Accelerate Your cGMP gRNA Manufacturing from Sequence to Clinic

Aldevron has joined forces with Integrated DNA Technologies (IDT), both part of the Danaher family, to bring oligonucleotide manufacturing and cGMP gene-editing therapeutic expertise together under one roof. Under Danaher, we combine IDT’s expertise and innovation in oligonucleotide synthesis with our cGMP manufacturing experience to offer streamlined access to advanced technologies, faster timelines, and dedicated support. This simplifies the journey from discovery to clinical application, advancing progress in gene-editing therapeutics.

Overview

Your therapeutic gene editing program requires precision, speed, and scalability. Aldevron’s cGMP gRNA manufacturing services are engineered to support preclinical studies and clinical trials, delivering consistent performance with robust analytical controls and efficient regulatory documentation to advance your gene-editing therapeutics.

Real-World Impact: Pioneering personalized CRISPR therapy

Aldevron and IDT 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).

We delivered this life-saving therapy in just six months—three times faster than standard timelines for gene editing drug products.

Read the full story here

Manufacturing Overview

Service Details

Aldevron’s synthetic gRNAs are manufactured in our state-of-the-art, 41,000-square-foot Therapeutic Oligonucleotide Manufacturing Facility. To further support regulatory compliance and accelerate Investigational New Drug (IND) and Clinical Trial Application (CTA) filings, we also offer guide RNA sequencing services for our cGMP clients.

Synthetic cGMP gRNAs are manufactured to comply with ICH Q7. This service includes comprehensive quality documentation, ensuring your material is ready for clinical applications. Engineering Run gRNA is also available for early-phase testing.

gRNA Sequencing Services

Sequence-level contaminants during gRNA manufacturing can potentially compromise therapeutic efficacy and delay regulatory approvals. Aldevron can help by incorporating gRNA sequencing into release testing. This 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.

Comparison of Service Levels

Rigorous Quality Control and Sequencing

To ensure the safety and efficacy of your therapeutic, we apply stringent quality control measures. We also offer next-generation sequencing (NGS) services to verify gRNA identity and detect sequence-level contaminants.

Partner With Us to Advance Your Genome Editing Therapeutics

Streamline your logistics and enhance your gene editing processes with our proven manufacturing capabilities. Let us handle the complexities of production and compliance so you can focus on developing life-changing therapies.