HIGHLY POTENT & ONCOLOGY APIs

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 .



Criteria


Category 1


Category 2


Category 3A
Highly Potent

Category 3B


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.