Search results for " production" in Articles / App Notes
Article
Biosimilars: Making the Switch Comes with Challenges
Yet both regulators and producers believe that more could be done to eliminate uncertainties about biosimilars by making improvements at the production and preclinical stages, for example by implement…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
This article covers cleaning validation of equipment dedicated to the production of a single API; equipment used for manufacturing a class of products (e.g., penicillins) should be considered as share…
Article
The Bullish Outlook for Biosimilars
Feb 01, 2015
By Jill E. Sackman, PhD, Michael J. Kuchenreuther, PhD
BioPharm International
There are several important reasons for stakeholders to be optimistic about prospects for b…
Article
Viral Clearance Challenges in Bioprocessing
One major concern for biologics production is the entry of a small, non-enveloped, chemically resistant virus into the manufacturing system, according to Zhou. “Good facility design and strict complia…
Article
Challenges of Protein Aggregation During Purification
“Dynamic light scattering, which is a non-perturbing technology, has, for example, been used to monitor inclusion body solubilization, protein refolding, and aggregation near the production line of a …
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…
Article
Implementing QbD in Sterile Manufacturing
…s the most adequate product and process-fitting filling pumps, can be used right away for subsequent production.
Challenges in implementing QbD
BioPharm: What are the chal…
Article
Trends in Downstream Bioprocessing
• Current downstream/purification areas were not designed to handle this increase in production.
• Buffer capacity, column size, UF membrane area are all problems.
• Primary clarification is a…
Article
Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…