Our Cgmp Peptide for Your Innovation, Where Chemistry Meets
Standard Express PeptideTM cGMP Custom Peptide Custom Recombinant Peptide Synthesis Synthesis Peptide Synthesis Library Services Peptide Services
OurOur cGMPcGMP PeptidePeptide forfor youryour Innovation,Innovation, wherewhere ChemistryChemistry meetsmeets Biology.Biology.
GenScript manufactures high quality cGMP peptides delivering ever demanding services to our clients with the goal to meet stringent requirements and cast its fine print in the industry. Our confidence originated from our advanced technological capabilities. We assure our robust, economical FlexPeptideTM technology will optimize peptide manufacturing processes in all details.
GenScript cGMP Peptide Service Features:
Complete confidentiality
Extensive experiences in cGMP peptide synthesis
Full support for your FDA submissions
cGMP-complying quality management system
Ensured delivery time
Priced for any budget
Long-term stability for security of supply
GenScript The Biology CRO
120 Centennial Ave., Piscataway, NJ 08854, USA Toll-Free: 1-877-436-7274 (1-877-GenScript) Tel: 1-732-885-9188 Fax: 1-732-210-0262 Email: [email protected] Web: www.genscript.com Standard Express PeptideTM cGMP Custom Peptide Custom Recombinant Peptide Synthesis Synthesis Peptide Synthesis Library Services Peptide Services
Synthesis Strategy: Solid phase, solution phase, and combination Current capacity: up to 50 L (solid), 500 L (solution) reaction volume Batch size: up to kilograms level of API per batch
Purification and Lyophilization Preparative HPLC systems Conventional chromatographic methods (TLC, RPHPLC) Gram to hundred-gram level of lyophilizer
Quality Control Equipment validation Stability tests Batch traceability of all raw materials GenScriptGenScript isis thethe PartnerPartner Certificates of analysis for all raw materials Batch records for each step in the manufacturing process ofof youryour Growth!Growth!
Quality Assurance and Regulations Strict Compliance with cGMP and FDA guidelines Comprehensive documentations and complete confidentiality Standard cGMP COA (Certificate of Analysis) include: • Appearance • Trifluoroacetic Acid • Solubility • Counterion Content • Identity (by MS, AAA, and HPLC) • Water • Peptide Purity (by HPLC) • Mass Balance • Related Substances (by HPLC) • Specific Rotation • Assay (by Peptide Content) • Residual Organic Solvents • Bacterial Endotoxins • Bioburden • Inorganic Flouride (if appropriate)
If you have any additional specifications, we are pleased to add them to our COA list.
Pilot cGMP Plant We have the experience in cGMP peptide synthesis in phase I-III of clinical trials for the development of peptide drugs.
Generic APIs
Abarelix ACTH Accolate Alarelin Atosiban Bivalirudin Buserelin
Calcitonin Carbetocin Cetrorelix Deslorelin Eledoisin Eptifibatide Ganirelix
Desmopressin GHRP-2 Glucagon Gonadorelin Goserelin Leuprorelin Lypressin
Nafarelin Nesiritide Octreotide Oxytocin Pitressin Pramlintide pTH
Somatostatin Terlipressin Thymopentin Thymosin α1 Triptorelin Vapreotide Sincalide
Your Innovative Partner in Drug Discovery!