Introduction
Custom Peptide Mapping is a cornerstone analytical strategy in drug development, offering tailored solutions to address the unique challenges of modern biopharmaceuticals. By leveraging modern technologies and scientific expertise, providers like ResolveMass Laboratories Inc. deliver highly specific, regulatory-compliant data essential for successful drug programs.
🔗 Learn more about our Peptide Characterization Service
🔗 Explore our Peptide Sequencing Service
What is Custom Peptide Mapping?
It involves the detailed analysis of a protein’s structure by breaking it down into peptides and identifying each fragment using high-resolution techniques like LC-MS/MS. Unlike standard methods, Custom Mapping is tailored to specific project needs—whether it’s focusing on post-translational modifications (PTMs), verifying biosimilarity, or detecting impurities.
Why It Matters:
- Confirming the primary structure and identity of therapeutic proteins
- Detects critical quality attributes (CQAs)
- Supporting regulatory submissions (IND, BLA, NDA) with robust, detailed data
- Verifies process consistency during manufacturing
🔗 Understand the science behind Peptide Characterization.
How Custom Peptide Mapping Supports Drug Development
Customizing peptide mapping for your drug candidate ensures precise data collection and speeds up the drug development pipeline.
Key Benefits of Custom Peptide Mapping:
- Early identification of product heterogeneity
- Detailed understanding of post-translational modifications
- Validation of structural integrity
- Risk reduction during clinical phases
- Regulatory readiness with comprehensive documentation
🔗 Discover how Peptide Sequencing Service complements mapping.
ResolveMass Laboratories Approach to Custom Peptide Mapping
When you choose ResolveMass Laboratories for your Custom Mapping, you gain access to:
- State of the art Mass Spectrometry (Orbitrap, QTOF)
- Tailored enzymatic digestion protocols
- High sequence coverage (>98%)
- PTM analysis including glycosylation, oxidation, deamidation
- Comprehensive reporting in regulatory-ready formats
Each Custom Mapping project is managed by experienced scientists who understand the nuances of your molecule and therapeutic class.
🔗 Learn more about our Peptide Characterization expertise.
Critical Factors Influencing Custom Peptide Mapping Strategies
1. Molecule Complexity
Monoclonal antibodies (mAbs), fusion proteins, and peptides have different mapping requirements.
2. Regulatory Requirements
Custom mapping must align with FDA, EMA, and ICH guidelines, especially for biosimilars and biologics.
3. Project Timeline
Tight deadlines require rapid method development and flexible resource allocation.
4. Budget Constraints
Custom solutions allow optimization without compromising data integrity or quality.
🔗 Explore our flexible project offerings here.
Real-World Case Study: Rapid Biosimilarity Verification
Client: European Biotech Company
Project Goal: Demonstrate biosimilarity of a biosimilar to a reference biologic
Challenge: Complete high-resolution peptide mapping in 21 days to meet regulatory filing deadline
Solution by ResolveMass:
- Customized tryptic digestion
- High-resolution LC-MS/MS analysis
- Detailed PTM profiling
Outcome:
- 99.7% sequence coverage
- PTMs matched within 1% variance compared to innovator molecule
- Regulatory dossier filed successfully within 25 days
Cost savings: 18% lower than competitors
Timeline savings: Delivered 4 days ahead of schedule
🔗 Contact us to discuss your custom project needs.
FAQs on Custom Peptide Mapping
1. What is Custom Peptide Mapping?
A project-specific analytical workflow using advanced LC-MS/MS to address goals like PTM analysis, glycan profiling, or biosimilarity assessment.
2. Why is Custom Peptide Mapping important in drug development?
It ensures molecular integrity, consistency, and regulatory compliance-minimizing risk and supporting approval
3. How long does Custom Peptide Mapping typically take?
Depending on complexity, a full Custom Peptide Mapping project usually takes 2–5 weeks.
4. How much does Custom Peptide Mapping cost?
Pricing varies based on molecule complexity but typically ranges from $5,000 to $12,000 per project.
🔗 Learn about our affordable solutions.
5. Can Custom Peptide Mapping detect post-translational modifications?
Yes, we specialize in identifying all major PTMs, critical for confirming biological activity and stability.
6. Is Custom Peptide Mapping required for biosimilars?
Absolutely. Regulatory agencies require robust structural comparisons, making Custom Mapping essential for biosimilar development.
7. What techniques are used in Custom Peptide Mapping?
Techniques include enzymatic digestion, high-resolution LC-MS/MS, and bioinformatic data interpretation.
8. Can ResolveMass customize digestion protocols?
Yes, digestion and analysis methods are tailored to the molecule’s structure and project goals
9. What type of reports will I receive?
Clients receive detailed mapping reports, annotated spectra, sequence coverage maps, and PTM profiles in submission-ready formats.
10. How do I start a Custom Peptide Mapping project with ResolveMass?
🔗 Contact our team today to discuss your project scope and receive a customized quotation.
Why Choose ResolveMass for Custom Peptide Mapping?
- Over a decade of peptide analysis experience
- Flexible ,Advanced workflows tailored to your molecule
- Regulatory filing experience supporting INDs, BLAs
- Fast turnaround without compromising quality
- Transparent pricing and dedicated project management
🔗 Reach out to ResolveMass Laboratories here for expert guidance.
Conclusion
Custom Peptide Mapping is a cornerstone of successful drug development, and selecting the right partner can significantly impact your program’s success. ResolveMass Laboratories Inc. offers unparalleled expertise, cutting-edge technology, and a commitment to customized solutions that align with your goals and regulatory requirements. Contact us today to learn how our solutions can accelerate your drug development journey.
🔗 Learn more about Peptide Characterization Service
🔗 Dive deeper into Peptide Sequencing Services
🔗 Contact us now
ResolveMass Laboratories Inc.: Experience, Expertise, and Trust You Can Count On
ResolveMass Laboratories Inc. is a leading name in nitrosamine testing across the United States and Canada. With over a decade of experience, our PhD-level scientists specialize in Mass Spectrometry and nitrosamine impurity chemistry. We offer complete in-house solutions, including risk assessment, confirmatory analysis, regulatory documentation, and expert consultation. As one of the few Canadian CROs, we also provide custom synthesis of rare nitrosamine impurities unavailable elsewhere. Our commitment to advanced technology and regulatory compliance ensures accurate results and trusted partnerships. Choose ResolveMass Laboratories for precise and transparent nitrosamine testing services.
Ready to Get Started?
📩 Contact our expert team
📞 Request a quote for method development
📅 Book a consultation with our scientists
🧪 Submit your sample for testing
References
- Millán-Martín, S., Jakes, C., Carillo, S., Buchanan, T., Guender, M., Kristensen, D. B., Sloth, T. M., Ørgaard, M., Cook, K., & Bones, J. (2020). Inter-laboratory study of an optimised peptide mapping workflow using automated trypsin digestion for monitoring monoclonal antibody product quality attributes. Analytical and Bioanalytical Chemistry, 412(25), 6833–6848. https://doi.org/10.1007/s00216-020-02809-z
