Search results for " growth"
Article
Raw Material Variability
Common examples would be out of specification for a product critical quality attribute (CQA), slower cell growth, low titer, and evidence of extraneous matter following visual inspection.
Fixing…
Article
EMA Collaborates with HTA Assessment Networks
Within less than two years, biosimilar somatropin, the growth hormone, rose from a market share of around 20% in the country to over half.
In Germany, one of Europe’s biggest markets for biosimilar…
Article
2014 Manufacturing Trends and Outlook
The responses indicate some signs of manufacturing growth. More than half of all respondents said their companies increased biomanufacturing capacity in 2013. Less than 3% reported a drop in productio…
Article
Elucidating Biosimilars Characterization
The growth corresponds to a 20% increase from last year’s figures and accounts for approximately 2% of the overall biologics market. Although narrowly focused on only a small number of therapy areas a…
Article
Regulatory Challenges in the QbD Paradigm
…
• Risk assessments
• Process vulnerabilities to microbial contamination
• Microbial growth potential of product and other process solutions
• Impact of microbial contamination on proce…
Article
Flexibility in Biopharmaceutical Manufacturing
Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.
By: Simon Chalk
BioPharm International
There is a high degree of consensus in the biomanuf…