Bayer expands cGMP capacity in Spain

Bayer's new multi-purpose cGMP facility Novochem 2000 is scheduled to come on stream by the end of this year. Built in association with the company's Spanish partners Derivados Quimicos, the six-line plant has 28,000 gallon reactor capacity with glass-lined, stainless and hastelloy vessels ranging from 500 to 2,000 gallons. Five lines are designed for the isolation of solids and one for hydrogenations and distillations.

The reactors use a combination of quick connections and flexible lines to allow for reconfiguration between products, giving fast and highly variable capacity covering a range of volumes and chemistries.

Once the plant comes on stream, Bayer will be able to supply launch and commercial-scale quantities of advanced intermediates and APIs, said Dr Rudolf Hanko, head of the Fine Chemicals Business Unit. The facility is well suited for 1 – 10 ton campaigns, but also has the capacity to supply smaller scale quantities for Phase III clinical trials, as well as having the ability to manufacture products in quantities greater than 100 tons.

Bayer is also planning to build a GMP kilo-lab at its ZeTO pilot plant in Leverkusen to meet the need for manufacturing the 10 – 50kg quantities needed for Phase I and Phase II clinical trials.

According to Dr Hanko, this dual location approach is logical because some products are considerably more demanding than others. 'The ZeTO pilot plant offers tremendous process development and chemical engineering expertise to meet the toughest chemical challenges. In contrast, Novochem is optimised for mainstream chemistry and mature processes,' he explained. 'Both, however, offer the same commitment to quality, speed, reliability and service.'

The latest technology to be installed at ZeTO is a GMP-qualified pilot unit for continuous racemate separation. Using the SMB (simulated moving bed) principle, the process enables enantiomeric excesses of more than 98% to be achieved.