Prometic Bioseparations Increases Manufacturing Capacity for GMP- Standard Chromatography Adsorbents

For over 25 years, Prometic Bioseparations Ltd (PBL) has produced chromatography adsorbents in batch sizes up to 280 L under cleanroom/good manufacturing practice (GMP) conditions at its Isle of Man (UK) manufacturing site. Following a sustained increase in demand for its chromatography products, PBL made the decision to expand its manufacturing operations to meet the projected future demand. During 2013, designs to expand the plant were developed. Between 2014 and 2017, a major investment focused on the expansion of PBL’s Isle of Man manufacturing site to provide a significant increase in production scale. Maximum batch sizes have increased from 280 L to 1,000 L, and manufacturing capacity has increased to approaching 50,000 L per year. This makes Prometic one of the largest manufacturers of affinity adsorbents in the world.

At the heart of the new production capacity are 2 × 2,500-L reactors and associated buffer tanks and plant equipment, which enable GMP manufacture of individual adsorbent batches up to 1,000 L in volume. The reactors incorporate extensive automation and control systems to enable automatic operation. Such systems require significant instrumentation and sensor inputs and numerous automated valves. To manufacture adsorbent batches at this scale and to enable the automation of adsorbent washing steps, large volumes of wash buffers are required. Two 15,000-L stainless-steel buffer tanks were installed in an external tank farm and connected to the production areas by a newly constructed pipe bridge.

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