HIGHLY POTENT & ONCOLOGY Home >> APIs >> Highly Potent &... Highly Potent & Oncology With over 25 years of experience in the handling of Highly Potent Intermediates and Active Pharmaceutical Ingredients (APIs), CordenPharma utilises sophisticated technologies and the combined capabilities of multiple global cGMP facilities to produce Highly Potent pharmaceutical Drug Products and their APIs. CordenPharma is additionally experienced in the small-volume production of Highly Potent Peptide APIs (solid and liquid-phase) for commercial use, with containment safety systems and procedures suitable for the production of compounds with exposure limits as low as category 4 . OEL Range ≥100 μg/m3 <100 - 10 μg/m3 <10 - 1 μg/m3 <1 - 50 ng/m3 <50 ng/m3 HIGHLY POTENT & ONCOLOGY API MANUFACTURING >> Demonstrated ability to handle products down to 1ng/m3 exposure limit >> SafeBridge® Program for “Potent Compound Safety Certification” >> Manufacturing vessels with high flexibility in size (1-16,000 L), compatibility (Hastelloy, glass-lined, steel) and temperature (-110°C to +120°C) >> QbD approach to development >> Multiple filtration options (centrifuges, filter dryers, filter presses) and material compatibility (Hastelloy, stainless steel) >> Multiple drying options (agitated & static dryers) and powder handling (isolator technology) >> Complete focus on providing differentiated value to customers through our unique combination of technology and talent >> Reliable supply to all regulated markets HIGHLY POTENT & ONCOLOGY API MANUFACTURING CAPABILITIES >> 6 Independent suites (1 L to 1,200 L) for small to mid-scale manufacturing >> 500,000 L of Total Manufacturing Capacity >> Containment Principles: >> Engineering Controls >> Containment Culture >> Process Development >> Occupational Health Pre-planning >> Containment Execution Cycle PREPARATIVE HPLC CAPABILITY IN HIGHLY POTENT & ONCOLOGY FACILITIES Flexible capacity in manufacturing compounds up to Occupational Exposure Limits (OEL) of 1 ng/m³ (full cGMP pilot plant for process scale-up and development, LTSS batches, start-up batches, and full-scale cGMP manufacturing) CordenPharma’s ability to develop and manufacture APIs, finished dosage Drug Products and Packaging in our network of facilities allows clients full access to integrated services, resulting in a simplified supply chain, reduced risk and cost associated with technology transfers, and ultimately faster production and delivery timelines. INTEGRATED SUPPLY CordenPharma’s ability to develop and manufacture Active Pharmaceutical Ingredients (APIs), Finished Dosage and Packaging in our network of facilities allows clients full access to integrated services resulting in a simplified supply chain, reduced risk and cost associated with technology transfers, and ultimately faster production and delivery timelines. LEARN MORE RELATED FACILITIES & PLATFORMS Facilities >> CordenPharma Boulder (CO, US) >> CordenPharma Colorado (US) Technology Platforms Highly Potent & Oncology Injectables NEWS & PRESS EVENTS RESOURCE LIBRARY CAREERS ABOUT US CONTACT US TERMS AND CONDITIONS PRIVACY POLICY MEDIA CONTACT IMPRESSUM SITE MAP COVID-19 UPDATE Also of Interest: Peptides Company Sterile Injectables New GMP Peptide Expansion in Colorado ©2021 CordenPharma International Website created by Advanta Advertising, LLC The CordenPharma Website is set to allow the use of cookies. Cookies help us to give you the best experience on our website. By clicking Accept or continuing to use the site, you agree to use our cookies. If you decline we will not track your information but your browsing experience might be limited. For more information on our Privacy Policy click here. ACCEPTDECLINE