Introduction: Why Characterization of Peptides for FDA Matters
The characterization of peptides for FDA approval is a very important part in the development and regulatory approval of synthetic peptides. Pharmaceutical innovators and generic companies must make sure that their lab made peptide drug products are structurally and functionally similar to the Reference Listed Drug (RLD). At ResolveMass Laboratories Inc., we focus on NMR-based structural analysis, giving strong and clear NMR structure elucidation services made for FDA-rules. Our skills cover important peptide medacines such as Semaglutide, Liraglutide, Lanreotide, and Ganirelix.
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Importance of Peptide Characterization in FDA Submission
FDA Requirements for Peptide Characterization
In FDA’s eyes, establishing comparability to the RLD involves detailed molecule – level study. This includes:
- Primary structure validation
- Disulfide bridge mapping
- Higher-order structural conformation
- Impurity profiling
- Functional equivalence
Given the complicated nature of peptides, especially those with many disulfide bonds and complex folding patterns, NMR spectroscopy for drug discovery becomes very important.
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👉 Learn MoreSemaglutide and Liraglutide: GLP-1 Analogs with Complex Architecture
Both Semaglutide and Liraglutide are long-acting GLP-1 receptor agonists. Because of fatty acid side-chain changes and multiple structural differences, their NMR-based structural analysis needs multi step NMR techniques.
At ResolveMass:
- We check where fatty acids are attached using HSQC and TOCSY
- Validate N-terminal changes and acetylations
- Quantify how close the structure is to RLDs using RMSD (root mean square deviation) scores
Why pharma uses NMR spectroscopy: Unlike other methods, NMR gives detailed 3D proof of peptide fold in natural-like conditions.
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Lanreotide and Ganirelix: Cyclic and Antagonist Peptides
Lanreotide, a somatostatin analog, and Ganirelix, a GnRH antagonist, represent two different types of lab made peptides. Lanreotide’s cyclic structure and disulfide bond need careful mapping, while Ganirelix’s linear antagonist profile requires functional testing with bioassay comparison.
Our approach includes:
- Disulfide bridge determination using 2D NOESY
- HPLC and LC-MS for sequence confirmation
- Comparative NMR overlay with RLD structures
Outsourcing NMR structure elucidation services to ResolveMass gives you trust in regulatory submission.
Case Study: Semaglutide ANDA Submission
Client: North American generic manufacturer
Objective: Show that generic Semaglutide is structurally similar to Ozempic® (RLD)
Methodology:
- 1H and 13C NMR Spectra (Bruker Avance III HD 600 MHz)
- 2D COSY, HSQC, NOESY spectra
- RP-HPLC fingerprinting
- Mass spectrometry impurity profiling
Outcome:
- 98.6% structural similarity by NMR overlay
- FDA accepted submission within 11 months
- Zero data deficiency letters received
This real example shows our strong experience and skill in FDA-level peptide testing.
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Regulatory Alignment: ICH Q6B and FDA Draft Guidelines
All testing packages follow:
- ICH Q6B rules for Biotech Products
- FDA Peptide Guidlines (2021)
- EMA guidelines for product comparison
ResolveMass gives full paperwork, including:
- Raw NMR results
- Method validation reports
- Certificate of structural match
Why Choose ResolveMass Laboratories Inc.
With over 10 years of strong experience in peptide analytics:
- ISO-certified facility
- Follows GMP
- Proprietary peptide structure elucidation software
Trust is earned through consistent results. Our clients return for:
- Batch-to-batch comparability
- Fast service (full report in under 4 weeks)
- Regulatory support from early research to FDA filing
Start with our peptide NMR lab
Frequently Asked Questions (FAQs)
1. What is peptide characterization and why is it important for FDA?
Characterization of peptides for FDA means checking the chemical structure, purity, and biological activity of a lab made peptide to make sure it is the same to the original drug (RLD). It’s a very important step in both NDA and ANDA filings.
2. How does NMR help in peptide structure analysis?
NMR structure study helps us to see the 3D shape of peptides in solution, shows how the peptide folds, disulfide bonds, and chemical changes that other tools might miss.
3. Why is structural comparison to RLD so crucial?
If you can’t prove your drug is the same as the original one, Reference Listed Drug (RLD), the FDA won’t allow it. NMR-based structure checking helps make that comparison clear and reliable.
4. What makes NMR spectroscopy superior to X-ray or CD for peptides?
NMR spectroscopy for drug discovery can study peptides in liquid without needing to turn them into crystals, this shows how the drug really behave in real life conditions.
5. Can NMR detect impurities in synthetic peptides?
Yes, even small unwanted parts or damage are easily visible as separate peaks in 1D or 2D NMR tests. We also use LC-MS and HPLC to double-check the results.
6. How long does peptide characterization take?
ResolveMass usually gives a full report in 3–4 weeks, including NMR, mass spectroscopy, and other comparison tests.
7. Do you help with FDA submissions too?
Yes, we do. We give you all the test reports and expert help you need to apply for NDA, ANDA, or 505(b)(2) with the FDA.
8. How is Lanreotide different from Semaglutide in testing?
Lanreotide is cyclic and has many disulfide bonds, while Semaglutide is linear and has fatty acid parts. Each one needs a different NMR test plan.
9. Can I send only NMR parts to ResolveMass and conduct other tests in-house?
Yes. Many clients only send us NMR structure elucidation services and do other tests like bioassays and MS in their own labs. We’re happy to offer flexible options.
10. How can I get a price or start working with ResolveMass?
Visit our contact page or submit a peptide inquiry form. Our team will usually get back to you within 24 hours.
Real-Time Case Study: Semaglutide Reverse Engineering
Background: A generic pharmaceutical company approached ResolveMass to develop a generic version of Semaglutide for submission to the FDA.
Approach:
- Chiral analysis revealed stereochemical uniformity with the RLD.
- High-resolution MS/MS was used to confirm the 31-amino acid sequence with accuracy.
- Impurities such as oxidized methionine and deamidation were quantified (<0.2%).
- The entire process matched over 98.7% similarity to the RLD profile.
Outcome:
- Our characterization report was directly submitted in the Type II DMF and contributed to successful ANDA approval.
More on this: Peptide Sequencing of Semaglutide
Cost-Effective FDA-Compliant Peptide Analysis
Characterization of peptides for FDA can be cost-intensive without proper planning. ResolveMass offers transparent pricing models that reduce uncertainty for early-stage and generic drug developers.
Check pricing: Cost of Peptide Analysis
Conclusion
The study of peptide structure for FDA approval is not just a rule to follow—it’s a must for good science. Whether you’re working on Semaglutide, Liraglutide, Lanreotide, or Ganirelix, showing that the structure is the same as the original approved drug (RLD) is a must. ResolveMass Laboratories Inc. offers extremely accurate NMR-based structure testing, trusted by top drug makers. From figuring out the peptide structure using NMR to handling the full NMR testing for you, we connect science with rules—clearly, quickly, and dependably.
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