PROJECT 4: Quality Assurance/ Quality Control and Standards

Test-Beds Involved: All

In order to achieve robust predictions of cell potency and safety in manufacturing, we need to establish robust QA/QC and standards that can be used both in CMaT and the broader manufacturing community.

Aim 1: Formalize specific QA/QC protocols for NMR and LC-MS that are appropriate for the sample sizes and types in CMaT.

Aim 2: Establish an intermediate external reference standard that can serve as a reference material for batch normalization until more robust material is developed (Aim 3).

Aim 3: Develop cell-specific reference material with NIST partners.