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GMP-COMPLIANT OLIGONUCLEOTIDE MANUFACTURING

Oligonucleotide Drug Acceleration Engine

CDMO Solution for Therapeutic Oligonucleotides: From Chemistry Synthesis to QC Release, addressing production bottlenecks to significantly shorten the regulatory timeline and accelerate your time-to-market.

SOLUTION

PLATFORM

RNA TYPES

TECHNOLOGY

WHY CHOOSE US

HOW TO START

One-Stop CRDMO Solution

From Target to IND

Discovery & Validation

Design & Synthesis

In Vitro Study

Lead Optimization

In Vivo Study

Toxicology

GMP Manufacturing

PCC

CMC & IND Support

Discovery and Validation

Select a biological target (e.g., mRNA, non-coding RNA, or protein) implicated in a disease using genomics, proteomics, or literature mining. Confirm the target's role in the disease using techniques like CRISPR, RNAi, or antisense knockdown in cellular or animal models. Validate relevance through biomarkers or phenotypic changes.

Oligonucleotide Design & Synthesis

Sequence Design: Use bioinformatics tools to design sequences with high specificity and minimal off-target effects. Consider secondary structures of target RNA.

Chemical Modifications: Incorporate modifications (e.g., phosphorothioate backbone, 2′-O-methyl, locked nucleic acids) to enhance stability, binding affinity, and reduce immunogenicity.

Synthesis: Produce candidates via solid-phase synthesis and purify using HPLC or other methods.

In Vitro Study

Efficacy Screening: Assess target engagement (e.g., mRNA knockdown via qPCR, protein reduction via Western blot) in disease-relevant cell lines.

Toxicity & Off-Target Effects: Evaluate cytotoxicity (cell viability assays) and off-target impacts using RNA-seq or microarrays.

Delivery Optimization: Test delivery systems (e.g., lipid nanoparticles, GalNAc conjugates) to improve cellular uptake.

Lead Optimization

Structure-Activity Relationship (SAR): Iteratively refine oligonucleotide chemistry and sequence based on in vitro data.

Delivery System Refinement: Optimize formulations for tissue targeting and biodistribution (e.g., liver-targeted GalNAc conjugation).

In Vivo Study

Pharmacokinetics (PK): Study absorption, distribution, metabolism, and excretion in animal models (rodents/non-rodents).

Pharmacodynamics (PD): Measure target modulation (e.g., mRNA/protein levels) and therapeutic effects in disease models.

Biodistribution: Use radiolabeling or fluorescence to track tissue uptake, particularly in target organs.

Toxicology & Safety Evaluation

Acute/Chronic Toxicity: Determine NOAEL (No-Observed-Adverse-Effect Level) and MTD (Maximum Tolerated Dose) in animal models.

Immunogenicity: Assess innate immune activation (e.g., cytokine release, complement activation).

Organ-Specific Toxicity: Evaluate effects on liver, kidney, and other organs via histopathology and serum biomarkers.

Scale-Up & GMP Manufacturing

Process Development: Transition to GMP-compliant synthesis for large-scale production.

Analytical Characterization: Ensure purity, stability, and quality using LC-MS, NMR, and other methods.

Formulation Development: Optimize drug product (e.g., lyophilized powder, liquid solution) for storage and delivery.

Preclinical Candidate Completion (PCC)

Candidate Selection: Finalize the lead oligonucleotide based on optimized efficacy, safety, and manufacturability.

Milestone Review: Confirm readiness for clinical trials through internal/governance review, ensuring all PCC criteria (e.g., target engagement, safety margins) are met.

CMC Development & IND-Enabling Support

Optimize synthesis/purification processes for scale-up (GMP compliance).

Develop stable formulations (e.g., lyophilized powders) and QC assays (HPLC, LC-MS).

Prepare and submit IND packages (nonclinical/CMC data, clinical protocols), with regulatory strategy alignment via pre-IND FDA/EMA consultations.

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RNA TYPES

Comprehensive RNA TYPES, Tailored Expertise for Your Needs

At Integraterna, we specialize in research and services for various RNA types, helping you delve into the cutting edge of molecular biology to drive advancements in both research and clinical fields. With an advanced technology platform, an experienced team, and comprehensive services, we are committed to helping you achieve breakthroughs in RNA research.

TECHNOLOGY

Pioneering Technologies, Deeper Insights

Circular RNA In Vitro Synthesis

CircRNAs represent a new generation of therapeutic mRNAs with advantages including enhanced stability, lower immunogenicity, and specific translation targeting. They can produce more therapeutic protein than conventional mRNA, potentially engineering cells, replacing damaged proteins, or adding beneficial proteins for patients with serious diseases.

