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CordenPharma Launches Oral Solid Dose GMP Manufacturing for Clinical Trial Development

Corden Connect Newsletter
29 Oct 24
Dr. Brittany L. Hayes, Director, Global Highly Potent & Oncology Platform

Because Oral Solid Dose (OSD) capabilities are in high demand, CordenPharma made the strategic decision to enhance our offering with an investment of €10 million into the design and installation of a new GMP Clinical Trial Development (CTD) facility located in CordenPharma Plankstadt (DE). The installment of the new CTD facility is a response to our customers’ demands and the recognition of gaps in scale and technologies. Joining three other CTD facilities, each focused on either R&D formulation development or small-scale GMP manufacturing, the new facility will bridge the scale gap between these smaller scales and the two large-scale production facilities to manufacture GMP batches up to 60 kg. 

The new CTD facility will be equipped with all of the key oral solid dosage manufacturing needs including blending, granulation (high shear, fluid bed, roller compaction), compression, and coating. Investments in high potency filling equipment (powders, granules, pellets, minitablets) into capsules, hot melt extrusion, and the ability to operate with organic solvents are also being added. The facility is designed with multi-product capability, allowing multiple projects to run in parallel. Work on the facility has been completed and technical batches of new projects are currently being run. Qualification by the German authorities will occur in early 2025.

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