colorado EXPERTS TAKING CARE
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1 CordenPharma colorado EXPERTS TAKING CARE
2 Our History : Arapahoe Chemicals founded with focus on fine organic chemicals : Acquired by Syntex Corporation with focus on Naprosyn and highly active compounds : Acquired by Roche with focus on peptides, highly active compounds and complex small molecules 2011: Acquired by ICIG to become CordenPharma Colorado with focus on peptides, highly active compounds and complex small molecules us
3 cordenpharma colorado Your CMO Partner > 40 Years of Experience CordenPharma Colorado, located in Boulder, CO, USA, is a world leader in the development and manufacturing of chemically synthesized peptide APIs. Starting as a technology-based contract manufacturing business in 1946, CordenPharma Colorado has contributed important technical advances to API manufacturing, most recently in the fields of highly active compounds and peptide synthesis. Our facility is registered globally for producing six APIs and several intermediates. In addition, we have supplied clinical trials in a large number of highly active, small molecule and peptide projects, and developed second generation processes for high volume small molecules. Our expertise in peptide and small molecule manufacturing has been realized through significant investments in advanced chemical process equipment and state-of-the-art environmental facilities and infrastructure. Compliance Worldwide FDA Compliant DEA Inspections * RCRA Inspections * , 2008, 2012 OSHA Inspection * EPA/CDPHE Air Inspections * Colorado Board of Pharmacy Inspection * * No Violations
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7 what we do Small to Large-Scale Peptide Production Highly Active APIs CordenPharma Colorado has the largest capacity for the synthesis and purification of peptides in the world. The Colorado site is the only company to have produced metric tons of the complex peptide Fuzeon (enfuvirtide). Various solid phase synthesizers from 12L to 10,000L are available for solid-phase synthesis. CordenPharma Colorado surpasses industry standards by providing the most extensive preparative HPLC equipment possible for peptide purification with column diameters ranging from 2cm to 100cm. As the volume leader in custom peptide production, we are committed to addressing complex solvent handling, recovery and recycling logistics. Furthermore, our large-scale peptide production toolset includes proprietary peptide precipitation know-how for cost effective final-step peptide isolation. CordenPharma Colorado is additionally experienced in the smallvolume production of complex small molecules and highly potent compounds, including highly active peptide APIs, for commercial use. Our SafeBridge certified containment safety systems and procedures are designed for the production of highly potent compounds with exposure limits down to 1ng/m 3. Core Capabilities Development and manufacturing of advanced intermediates and chemically synthesized APIs Focus on synthetic peptides, highly potent Cytotoxic and non-cytotoxic APIs SafeBridge certified production areas for highly potent compounds Large-scale peptide production Manufacture of high volume small molecule APIs Our expertise distinguishes us as a reliable commercial CMO partner supplying high-value APIs in a sustainable, compliant manner to all our customers.
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11 Technologies / Processes Hydrogenation / Hydrogenolysis Cryogenic chemistry Pyrophoric chemistry Chiral chemistry Pegylation chemistry Pre-formulated liquid products Peptides Peptide solid phase synthesis (10,000L) Cyclization (up to 18,000L) De-aggregation chemistry (Pseudoprolines, DMB) Low Pressure preparative chromatography (Ion exchange, size exclusion) Ultrafiltration, Diafiltration Precipitation of peptides ( allows larger batches) High Pressure preparative chromatography (up to 1M diameter) Lab equipment design (mimics plant design) Equipment Details Large-scale Pilot plant Peptide purification Highly active compounds Capacities One of the largest vessel capacities in the API Contract Manufacturing arena Nearly 470,000L vessel volume available Other Specialties Current APIs Enfuvirtide Valcyte Cymevene Linaclotide Rocaltrol Highly Active Peptide A Protease Inhibitor Intermediate
12 CordenPharma Colorado 2075 North 55th Street Boulder, Colorado USA Phone +1 (303) Fax +1 (303)
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