A substantial investment plan for new facilities and technologies has transformed our Company into a key player in the CDMO field, sought after for its qualified knowledge and expertise, for its capabilities and high tech solutions. Manufacturing operations are held in 4 GMP facilities, which feature semi-automated equipment with multi-scale capacity, housed in clean rooms and including cryogenic capabilities. An independent unit is devoted to High Potent API manufacturing.
Scale-up & industrialization
GMP manufacturing of APIs and related intermediates
• 1.000 m2 overall production areas, multi-scale capacity 25 L up to 6,000 L stainless-steel and glass-lined reactors
• 100 m3 reaction volume
• Hydrogenation reactor (500 L capacity, 10 Bar)
• Hastelloy reactor fully equipped for cryogenic reactions
• Finishing department equipped with paddle- dryers, biconical dryiers, conical millers and jet- mill for particle size reduction and control
• High-Potent Unit equipped with 2 isolators for handling and manufacturing of cytotoxic compounds
Icrom’s Clinical Scale API Plant has been engineered ensuring the perfect combination between technological excellence and flexibility to achieve the best efficiency in Customer’s CMC needs.
Leveraging sophisticated technologies and equipment, as well as accomplishing the strictest quality features, this brand new unit will operate, under GMP conditions, in scale-up, tech-transfer and manufacturing of specialty APIs including New Chemical Entities for clinical trials:
• 3 Hastelloy reactors (100 L, 200L, 400L)
• 3 stainless-steel reactors (100L, 200L, 400L)
• Hastelloy filter drier
• Dedicated centrifuge
• Dedicated static drier
• Industrial Chromatography system
Icrom’s Clinical Scale API Plant is equipped with industrial Chromatography system capable to enhance the industrial manufacturing of difficult to purify compounds, including small molecules and complex lipids in GMP conditions.
• Complete skid-mounted system designed for kilogram scale separations.
• Fast flow rates and permitted use of higher viscosity solvents.
• Radial compression technology ensuring minimization of wall effects and channelling inside each column leading to higher overall product’s yield.
• Interchangeable Cartridges for different applications
• Suitable for purification from multi-grams up to kg quantities of product.
• Capability of optimization of scale up parameters.