Custom Bulk ASO Synthesis
Clinical-Grade Manufacturing from Multi-Nanomole to Multi-Gram Scale
Comprehensive ASO Manufacturing Capabilities
From Research Validation to Clinical Development
AUM Biotech provides therapeutic-grade antisense oligonucleotides with comprehensive chemical modification capabilities for preclinical and clinical development. Our scalable GMP-compliant manufacturing platform delivers consistent quality from research-scale (µmol) through commercial production (multi-gram) with validated analytical methods and complete regulatory documentation.
Whether you're advancing a target from research validation to preclinical studies, or require therapeutic-grade ASO drug substance for clinical trials, our custom synthesis service delivers the exact modifications, scale, and purity you need.
Comprehensive Modification Capabilities
Access any combination of sugar and backbone modifications to optimize your therapeutic ASO
Sugar Modifications
- 2'-O-Methyl (2'-OMe) - Enhanced nuclease resistance
- 2'-O-Methoxyethyl (2'-MOE) - Superior pharmacokinetics
- 2'-Fluoro (2'-F) - Increased binding affinity
- Locked Nucleic Acid - Maximum target affinity
Backbone Modifications
- Phosphorothioate (PS) - Nuclease resistance & protein binding
- Phosphodiester (PO) - Natural backbone structure
- Mixed PS/PO - Optimized stability/activity balance
- Custom Chimeric Designs - Tailored for your application
Flexible Scale Options
Seamless scaling from research to clinical production
| Scale Tier | Quantity Range | Typical Applications | Turnaround |
|---|---|---|---|
| Research Scale | 1-10 µmol | Target validation, initial screening, mechanism studies | 2-3 weeks |
| Pre-Clinical | 10-100 µmol | In vivo efficacy, PK/PD studies, dose-response optimization | 3-4 weeks |
| Clinical Pilot | 100-1000 µmol | IND-enabling toxicology, Phase I trial material, formulation development | 6-8 weeks |
| Bulk Production | 1 - 500+ grams | Phase I/II/III clinical trials, drug substance manufacturing, commercial supply | 8-24 weeks |
Clinical-Grade Purification & QC
Multiple purification tiers to meet your quality requirements
Purification Methods
- Cartridge Purification - Standard desalting
- RP-HPLC - High purity (>95%)
- IE-HPLC - Ultra-high purity (>98%, >99%)
- GMP-Compliant HPLC - Clinical-grade production
Quality Assurance
- MALDI-TOF MS - Molecular weight confirmation
- HPLC Analysis - Purity verification
- Endotoxin Testing - For in vivo applications
- Certificate of Analysis - Complete analytical package
- GMP Documentation - Optional for clinical use
Delivery & Storage
Ensuring stability from manufacturing to your lab
Shipping Format
- Lyophilized Powder - Maximum stability for long-term storage
- Solution Format - Ready-to-use for immediate applications
- Cold Chain Shipping - Temperature-controlled delivery
- Custom Aliquoting - Minimize freeze-thaw cycles
Storage Recommendations
- Lyophilized - Store at -20°C, stable for 24+ months
- Solution (sterile) - Store at -80°C, aliquot to avoid freeze-thaw
- Reconstitution - Nuclease-free water or PBS recommended
- Stability Data - Available upon request for clinical batches
Overcoming Common ASO Development Challenges
Expert solutions for difficult synthesis and scale-up problems
Challenging Sequences
Successfully synthesize difficult sequences including G-rich regions, poly-purine stretches, and highly repetitive motifs that cause failures at other manufacturers
High-Concentration Formulations
Achieve formulation concentrations up to 200 mg/mL with minimal aggregation through optimized buffer systems and excipient selection
Seamless Scale-Up
Prevent scale-dependent failures through early process optimization and robust analytical methods that transfer smoothly from development to production
Complex Modification Patterns
Custom gapmer designs, mixed backbone chemistries, and position-specific modifications tailored to optimize your ASO's activity and safety profile
Immunostimulation Mitigation
Minimize innate immune activation through strategic sequence design and chemical modification patterns that reduce TLR7/8/9 engagement while maintaining target potency
Analytical Method Development
Custom analytical method development and validation for complex modification patterns, ensuring CMC-compliant characterization from research through IND submission
Why Choose AUM Biotech for Custom Synthesis
Comprehensive Modification Expertise
Complete synthesis capabilities for therapeutic ASO chemistries including 2'-O-Methoxyethyl (MOE), 2'-O-Methyl (OMe), 2'-Fluoro modifications with phosphorothioate, phosphodiester, or custom mixed backbone configurations
Scalable GMP Manufacturing
Seamless scaling from development (1 µmol) to commercial production (500+ grams) with validated processes ensuring batch-to-batch reproducibility and consistent purity profiles
Rapid Turnaround
Competitive turnaround times through in-house expertise and streamlined workflows
Partnership Approach
Partner with our PhD scientists throughout your ASO program - from sequence design and chemistry optimization to CMC documentation and regulatory filing support
Quality Assurance
Comprehensive analytical testing including MALDI-TOF MS, HPLC purity analysis, endotoxin testing, and complete Certificate of Analysis with optional GMP documentation for IND/CTA submissions
Scientific Support
Direct access to experienced oligonucleotide chemists for sequence design consultation, modification strategy, analytical method development, and troubleshooting throughout your project lifecycle
Request Custom Quote
Provide your ASO specifications and we'll respond within 24 hours
Accelerate Your ASO Development Program
Our oligonucleotide chemistry experts are ready to discuss your therapeutic program, optimize your ASO design for potency and safety, and provide guidance on scale-up strategy, purification methods, and regulatory requirements. Schedule a consultation to accelerate your path to the clinic.
Already submitted a quote? Our team will respond within one business day with detailed pricing and lead time information.