30 November 2021 – Luxembourg > CordenPharma, a full-service Contract Development Manufacturing Organization (CDMO) of Active Pharmaceutical Ingredients (APIs), Excipients, Drug Products & Packaging services, is pleased to announce the investment of €9.7 Million into the design and installment of a new GMP Clinical Trial Development (CTD) facility for the manufacturing of oral solid dosage Drug Products at our From early-stage development to full commercial scale, CordenPharma Plankstadt is our Centre of Excellence for the Development & Manufacturing of Highly Potent Oral Solid Drug Products for compounds that have an OEL level < 1 µg/m3. We specialize in the safe handling of Highly Potent APIs and Drug Products, offering a full range of services for pharmaceutical development including manufacturing, packaging, and pharma-logistics.
The installment of the new CTD facility at CordenPharma Plankstadt is a response to our customers’ demands and the recognition of gaps in scale, formulation development technologies for insoluble APIs, and manufacturing of capsule products. Joining three other CTD facilities (CTD 1: 1-5 kg GMP; CTD 2: 5-20 kg GMP; CTD 3: non-GMP), CTD 4 will bridge the scale gap between CTD 2 and the two Production Facilities (PF 1 and PF 2) to manufacture GMP batches up to 50 kg. CTD 4 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, pellets, mini-tablets) into capsules, hot melt extrusion (HME), and the ability to operate with organic solvents are also being added. The facility will be designed with multi-product capability, allowing multiple projects to run in parallel. Work has recently started in the fourth quarter of 2021, with a targeted completion date in the third quarter of 2022.
CordenPharma’s Highly Potent Oral Solid Drug Product Centre of Excellence in CordenPharma Plankstadt (DE).
“This is an extremely important and significant investment for CordenPharma Plankstadt. The new CTD 4 facility will bridge the gap between our small-scale GMP and larger commercial production facilities. It also expands our capabilities beyond coated tablets with the addition of contained-capsule filling equipment,” states Dr. Lutz Henkel, Managing Director of CordenPharma Plankstadt. “CordenPharma’s goal is to be the leading CDMO for the development and manufacturing of Highly Potent & Oncology solid dosage forms. Adding Hot Melt Extrusion to our toolbox allows us to help more customers that have solubility-limited APIs. We are excited about this investment in Plankstadt, as it strengthens our core capabilities and expands our service offerings,” adds Dr. Brittany Hayes, Director of CordenPharma’s Global The investment in CordenPharma Plankstadt is the latest of several announced investments made by CordenPharma during 2021, where further capacity expansion and capabilities have been installed in CordenPharma Colorado and CordenPharma Chenôve to meet growing customer demands.
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