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CordenPharma will build a clinical trial development facility for manufacture of oral solid dosage drug products at its Plankstadt facility near Heidelberg, Germany.
CordenPharma, a contract development manufacturing organization, announced on Nov. 30. 2021 that it plans to invest €9.7 million (US$10.9 million) into the design and installment of a new clinical trial development (CTD) facility for manufacturing oral solid dosage drug products at its Plankstadt facility near Heidelberg, Germany.
CordenPharma Plankstadt is currently the company’s center of excellence for development and manufacturing of highly potent oral solid drug products for compounds that have an occupational exposure level of less than one µg/m3. The new CTD facility will address a gap in scale, as a complement to three other CTD facilities that include 1–5 kg good manufacturing practice (GMP), 5–20 kg GMP, and non-GMP capabilities. The new facility (CTD 4) will manufacture GMP batches up to 50 kg. CTD 4 will be equipped with blending, granulation (high shear, fluid bed, roller compaction), compression, and coating. High potency capsule-filling equipment for adding powders, pellets, and mini-tablets into capsules; hot melt extrusion; 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. The facility is expected to be completed in the third quarter of 2022.