TLA: Improved genetic characterisation and clonality assessment for (CHO) cell line development
An important objective in product supply is to minimize cell bank heterogeneity for the consistent production of biologics. On this note, TLA helps determine the entire genetic makeup of your master cell bank (MCB) in a rapid and cost-effective manner. More importantly, we offer detailed reporting suitable for use in the regulatory application for pharmaceuticals for human use, according to FDA and EMA expectations (ICH guidelines Q5B and Q5D; CTD Quality module, section 3.2.S.2.3).
Highlights of this webinar include:
- Advantages of TLA over conventional technologies
- Our extensive experience in supporting and/or publishing with various leading pharmaceutical companies globally
- Principles of TLA
- Relevance of TLA in (CHO) cell line development
- Detailed study reports meeting FDA expectations
- Whitepaper with Novartis
For an overview of the publications cited in the presentation, click here.
Please contact us for more information.