BRIEFING

 〈1067〉 Best Practices for the Manufacture and Quality Control of Recombinant Adeno-Associated Virus Gene Therapy Products. The Biologics Monographs 5 Advanced Therapies Expert Committee is proposing the following new general chapter. The purpose of this chapter is to describe best practices for the structure, manufacture, and quality control of recombinant adeno-associated virus (rAAV) products that are intended for in vivo gene delivery applications. This chapter provides a general overview of the rAAV construct design, along with the control strategy for their manufacture and quality control at small- or large-scale production. The rAAV products covered in this chapter may be produced either as a drug substance or a drug product for both nonclinical and clinical applications.

 (BIO5: R. Potts)

 Case ID—SUB-1980