CordenPharma, a full-service CDMO of Active APIs, excipients, drug products and packaging services, is investing €9.7 million to design and install a new GMP Clinical Trial Development (CTD) facility for the manufacture of oral solid dosage drug products at its Plankstadt facility near Heidelberg, Germany.
 
CordenPharma Plankstadt is the company’s Centre of Excellence for the Development and Manufacture of Highly Potent Oral Solid Drug Products for compounds that have an OEL level < 1 µg/m3, from early-stage development to full commercial scale. The company specializes in the safe handling of HPAPIs and drug products, offering services for pharmaceutical development including manufacturing, packaging, and logistics.
 
With the installment of the new CTD facility, CordenPharma is responding to customer demand 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, with a targeted completion date in 3Q22.
 
“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,” said, Dr. Brittany Hayes, Director of CordenPharma’s Global Highly Potent & Oncology Platform.