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Your CRISPR Guide

CRISPR Solutions For Every Milestone

From research-grade products through GMP-grade manufacturing, Synthego provides robust offerings, quality systems, and regulatory expertise needed to help move your program forward. Our continuum of CRISPR solutions supports researchers and developers at every step of their journey.

CRISPR Solutions For Every Milestone

Every CRISPR program follows a unique path, but each stage brings new scientific, manufacturing, and regulatory requirements. Whether you're optimizing guide RNAs in the lab or preparing materials for clinical studies, choosing the right manufacturing solution at the right time can reduce risk and simplify development. Explore how Synthego supports every milestone along the journey.

From discovery to GMP, Synthego scales.

See the Continuum in Action

Discover how successful CRISPR programs transition from discovery research through process development and clinical manufacturing. Learn practical strategies for scaling workflows while maintaining quality, reproducibility, and regulatory readiness.
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Manufacturing Solutions for Every Stage

Seamless transition from research to clinic without switching suppliers or compromising on quality.
Category RUO INDe® GMP
Typical Quantity Small Scale:
1.5 – 400 nmol

Mid Scale:
500 – 6,000 nmol

Large Scale:
100 mg – 10 g *
30 mg – 10 g * 30 mg – 10 g+ *
Manufacturing
Platform
Small Scale &
Mid Scale:

Scale-adapted unit operations

Large Scale:
Same unit operations as INDe and GMP
Same unit operations as Large Scale and GMP Same unit operations as Large Scale and INDe
Manufacturing Environment
Open research environments
Synthesis & Purification:
  • Controlled non-certified (CNC)
  • Temperature control and monitoring


  • Final Processing:
  • ISO 5 Biosafety Cabinet (BSC) with in-process environmental monitoring (EM)
  • ISO 7 certified clean room with temperature control and monitoring
  • Synthesis & Purification:
  • ISO 8 certified clean room with temperature control and monitoring and monthly EM


  • Final Processing:

  • ISO 5 Biosafety Cabinet (BSC) with in-process environmental monitoring (EM)
  • ISO 7 certified clean room with temperature control and monitoring
  • Documentation Small Scale &
    Mid Scale:

    QC Report
    (ESI-MS identification by Mass)

    Analytical HPLC Report included with HPLC purification

    Large Scale:
    Certificate of Testing (appearance, concentration, purity by HPLC-UV and ESI-MS identification by mass)
    Executed Batch Records

    Certificate of Analysis
    (with comprehensive tests including NGS sequencing, residual process impurities and microbiological QC tests such as endotoxin, bioburden, or sterility)

    Batch Disposition Form
    Executed Batch Records

    Certificate of Analysis
    (with comprehensive tests including NGS sequencing, residual process impurities and microbiological QC tests such as endotoxin, bioburden, or sterility)

    Certificate of Conformance with TSE/BSE statement

    Batch Disposition Form
    Project Management
    N/A
    Dedicated Alliance Manager with biweekly updates Dedicated Alliance Manager with biweekly updates
    Ordering Small Scale &
    Mid Scale:

    Web Ordering Available

    Large Scale:
    Contact Sales


    Contact Sales


    Contact Sales

    *Batch sizes include material required for QC and QA testing, stability retains, and product release. Final batch size depends on guide length, chemistry, purity, and manufacturing requirements. Contacts Sales to discuss your program. 

    Discovery & Research

    Supporting high-throughput screening, target validation, and proof-of-concept studies

    Every successful program begins with reliable, high-quality reagents. During discovery and early development, your focus is on identifying targets, optimizing experimental conditions, validating biological activity, and generating the data needed to advance. Speed, flexibility, and reproducibility are critical at this stage, making research-grade synthetic guide RNAs and CRISPR nucleases an ideal choice for rapid iteration and experimental optimization. As programs evolve, manufacturing needs often expand alongside experimental scope. From exploratory research to larger preclinical studies, access to scalable manufacturing enables teams to generate consistent data while maintaining continuity throughout development. By providing multiple manufacturing scales built on the same synthetic chemistry and quality standards, Synthego helps organizations grow their programs without unnecessary complexity.

    IND-enabling Development

    Generate the data and documentation required for regulatory readiness

    As CRISPR programs progress toward Investigational New Drug (IND) submission, expectations around documentation, traceability, and manufacturing controls increase significantly. Materials used during GLP toxicology studies and regulatory submissions must be produced under well-defined quality systems while providing the documentation necessary to support regulatory review. Synthego's INDe portfolio is designed specifically for this critical transition. By combining quality controls with enhanced documentation and manufacturing consistency, INDe materials help bridge the gap between research and GMP production. This enables your team to perform pivotal preclinical studies with confidence while reducing the risk of unexpected manufacturing changes later in development. Working with a single partner throughout development also minimizes technology transfer, simplifies supply chain management, and helps preserve continuity as programs advance toward the clinic.

    GMP Manufacturing

    Supporting clinical and commercial programs with confidence

    As programs advance, manufacturing priorities shift from development to long-term consistency, regulatory compliance, and reliable supply. GMP manufacturing requires robust quality systems, validated processes, comprehensive documentation, and a trusted partner capable of supporting evolving program needs. Synthego's GMP manufacturing portfolio delivers high-quality synthetic guide RNAs produced under rigorous quality management systems with extensive testing and documentation. Whether supporting clinical studies, commercial manufacturing, or long-term supply strategies, our team works alongside you to provide manufacturing continuity, regulatory support, and scalable production throughout the product lifecycle.

    Your Partner for GMP Success

    From initial planning through GMP manufacturing and documentation, Synthego partners with your team to help simplify the path to clinical and commercial success. Learn what to expect when starting your GMP project.
    Start your GMP Journey
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    More Than a Supplier. A True Development Partner.

    Expert support to help you de-risk, scale, and succeed.

    When it comes to advancing CRISPR-based therapies, Synthego is not just a supplier for an integrated continuum of CRISPR solutions, we are a committed partner with a proven track record in driving innovation and success. By choosing Synthego, you gain access to a comprehensive ecosystem of solutions, technical expertise, and collaborative support, all designed to accelerate your path from early discovery to clinical application. Our partnership approach is rooted in collaboration and transparency. From the outset, Synthego offers hands-on guidance in optimizing your project’s success. Whether it’s selecting the right products, navigating complex regulatory landscapes, or troubleshooting specific challenges, you’ll benefit from our world-class team.

    Let us be your Guide

    We're here to find the right solution for your stage of development. 

    Schedule a call today