IntegrateRNA has developed and optimized circular RNA in vitro synthesis platforms, establishing both T4 DNA/RNA ligase and CBITR circularization systems for research and pharmaceutical-grade customized circular RNA products. Submit your target RNA sequence for free consultation and evaluation.

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Self-amplifying RNA In Vitro Synthesis

Self-amplifying RNAs (saRNAs) are a specialized mRNA subclass capable of self-replication by leveraging cellular machinery. This unique feature makes saRNA vaccines highly advantageous, enabling exponential antigen expression for enhanced immune response. Compared to conventional mRNA vaccines, saRNA achieves comparable protection with lower doses while supporting prolonged antigen expression in vivo.

IntegrateRNA offers custom saRNA synthesis from milligram to multigram scales. With a robust and flexible saRNA platform, our services encompass codon optimization, saRNA design, template preparation, in vitro transcription, purification, and rigorous quality control.

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tRNA In Vitro Synthesis

Transfer RNAs (tRNAs) are key molecules that carry amino acids to ribosomes and decode the genetic code using anticodons to translate genetic information into the primary sequence of a polypeptide chain. In vitro synthetic tRNAs have provided new ways to study protein structure, dynamics, post-translational modifications, and cell-free protein synthesis, as well as manufacture protein-drug conjugates.

IntegrateRNA offers in vitro synthetic tRNA charged with natural amino acid or non-canonical amino acid (ncAA), including fluorescent-labeled amino acid, biotin-labeled amino acid, and functional amino acid.

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GalNAc-Oligonucleotide Conjugation

GalNAc (N-Acetylgalactosamine) binds selectively to the asialoglycoprotein receptor (ASGPR) on hepatocytes, enabling targeted liver delivery of oligonucleotides. This approach has revolutionized nucleic acid therapeutics, enhancing efficacy and specificity in liver-directed treatments.

IntegrateRNA provides custom GalNAc-conjugated oligonucleotides with monovalent or trivalent GalNAc clusters at the 3′- or 5′-end. Our conjugates are compatible with DNA, 2'-OMe, 2'-MOE, and 2'-F oligonucleotides, with phosphodiester or phosphorothioate linkage options for optimized stability and performance.

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Lipid Nanoparticles Formulation and Development

Lipid nanoparticles (LNPs) are considered to be state-of-the-art technology for nucleic acid delivery. LNPs are capable of encapsulating and delivering therapeutic agents to specific locations in the body and releasing their contents at the desired time, thus providing a valuable platform for the treatment of a variety of diseases.

In order to facilitate the development of RNA therapeutics and the application of related research, IntegrateRNA is committed to developing safer and more effective RNA delivery systems for our customers around the world to improve RNA stability and enhance the ability of cells to take up and release RNA.

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High-Throughput LNP Formulation Screening

High-throughput LNP screening identifies the most effective and stable formulations for nucleic acid delivery, optimizing efficiency while minimizing toxicity. This process evaluates a diverse library of LNPs, varying in lipid composition, size, charge, and surface modifications.

IntegrateRNA supports early-stage LNP development by screening engineered formulations to ensure efficient cellular uptake, intracellular release, and cargo stability for optimal drug delivery.

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WHY CHOOSE US

Tailored Solutions, Dedicated Team

Industry Expertise

With data from 3,000+ projects across 20+ fields, IntegrateRNA offers proactive solutions, addressing RNA degradation early to minimize delays.

Cost Management

Strategic partnerships and optimized workflows reduce reagent costs and synthesis time, keeping costs 10% below industry standards without compromising quality.

Responsive Service

24-hour cross-timezone support reduces delivery times by 20%, with real-time updates through dedicated accounts.

Scale Transition

Seamless lab-to-commercial manufacturing ensures consistent quality at any scale.

Quality Assurance

GMP-compliant standards and rigorous controls ensure safe, effective mRNA products.

15+ Years of Nucleic Acid Innovation with IntegraterRNA—Where Industrial Partnerships Catalyze Scientific Advancements into Commercial Triumphs.

Seamless Project Execution in 6 Steps

Inquiry

Expert Assessment

Proposal

Quotation

Project Startup

Project Delivery

Submit Inquiry Form

Step 1

Complete ourproject consultation form with your objectives, experimental details, andtechnical requirements.

Receive Expert Feedback

Step 2

Our specialistteam will contact you within 24-48 hours with preliminary recommendations andmay request additional information.

Project Discussion

Step 3

Collaborate withour experts to refine project specifications, timeline, and budget to ensurealignment with your needs.

Finalize Agreement

Step 4

Upon mutualagreement, sign contract and confirm service details to officially initiate theproject.

Track Progress

Step 5

Monitor projectadvancement through regular status updates and provide feedback throughout theexecution phase.

Review Results

Step 6

Receivecomprehensive analytical reports upon completion, with follow-up support toensure maximum value from your results.