RNA Critical Process Parameters
This workstream will identify common critical process parameters (CPPs) that align with critical quality attributes for mRNA/LNP products that can be used as an industry standard. It will also investigate whether a common standard can be defined for in-process controls (IPCs) and acceptable quality limits (AQLs) to support risk-based quality control strategies for mRNA development and commercial manufacturing.
There is no guidance for identifying critical process parameters for process variables that impact on critical quality attributes for mRNA products
There are no frameworks or industry regulations/guidance on the critical process parameters for developing robust manufacturing processes for mRNA products. Some mRNA products can have very small batch sizes resulting in a disproportionate amount of batch taken for testing of manufacturing quality.
Enabling faster selection of critical process parameters and reducing development time
By providing a reference for industry with justified critical process parameters aligned with critical quality attributes that will support robust mRNA process development and commercial manufacturing, this workstream will decrease process development time.
RNA Critical Process Parameters deliverables
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