Project: Standards for replication competent retrovirus (RCR) testing.
TYPE: STANDARDS ADVANCEMENT PROJECT
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DESCRIPTION:
Both retroviruses and lentiviruses, a subset of retroviruses, are used as vectors to treat genetic diseases by mapping a modified, healthy genome onto the DNA structure of a host’s cells. These vectors are designed to be self-limiting but in certain cases can be generated with self-replication competence during the manufacturing process. Uncontrolled viral replication can lead to adverse outcomes such as the development of tumors. RCR testing is therefore a requirement for both vector products and ex vivo cell therapy products that utilise vectors at multiple stages of manufacture as well as for patient monitoring after treatment.. Though general principles for RCR testing do exist, they are not adequately tested to be sufficient to guarantee long-term safety.
Standard Objective
SCB organized a feasibility assessment meeting on RCR Testing and is now coordinating a working group to draft a standard that provides a framework for the design, selection and validation of fit-for-purpose RCR and replication competent lentivirus (RCL) testing methods in vectors and transduced cell products with application to user-specific product development.
Potential Areas to Standardize
Testing needs specific to lentiviruses and other common vectors (e.g., adeno-associated viruses [AAVs])
Specific testing requirements at each production process step
Test method selection and validation framework
Protocol for patient monitoring after infusion
Appropriate use of rapid testing protocols to support compendial assays.
Progress:
Note: Projected start dates are estimates only. Development of a standard depends on SDO timelines, which can vary.
Assembled a Working Group: SCB initiated monthly working group meetings following a feasibility call in June 2024 to coordinate the standard advancement effort. The working group continue to define needs and gaps for standards development for RCR in the context of available regulatory and pharmacopeial guidance.
GET ENGAGED:
SCB needs subject matter experts like you to join the working group — contact SCB for more information.