The paper is now available through the PDA and it is hoped that it will be an important offering to the industry when it comes to demonstrating monoclonality and will be a strong piece of the evidence when it comes to a company justifying their approach to the regulators, particularly the FDA.
“The purpose of the manuscript is to bring together a large consortium of companies that produces biologics and advance a position to regulators and other companies regarding the best technology to demonstrate monoclonality,” said David Shaw, Senior Scientist at Genentech. During the past 1-2 years, the Monoclonality point share has been busy creating a manuscript to promote its consensus.
Whilst the work to draft the manuscript was ongoing the team tested their position at several conferences. The first was back in 2015 at the Annual Cell Culture and Bioprocessing Congress in London. In 2018 the team continued this with further presentations at the Bioprocess International West Conference, San Francisco (Amie Lundquist – Shire), Cell Line Development and Engineering, San Francisco – KNect365 (Anke Mayer-Bartschmid – Bayer) and finally at the BioProduction 2018 – Cell Line Development and Engineering Symposium (Amie Lundquist – Shire). So far, the team have received some excellent feedback received and it was encouraging to witness a company at one of the conferences demonstrating their work, using their “real-life” data utilising the statistical approaches developed by the team.
The manuscript describes how to establish an imaging-based workflow, the mechanisms to verify the performance of an imager, and details a number of case studies. It walks the reader through the technical detail that they can consider when using imager based technologies including the detailed statistical evaluation that can be performed to ensure a robust package is built around the technology in order to support its use when it comes to demonstrating that a companies cell lines are monoclonal.
You can access the paper here