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Research and development
Consulting
General description of peptide products. Review of patent, scientific and technological literature. Literature and patent search. Testing and efficiency of a peptide substance. Preclinical and clinical studies, conditions and results. Selection and justification of the method to obtain a peptide. Preliminary calculation of the cost of customized peptide synthesis and contract production. Specific features of registration of medicinal products, dietary supplements, cosmetics.
Synthesis
Fine organic synthesis. Synthesis of peptides, intermediates, semifinished products. Classic synthesis of peptides in a solution. Solid-phase peptide synthesis. Laboratory synthesis and scaling of technology. From 1 mg to 100 kg. Production of cyclic peptides, disulfide bonds. Acylation, pegylation etc. Production of amides. Modification. Fluorescent labels. "Protected" peptides. With non-natural amino acid residues. Reagents for peptide synthesis. "Protected" amino acids: Ac, Z, Boc, Fmoc, OMe, OtBu, OBzl and others. Active amino acid esters: ONp, ONSu, OPfp and others.
Development
Selection and justification of the active peptide. Studies based on the required indications for use. Selection of raw materials and product development. Comparative characteristics and justification of biologically active ingredients. Stability and efficiency testing. Preparation of a composition, biologically active additive, cosmetic and medicinal product.
Technology
New development and improvement of an existing technology. Design of the laboratory and production premises. Chemical laboratory and manufacturing engineering. Preparation of laboratory and industrial regulations. Production process diagram. Description of the production process by stages. Material balance. Hardware support. Cost calculation.
Registration
Registration of a medicinal product, dietary supplement, cosmetic product in a state register. A complete package of documents. Preparation of technical specifications, standard operating procedures, registration dossier and other documents. Obtaining a registration certificate.
Assay
Preparation of an analytical report. Confirmation of the authenticity and purity of peptide products. Amino acid analysis. Chromatography. Spectrometry. Residual content of water and solvents. Quantitative analysis. Stability testing, accelerated aging. Analyses: HPLC, LCMS, NMR, GLC, IR, UV and others.
Manufacturing
Contract manufacturing of products at our site. Scaling of the production process.
Packaging
Obtaining solutions of peptides and lyophilizate. Obtaining peptide mixtures and compositions. Sterile packaging in a clean Class A zone. Packaging in pouches, vials, bottles and other containers.
