A proposal to align release standards for endonucleases used in nucleic acid removal

Endonucleases are enzymes which cleave a polynucleotide chain by separating nucleotides. Although they are used ubiquitously in cell and gene therapy (CGT), there is a lack of defined release test criteria throughout the pharmacopeial landscape, particularly for those enzymes used in the nucleic acid removal steps of manufacturing. This bioprocessing step is predominated by commercially available Serratia marcescens-derived endonucleases recombinantly expressed from different host cell systems, marketed and sold in similar formulations under various brands.

Pharmaceutical compendial standards provide guidance and criteria via monographs and general chapters, and are the framework for many ancillary raw material control strategies. This paper proposes to unify the polychotomy of current industry approaches with a single core standard of test methods and criteria necessary for GMP manufacturing. A common testing standard would have multiple benefits including consistency across suppliers, protection of supplier intellectual property (IP), and facilitation of drug development.

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  • Create Date 10th May 2023
  • DOI https://doi.org/10.46220/2023CGT002
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