CordenPharma Highly Potent & Oncology Platform

The Expert Source for Highly Potent & Oncological Products 

Platform Manager
Jason Bertola
Director, Global Highly Potent & Oncology Platform, 
CordenPharma International

Jason.Bertola@cordenpharma.com

 
  • Multiple manufacturing locations across Europe and USA offering flexibility of supply.
  • Multi-purpose facilities specifically designed to safely handle highly potent substances. Our containment culture guarantees protection of operators and the environment.
  • Containment solutions up to OEB 5.
  • Oral grade API and Oral / Sterile Drug Products.
  • CordenPharma is the leading service provider in the synthesis, development, formulation and packaging of Highly Potent & Oncology APIs and Drug Products for customers worldwide.  
  • Full-service offering and project management, including packaging/labeling in globally approved facilities.

Platform Description

CordenPharma’s Highly Potent Platform utilizes specialized high containment technology to manufacture Highly Potent APIs – in CordenPharma Colorado (USA) - and Drug Products (formulation & packaging) – in CordenPharma Plankstadt (DE) – from development to commercial supply.  

Global regulatory approvals warrant worldwide market access for your products: CordenPharma’s Big Pharma legacy provides state-of-the-art expertise and reliability which is second to none in quality, delivery times, and high Right-First-Time performance.

CordenPharma provides a full range of Oncological Drug Product supply solutions with oral dosage (tablets & capsules), sterile liquid, and lyofilisation capability from development to commercial scale at CordenPharma Plankstadt (DE) and CordenPharma Latina (IT). In addition, Oncological APIs are developed and manufactured in our SafeBridge® certified facility at CordenPharma Colorado (USA).

Platform Capabilities

Highly Potent
  • API Development
  • API Commercial Manufacturing (SafeBridge Category 4, OEL ≤1 ng/m3)
  • Formulation Development
  • Drug Products
    • Coated & Uncoated Tablets
    • Hard Gelatine Capsules
  • Primary & Secondary Packaging
    • Blister & Bottle Packaging
    • Serialisation & 2D Data Matrix Coding
Oncology
  • Development by QbD
  • Oral Dosage Drug Products (Tablets & Capsules)
  • Sterile Liquid & Lyofilisation (Vials & Ampules)
  • Oncological Oral APIs 

Facilities Included in Platform