HIGHLY POTENT & ONCOLOGY PLATFORM

One Source for Highly Potent & Oncological Products

  • >> Multiple Manufacturing Locations across Europe & USA offering flexibility of supply.
  • >> Integrated Supply: APIs & Oral / Sterile Drug Products.
  • >> Full-service Offering & Project Management, including Packaging / Labeling, Serialization in globally approved facilities.
  • >> One Partner / One Contact.
  • >> Multi-purpose Facilities > Processes specifically designed to safely handle Highly Potent Products with Containment Solutions up to Category 4.

Platform Description

CordenPharma’s Highly Potent & Oncology Platform utilizes state-of-the-art high containment technology and processes to manufacture Highly Potent Active Pharmaceutical Ingredients (APIs) and Drug Products.

CordenPharma offers:

  • >> Advanced Chemical Synthesis (SafeBridge® certified facility)
  • >> Cytotoxic & Cytostatic APIs
  • >> Oral Dose (tablets & capsules)
  • >> Injectables (liquid and lyophilized)
  • >> Highly Potent Peptides
  • >> Linker-warheads for Drug Conjugates
  • >> Preparative Chromatography Expertise

CordenPharma provides expertise and reliability which is second to none in quality, delivery times and high Right-First-Time performance.




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

Platform Capabilities

  • >> API Development (QbD)
  • >> API Commercial Manufacturing
  • >> Formulation Development & Commercial Manufacturing
  • >> Drug Products
    • >> Coated & Uncoated Tablets
    • >> Hard Gelatine Capsules
    • >> Cytotoxic / Cytostatic Injectable (vials & ampules)
  • >> Primary & Secondary Packaging
    • >> Blister & Bottle Packaging
    • >> Serialization & 2D Data Matrix Coding
  • >> Regulatory & Supply Chain
    • >> Global Distribution
    • >> Regulatory Support

Integrated Supply

CordenPharma’s ability to develop and manufacture Highly Potent and Oncological APIs, Finished Dosage and Packaging in our network of facilities allows clients full access to integrated services. This results in a simplified supply chain, reduced risk and cost associated with technology transfers, and ultimately faster production and delivery timelines.