Building GMP-Ready Assays from Day One – Analytical Planning for Success

Time: 9:00 am
day: Conference Day 1 Morning

Details:

• Employ analytical planning to give yourself a head start: Defining analytical assays with a mind of scalability and translation before assay work begins aligns teams around clear performance goals. A shared blueprint prevents rework and ensures data are validation-ready from the start.
• Standardize early: Setting hardware, software, and reagent choices early removes variability. Smart Gain and StainExpress™ technologies make multi-site transfer seamless and can cut weeks from qualification.
• Define a team as your analytical bridge to GMP: A defined team translates R&D knowledge into GMP execution through risk-based design and complete SOPs. A structured approach can significantly shorten IND preparation.

Speakers:

Victoria Diersen Victoria Diersen is the Analytical Method Development Manager within the Process Development group at Lentigen Technology, Inc., a Miltenyi Biotec company. With more than a Read more