Posted on: 13th December 2017
Development Group’s CMC Considerations for Expedited Development Point Share team will be sharing their abstract, which has just been submitted to the CASSS WCBP for presentation at the meeting taking place in Washington, USA over 30 and 31 January 2018.
Companies are increasingly facing the challenge of taking risk-based approaches to CMC development for products in accelerated scenarios. This team has spent much of this year sharing and consolidating their approaches. The Washington meeting will provide the first opportunity for the team to gain some external input from both regulatory authorities and other biomanufacturers on their conclusions.You can access the abstract here