Resources | Advanced instruments

Assurance of Clonality: a key regulatory requirement for biotherapeutics

Clonal derivation of cell lines used in biotherapeutics manufacturing is a critical quality attribute and a requirement for regulatory submission. State-of-the art technologies can help you optimize the isolation of single cells and provide the proof of clonality health authorities require.

In this White Paper, you will learn:

  • why clonality is a key requirement for regulatory submission
  • what are the limits of traditional approaches to subcloning
  • what are the advantages of innovative low-pressure automated seeding methods
  • how modern high-quality imaging methods provide the proof of clonality you need for clonality assurance and increase your workflow efficiency