Protein sequencing testing : what are we talking about ?
Confirming the primary structure is the most fundamental requirement for any biopharmaceutical product. While DNA sequencing provides the theoretical blueprint, only direct protein sequencing can verify what was actually produced, confirming the absence of mutations, truncations, or unexpected Post-Translational Modifications (PTMs).
Regulatory guidelines, including ICH Q6B, mandate the experimental verification of the amino acid sequence for new biologics and biosimilars.
FILAB supports biopharmaceutical companies with comprehensive sequencing services. We combine the historical gold standard (Edman Degradation) with cutting-edge Mass Spectrometry (De Novo Sequencing) to provide 100% sequence coverage reliability.
Our sequencing methodologies
Protein Sequencing
The most powerful method for full-length sequencing and identification of unknown proteins.
- Full Sequence Coverage: we use multiple enzymatic digestions (Trypsin, Chymotrypsin, Glu-C, Asp-N) to create overlapping peptides, ensuring every single amino acid is sequenced.
- Unknown Identification: perfect for identifying impurities, Host Cell Proteins (HCPs), or reverse-engineering competitor products without prior knowledge of the DNA sequence.
Still required by regulators to confirm the integrity of the protein's start.
- N-Terminal Verification: we determine the first 5 to 15 amino acids from the N-terminus to confirm identity and check for signal peptide cleavage issues.
- Blockage Analysis: investigation of N-terminal blocking (e.g., pyroglutamate formation) that prevents sequencing.
- Sequence Confirmation
- PTM Localization.
Why choose FILAB ?
- Regulatory compliance: Services fully compliant with ICH Q6B guidelines and ISO 17025 accreditation for regulatory submissions.
- Dual competence: Chemistry / Materials
- Problem solving: we don't just deliver spectra; we provide a complete interpretation of your drug candidate's structure
Our FAQ
Yes. This is called De Novo sequencing. By using multiple enzymes and high-resolution MS/MS, we can reconstruct the full sequence of the Heavy and Light chains, including the variable hypervariable regions (CDRs), without needing the DNA sequence.
For Mass Spectrometry, modern instruments are very sensitive; 50-100 µg is often sufficient for full coverage. For Edman degradation, we typically require 50-100 pmol of protein.
To get a quote, you can contact our team via our contact form, by phone, or by email.
Simply send us your requirements (material type, desired analysis, specific standards, urgency, number of samples, etc.). We will then send you a personalized technical and price proposal within 24 to 48 hours.
Turnaround times vary depending on the nature of the analysis and the complexity of the project.
However, FILAB is committed to providing fast results tailored to your industrial constraints and urgent needs.
