For customers looking to accelerate their therapeutic gene editing program from discovery to clinical trials, our Engineering Run and full CGMP compliant guide RNA (gRNA) manufacturing and sequencing services offer a streamlined solution. Backed by comprehensive documentation, our services simplify regulatory filings, offering a straightforward path to clinical success.
REQUEST CONSULTLeverage advanced CRISPR technology to empower and streamline genomics research and therapeutic development. Our specialized CGMP gRNA manufacturing and sequencing services ensure regulatory compliance while supporting complex gene editing projects. We are committed to delivering the highest manufacturing standards, ensuring that our gRNA products can enhance efficiency of CRISPR genome editing projects across every stage of therapeutic development. Bring your genomic research to the forefront of personalized medicine innovation.
Start the conversation today to explore how our CGMP gRNA Manufacturing Services can accelerate your therapeutic gene editing program.
IDT and Aldevron partnered with the Children’s Hospital of Philadelphia (CHOP) to manufacture the world’s first mRNA-based personalized CRISPR therapy for an infant with urea cycle disorder (UCD). Delivered in just six months—three times faster than standard timelines for gene editing drug products.
IDT’s gRNAs produced at its Therapeutic Oligonucleotide Manufacturing Facility deliver the high-quality current Good Manufacturing Practices (CGMP) material required for successful completion of your preclinical studies and clinical trials. To further support regulatory compliance and accelerate IND/CTA filings, IDT offers gRNA sequencing services for customers manufacturing their CGMP gRNAs with us.
Engineering Run: Synthetic gRNA produced by the same manufacturing process as CGMP products but with limited Quality Assurance documentation.
CGMP: Synthetic gRNA manufactured under CGMP-compliant conditions and includes full Quality Assurance Documentation.
gRNA Sequencing Services
Sequence-level contaminants during gRNA manufacturing can potentially compromise therapeutic efficacy and delay regulatory approvals. IDT can help by integrating gRNA sequencing into your Engineering Run or CGMP manufacturing workflow. Our orthogonal identity assay provides full-length sequence verification to support regulatory filings and accelerate your therapeutic development timelines, without the added complexity of third-party vendors.
| Engineering run | CGMP | |
|---|---|---|
| Cleanroom | Certification not required | ISO 8 Clean Room – Certified |
| Changeover | In-place with cleaning validation | In-place with cleaning validation |
| Materials | QA release on raw materials | QA release on raw materials |
| Batch records | Draft based on customer’s specifications | Based on customer specification |
| Release testing | Qualified methods | Validated methods |
Through comprehensive quality control and analytical testing, we are committed to ensure that our therapeutic oligonucleotides consistently meet the regulatory requirements to accelerate your project and bring your discoveries to life.
| Category | Attribute | Method |
|---|---|---|
| Identity | Molecular weight | ESI-MS |
| Sequence identity | NGS-based gRNA sequencing | |
| Purity | Purity | Single-channel CE or LC-MS |
| Process related impurities | Elemental impurities Residual solvents |
USP <233> USP <467> |
| Safety | Endotoxin Bioburden |
USP <85> limulus amebocyte lysate (LAL) USP <61/62> |
| Yield | UV/Vis | Optical density at 260nm |
| General | Appearance | Visual inspection |
Figure 1. Functional performance of 100 nt Cas9 sgRNAs targeting HPRT1 when used in K562 CRISPR editing and in vitro DNA cleavage experiments. CRISPR editing outcomes were assessed via NGS using the rhAmpSeq™ CRISPR Analysis System following electroporation (Lonza) into K562 cells. Cas9-mediated DNA cleavage in vitro was assessed using the Fragment Analyzer system. (n = 3, error bars represent standard deviation. RUO controls were purified using either HPLC or standard desalt methods). This data is generated from pilot runs on equivalent Q7 equipment using representative Q7 manufacturing processes, methods, and tests.
Figure 2. High sensitivity of the gRNA sequencing assay for detecting single and cumulative base-level contaminants. Serial dilutions of wildtype sgRNA were spiked with known SNP variants to empirically assess detection limits. Results demonstrate 100% specificity across multiple dilution points, confirming robust performance for identifying single and cumulative contaminants in modified sgRNAs (n = 8–12 technical replicates per dilution).
Yes, IDT provides complete NGS-based sequencing of Engineering Run and CGMP oligos as an identity assay for customers manufacturing gRNAs with us. This service helps confirm sequence identity as a release specification to support regulatory filings.
