Search results for " attribute"
Article
Host-Cell Protein Measurement and Control
The amount of residual HCPs in drug product is generally considered a critical quality attribute (CQA), due to their potential to affect product safety and efficacy. Therefore, it is a regulatory requ…
Article
Modular Manufacturing Platforms for Biologics
…m processing structures can be deployed and redeployed rapidly without compromising required quality attributes.”
Cleanroom pods can be used for entire process streams, as in the Caliber example,…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Such standards will aim to capture critical product attributes that can indicate quality problems, needed corrective actions, and justify enforcement decisions. OPQ’s Office of Policy for Pharmaceutic…
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…