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CRISPR RNP-Based Genome Editing

with cGMP Capacity

Aldevron now offers a full RNP service solution* to streamline your CRISPR reagents into therapies. Working with your unique guide RNAs (gRNAs), we’ve defined the optimal conditions for complexing, characterizing, and storing CRISPR RNPs created with Aldevron research and GMP-grade CRISPR/Cas9 proteins.

RNP-complex

Aldevron provides two conceivable solutions for your CRISPR-associated gene editing program using RNPs. Maximizing our expertise in protein manufacturing, we have combined this with a comprehensive RNP production service to provide your optimal final gene editing drug substance. This is done by utilizing either our readily available GMP-grade nucleases or manufacturing a custom nuclease to your specific needs to produce the desired RNP complex.

With our abundant offering, Aldevron provides the highest quality and control for the scalable manufacturing of the nuclease and the combined RNP complex. We are dedicated to deliver reliability and lot-to-lot consistency for your RNP gene editing project by meeting industry standards and following Regulatory guidance. Therefore, we aid in all stages of your workflow to complete IND submission through commercialization.

*Aldevron provides RNPs only to customers who are duly licensed, including to make and have made RNPs, for their intended use.

Learn more in our article about CRISPR RNPs and the Future of Cell and Gene Therapy

Regulatory Support

To be delivered as a therapeutic, the composition of the CRISPR RNP needs to be highly defined. Aldevron uses a variety of in-house methods to quantify the amount of complexed RNP, relative to uncomplexed, free-Cas9 and free-gRNA, during cGMP manufacturing. In addition, our proprietary release panels are compliant with 21CFR210-211 and designed to meet current draft guidance from the FDA regarding gene editing, which provides consistency of the final product.

RNP QC test panel

Product Characteristics Concentration
Activity (in vitro)*
Appearance
Residual free intact gRNA (Purity)*
Residual free Cas9 (Purity)*
pH
Osmolality
Critical Contaminants Residual DNase
Endotoxin
Bioburden or Sterility
Mycoplasma

Aldevron Advantage

During RNP development, Aldevron will

This section will contain Resource (constantly updated when new content is generated).

Contact Aldevron to learn more about how you can accelerate your RNP program to IND filing.