Warning: Invalid argument supplied for foreach() in /home/customer/www/biophorum.com/public_html/wp-content/plugins/code-snippets/php/snippet-ops.php(484) : eval()'d code on line 136
China is a commercial market with enormous potential for the biopharmaceutical industry but is transitioning from a national regulatory environment to one that is more harmonized with the global industry (still with some local specifics and complexities). ...
Until now there has been no industry-wide empirical data on the technical practices involved in therapeutic protein production, nor any evaluation of if/how this changed in response to the COVID-19 pandemic. Furthermore, there is no industry-wide view on if/how any...
The objective of this survey was to gather feedback on two key areas: Company position as part of the initial submission Biologics License Applications (BLA) / Marketing Authorization Application (MAA) supplement/variation, etc.) Outcome of health authority review and...
The aim of ICH Q12 is clearly stated as a framework to facilitate the management of post-approval CMC changes. The biopharmaceutical industry through these comments commends the agency on leading the way to the implementation of ICH Q12. The BioPhorum comments are...
Many companies have increasingly sought to outsource chemistry, manufacturing, and controls (CMC) development services. Successful outsourcing has many benefits, such as meeting increased demand, reducing the time to market and improving capacity. However, BioPhorum...
