For customers looking to accelerate their therapeutic gene editing program from discovery to clinical trials, our Engineering run and CGMP compliant gRNA (gRNA) Manufacturing Services offer a streamlined and regulated 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 approaches to genome research. Ensure regulatory compliance through our specialized CGMP gRNA Manufacturing Services, designed to support gene editing projects. This commitment to the highest standards ensures gRNA products enhance efficiency of CRISPR genome editing projects through the therapeutic development approval process. 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.
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-certified conditions and includes full Quality Assurance Documentation.
| Engineering run | CGMP | |
|---|---|---|
| Availability | Delivery times after placing the order | Delivery times after placing the order |
| 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 |
| 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.
IDT offers manufacturing support for every developmental stage to meet your needs including large scale guide RNAs produced under RUO conditions, Engineering run guide RNAs that are produced by the same manufacturing process as cGMP but with limited documentation and QC, as well as cGMP guide RNAs manufactured in an ICH Q7 compliant facility.
CGMP refers to products manufactured under ICHQ7; IDT engineering runs and CGMP gRNA are for development and investigational use only. The performance characteristics of this product have not been established. This product is not intended to be used as final drug product. The purchaser is solely responsible for all decisions regarding the intended use of the product and any associated legal or regulatory obligations.
