You wish to carry out an analysis of synthetic peptides present in your matrices or finished products
What is a synthetic peptide?
A synthetic peptide is a chain of amino acids (like proteins, but shorter) that is artificially made in a laboratory, usually by chemical synthesis rather than biological means.
FILAB offers you the analysis of synthetic peptides
Peptides are versatile molecules used in various sectors such as pharmaceuticals and cosmetics. Their specificity and effectiveness allow them to play a key role in the development of new treatments or the improvement of skin care. This diversity of applications underscores the considerable potential of peptides and the importance of continuing research in this field.
Our analysis services on synthetic peptides
Purity control
Search for impurities and contaminants
Regulatory support for your quality files (ICH, pharmacopoeias, ISO, etc.)
Characterization of active ingredients
Checking the molecular mass and expected sequence
Stability studies (thermal, oxidative, hydrolytic stress)
Evaluating your synthetic peptides for the US market
We support manufacturers developing synthetic peptides based on already approved rDNA peptides, such as glucagon, liraglutide, nesiritide, teriparatide, or teduglutide.
According to FDA guidance, these products can be submitted as ANDAs (Abbreviated Application) rather than NDAs (Full Application), thereby reducing time and cost to market.
ANDA/NDA: placing on the American market
Indeed, manufacturers often find themselves faced with a question: should their synthetic peptide-based drug be submitted as an ANDA or as an NDA?
Thanks to our expertise in peptide mapping, characterization, and sequencing, FILAB helps you:
- Ensure the equivalence of your synthetic peptide with the reference product
- Prepare a robust dossier that complies with FDA requirements
Why analyze your synthetic peptides?
Synthetic peptides are widely used in the pharmaceutical, cosmetic, and biotechnology sectors. Their efficacy and safety depend directly on their purity, sequence, and stability.
Reliable analysis helps ensure the quality of your products, meet regulatory requirements, and accelerate your R&D or industrial projects.
Why choose FILAB for synthetic peptide analysis
Recognized expertise in chemical and biochemical analysis.
Independent and impartial results.
Personalized support: from one-off analyses to the implementation of monitoring programs.
Responsiveness thanks to an integrated laboratory located on a single site.
FAQ
Because its purity, sequence, and stability determine its efficacy and safety. Analysis ensures that it meets expected specifications and complies with regulatory standards.
- Chemical purity
- Exact sequence (peptide identity)
- Molecular mass
- Impurity profile (truncations, unintentional modifications)
- Stability under stress (temperature, oxidation, hydrolysis)
- Concentration and dosage
Peptides intended for the pharmaceutical sector must meet ICH and pharmacopoeial (USP, Ph. Eur.) requirements.
In the cosmetics sector, they must comply with Regulation (EC) No. 1223/2009.
Traceability and analytical documentation are essential for marketing.
- A crude peptide still contains impurities related to synthesis.
- A purified peptide has undergone purification steps (often preparative HPLC) and achieved a higher level of purity (>95% depending on the application).
