Sigma-Aldrich completes expansion of Scottish biopharmaceutical plant
US-based Sigma-Aldrich Corporation has recently completed the expansion of its European biopharmaceutical facility at Irvine in Scotland. The US$12m (€10.2m) spend has increased the floor area by 6,500m2, and includes bulk sterile media and reagent production facilities, QC labs and raw material and finished goods warehousing.
Other features of the expansion are segregation of animal and non animal-derived material, a 10,00 litre manufacturing vessel in a Class 10,000 clean room and a bespoke bulk container filling rig sited in a Class 100,000 cleanroom capable of sterile filling containers from 1-1,000 litres. The vessel and filling rig have a CIP/SIP system, there are dedicated purified water and water for injection systems and all facilities are validated to cGMP. Batch sizes up to 10,000 litres for bags and containers and 2,000l for bottles can be handled, as well as pack sizes from 5ml to 1,000 litres.
Sigma-Aldrich has experienced rapid growth in its European cell culture business to the biotech industry, with sales almost quadrupling in the last two years. The new production area will satisfy the trend towards dedicated space for the production of non-animal containing media and downstream processing buffers, the company said. The new facilities will also allow it to address the market trend towards greater liquid media supply versus powder usage and outsourcing of media preparation due to increased regulatory constraints.
The company has also recently completed an expansion of the kilolab facility and implemented new simulated moving bed (SMB) technology at its custom manufacturing plant in Buchs in Switzerland, which undertakes complex multi-step organic synthesis to produce active pharmaceutical ingredients and intermediates. The kilolab facilities now offer a scale-up lab for process development up to 20 litre scale and a GMP kilolab for the production of grams-to-kilograms quantities of APIs or intermediates under GMP up to clinical Phase II.
According to the company, important aspects of the design of the new facility include appropriate capacity; avoidance of cross-contamination; safe handling of large quantities of solvents; and protection of users against toxic and hazardous compounds. There are four fume hoods, each with an individual filtered air supply and separated via a cabin in front.
The SMB equipment is part of the new kilolab and offers powerful technology for the continuous separation of chiral compounds up to kilogram scale with high purity and recovery rates. The technology offers significant cost savings because it reduces solvent use by 90% due to recycling and cuts packing material use by 80% because high plate counts or particle sizes are not required.