CordenPharma is your full-service CDMO in the manufacturing of innovative APIs, Lipid Excipients and Drug Products. Through a network of facilities organized under five technology platforms - Peptides - Lipids & Carbohydrates - Injectables - Highly Potent & Oncology - Small Molecules - CordenPharma experts translate complex ideas into high-value products.

Peptides

• World-class development & manufacturing services seamlessly supporting all clinical & commercial stages
• Fully-integrated solution from drug substance to fill & finish drug product
• Unique expertise in both SPPS & LPPS technology for efficient Peptide manufacturing
• Full access to batch record process (you own the IP) and knowledge sharing guaranteed
• Largest equipment available to leverage sizeable up and downstream processes for your APIs
• Solvent recycling concepts with a green manufacturing approach

Lipids & Carbohydrates

• Specialized Lipids offering including custom & standard lipids (Glycero-Phospholipids, Sphingolipids, Phosphocholine, Pegylated, and Cationic Lipids)
• Lipids for support of mRNA vaccine production including Phosphocholine, Pegylated, Cationic Lipids and highly pure plant-based CP BotaniChol® (cholesterol)
• Fully-integrated service offering > from APIs to finished dosage and pharmaceutical services (clinical trial kits preparation, randomization and logistics)
• Backward integration of key starting materials to secure supply chain
• Manufacturing of carbohydrate-based APIs, vaccines, delivery systems, and conjugates (with lipids and/or peptides for receptor targeting)

Sterile Injectables

• Wide & balanced range of injectable services (including combining injectable drugs & devices as combination products)
• Aseptic & Terminal Sterilization Fill & Finish Technologies for Pre-Filled Syringes (PFS), ampoules, liquid and lyophilized vials, supporting a wide range of filling volumes
• Substantial Drug Product regulatory and filing experience globally (EMEA, FDA, PMDA)
• Packaging / labeling Clinical trial drug kit management (logistics, track & trace, documentation)
• LNP Formulation of Drug Products

Highly Potent & Oncology

• API Development & Commercial Manufacturing (SafeBridge Category 4, OEL =50 ng/m3)
  • High Containment for Cytotoxic & Cytostatic APIs
  • Low Volume (Clinical Batches > Commercial Manufacturing)
  • Quality by Design (QbD) Development Approach
  • Highly Potent Small Molecules & Peptides (Solid & Solution-Phase)
  • Highly Potent Purification by Chromatography

• Drug Product Development & Manufacturing

  • Oral Solid Dose
  • Highly Potent Drug Products
  • Full Development Capabilities (from 100g to commercial-scale)
  • Quality by Design (QbD) Development Approach
  • Coated & Uncoated Tablets
  • Hard Gelatine Capsules
  • Pediatric Formulations
  • Packaging: Blisters & Bottles
  • Serialization & 2D Data Matrix Coding

Small Molecules

• Integrated network of cGMP facilities across Europe and US
• 1,200 m3 of volumetric capacity in 20 L - 28,000 L reactors with various materials of construction
• Clinical (Phase I-III) and ongoing commercial supply to multiple markets around the world (including US, Europe and Japan)
• Kilo to Multi-ton production volumes per annum
• Process development capabilities (including flow / continuous manufacturing
• All sites FDA & EMEA approved facilities with successful regulatory & customer audits
• Strong EHS programs in place at sites