on biopharmaceutical manufacturing equipment and services was up compared to 2013; 52.5% repor…
Article
Securing the Single-Use Supply Chain
Focusing on the product attributes, quality, and specifications may not be enough, however, as there are other steps involved such as sterilization and transportation (sometimes international) that ma…
Article
Trends in Single-use Bioreactors
Recent studies have shown that this can be attributed to a degradation product of a commonly used antioxidant.
Establishing full traceability of raw materials, robust process controls, and meaning…
Article
Setting Standards for Biotech Therapeutics in India
The certificate of analysis should be submitted and should include the critical quality attributes with respect to identity, content, and potency of the product. Stability of the material should be al…
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Third is increased focus on relating the quality attributes of a biotech product to its clinical safety and efficacy. Fourth is the extension of the QbD concepts from the traditional process developme…
Article
Challenges of Protein Aggregation During Purification
“If aggregation happens spontaneously during the process,” adds Jagschies, “it is not so much the attribute of one of the steps used for purification, but of the protein that is being purified (i.e., …
Article
Relationship Building at Top of Mind for Clients
Annual study shows technical expertise is not enough.
Aug 1, 2014
By: Eric Langer
BioPharm International
Volume 27, Issue 8, pp. 12-14
Contract manufacturing organizations (CMOs) shou…
Article
Single-Domain Antibodies for Brain Targeting
In contrast to common antibodies, two out of six sdAb survived a temperature of 90 C without losing their ability to bind antigens (21), a property that is attributed to a reversible unfolding behavio…