Critical Reagents Customization
AES provides advanced icIEF analysis services to assess charge heterogeneity in therapeutic protein drugs, ensuring full compliance with FDA and ICH guidelines—including ICH Q6B—and supporting your development, release, and stability testing with precision and reliability.
| Quality Attribute (CQA) | Attribute Details | Analytical Service | Contract Service |
|---|---|---|---|
| Charge heterogeneity | Isoform pattern (acidic, basic, main species) | icIEF for routine profiling and lot-to-lot consistency | icIEF analytical |
| Identity | Unique pI profile of samples | icIEF for routine profiling and lot-to-lot consistency | icIEF analytical |
| Primary sequence | Amino acid sequence coverage and Molecular Weight | LC-MS for intact mass and peptide mapping | LCMS; Peptide mapping |
| Secondary structures | Disulfide linkages | Peptide mapping | LCMS; Peptide mapping |
| Product heterogeneity | PTMs related to charge heterogeneity and N-/ C-terminal modifications (Deamidation, oxidation, succinimidation, glycosylation et.al) | Auto-Prep icIEF for fractionation of charge variants, followed by further analysis such as icIEF-MS and peptide mapping | icIEF-MS online icIEF fractionation Peptide mapping |
| Product related substances, and impurities identification | Charge variants as product-related substances or impurities | Auto-Prep icIEF for fractionation of charge variants, followed by further analysis such as icIEF-MS and peptide mapping | icIEF-MS online icIEF fractionation Peptide mapping |
| Stability/degradation Products | Charge shifts due to degradation | Auto-Prep icIEF for fractionation of charge variants, followed by further analysis such as icIEF-MS and peptide mapping | icIEF-MS online Peptide mapping |
| Fractionation for potency analysis | Correlation of charge variants with biological activity | Auto-Prep icIEF for fractionation of charge variants | icIEF fractionation |
Why AES?
- Innovative Technology: CEInfinite systems enable high-resolution profiling and MS integration.
- Customized Expertise: Tailored analysis of CQAs.
- Proven Experience: Our scientists bring decades of biopharma knowledge to every project.
- Rapid Delivery: Comprehensive, regulatory-ready reports in weeks.
Key Services
- Charge Variants Profiling: Charge heterogeneity and identity confirmation via icIEF.
- PTM Analysis: PTM and impurity analysis with icIEF-MS and peptide mapping.
- Fractionation for Potency Evaluation: Potency evaluation through advanced fractionation.
Our Process
- Consult: Define your analytical needs with our team.
- Submit: Provide samples with detailed specifications.
- Analyze: Receive expert analysis powered by CEInfinite technology.
- Report: Obtain actionable reports for regulatory or internal use.
AES is the ONLY vendor globally who offers custom ampholyte solutions for icIEF of fusion proteins.
Traditional synthesis and production of carrier ampholytes lack precise control for icIEF applications, especially for complex biologics, such as ADCs, bispecific antibodies, fusion protein, AAV, and lipid nanoparticles, etc. Lot-to-lot consistency for icIEF of fusion proteins is not commercially available from any other ampholyte maker.
AES is the leader in the carrier ampholyte synthesis industry, our advanced techniques for consistency control enables custom development and custom manufacturing.
We provide technical solutions for carrier ampholyte development, including:
- Custom high-resolution ampholytes for challenging molecules
- Custom ampholyte synthesis to meet criteria of existing icIEF QC method
- Custom ampholyte characterization, and creation of recipe and specifications to support reagent lifecycle management for robust, reproducible assay performance
Exclusive Lot-to-Lot Consistency Guaranteed
Project Service
Fractionation
- Based on pressure mobilization technology to get accurate fractions and do not need to injection again.
- Achieve as high as 90% purity, high resolution (pI > 0.1) with great reproducibility automatic fractionation.
- Get as high as 8 µg isomer per run to support the further peptide mapping.
icIEF-MS
- Original and mature high-sensitivity ESI interface for icIEF Orbitrap directly detection.
- Native and denative MS mode.
- Reduce potential degradation during offline processes to increase the efficiency and effectiveness.
icIEF Analytical
- Customized supports methods for seamless methods transfer across platforms for existing projects.
- Method development for difficult projects, such as ADCs, fusion proteins, and providing a complete turnkey solution.
- High reproducibility ensured by high lot-to-lot consistency carrier ampholytes and pI markers.
Service Summary
| Part # | Item | Delivery Time | Sample Requirements | Standard Delivery Results |
|---|---|---|---|---|
| 300000 | Service – Critical Reagent | Depending on customer request | Depending on customer request | Depending on customer request |
| 300001 | Service – Analytical | 1-2 weeks | >500 μL; >1 mg/mL | For mAb, Bispecific, Trispecific, ADC, Enzyme, AAV, Fusion proteins and other complex molecules. Report: UV Spectra; Reproducibility of pls and peak areas. |
| 300002 | Service – Fractionation | 4-8 weeks | Depending on customer request | Get three groups (Acidic, Main, Basic) 50 μg for each group; >60% purity. Fractions collections resend to customer. Report: including UV spectra and reinjection purity spectra. |
| 300003 | Service – icIEF-MS | 2-6 weeks | >500 μL; >10 mg/mL | Report: UV Spectra; MS TIC spectra; corresponding deconvolution result. |
| 300004 | Service – Peptide Mapping | >8 weeks | >500 μL; >10 mg/mL | Report: UV Spectra; MS TIC spectra; corresponding deconvolution result; MS mapping results. |
Custom Reagents for Precise icIEF Analysis
Get the only carrier ampholytes designed for lot-to-lot consistency and complex biologics like ADCs, bispecific antibodies, and fusion proteins.
Still have questions? Let’s discuss your custom formulation needs!
