Factory 99% Purity Ss-31 Elamipretide CAS 736992-21-5 Door-To-Door Service

             Wuhan Newtop Biotech Co., Ltd is a professional chemical raw materials and peptides manufacturer with many years experince,Our factory has multiple production lines, supplying bottled Lyophilized Powder with purity exceeding 99%, and also supplying various raw powders with purity above 99%. Specializes in exporting high quality Pharmaceutical intermediates,Pharmaceutical raw materials,Safe Organic Solvents, Plant Extract, Spice Auxiliary and Hormones.We have our own delivery line to Canada,USA,UK,Spain,Netherland,Germany,Russia,Kazakhstan,Ukraine,etc. Door to door without any customs clearance issues.Our products are produced on the basis of best technical team, advanced equipment, high qualified management which meet the requirements of security and environmental protection.

Upstream peptide synthesis

        Wuhan Newtop Biotech Co., Ltd production plants are endowed with state-of-the-art equipment for solvent supply, peptide synthesis, purification and isolation of active ingredients and intermediates.

All equipment and containment is GMP qualified and cleaning validated. Overlapping capacities and sizes of different equipment trains facilitate a smooth scale-up for increases in demand within the product life cycle.

Downstream purification and isolation of peptides
      Wuhan Newtop Biotech Co., Ltd is committed to the systematic expansion and modernization of its purification equipment in order to ensure the efficient production of ever-increasing amounts of bulk peptide pharmaceuticals.

           It uses sophisticated methods for large scale purification campaigns such as preparative high performance liquid chromatography (HPLC), ion exchange (IEX), size-exclusion chromatography (SEC), and ultra-filtration (UF/TFF).

          The equipment in place permits highly efficient or even continuous manufacturing of extremely pure products up to multi-kg quantities per lot.

         For preparative HPLC, dynamic axial compression (DAC) stainless steel columns of up to 60 cm diameter both in batch and continuous mode are packed with the appropriate high performance silica separation phase. For low-pressure chromatography columns up to 80 cm diameter are available. Solvent delivery is ensured from eluent tank farms and containers.The control of microbiological contamination is a prerequisite for API manufacturing. Class D (ISO 8) and C (ISO 7) clean rooms are supplied via HEPA-filtered, temperature and humidity controlled air, down-flow booths are used for minimizing microbial contamination and protecting operators. Highly active pharmaceutical ingredients are handled in integrated safety workbenches or flexible isolators reaching OEB level 4 (1-10 µg/m3).Predefined physicochemical properties of the API can only be achieved by a carefully controlled isolation process. Besides precipitation and crystallization, lyophilization of intermediates and final API is a standard unit operation.   

          Wuhan Newtop Biotech Co., Ltd acquired early mastery of development and manufacturing of peptides, the short chain amino acids linked by peptide bonds that have enabled new generations of small molecule drugs that closely mimic the body's natural pathways.Wuhan Newtop Biotech Co., Ltd possesses first-class capabilities to manufacture peptides at industrial scale and in full compliance with the strictest Good Manufacturing Practice (GMP) standards.