HIGHLY POTENT & ONCOLOGY
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.
