Scaling up Production
Astrea Bioseparations has been manufacturing high quality chromatography adsorbents on the Isle of Man since 1989. In a previous article we highlighted our intention to become the first GMP qualified chromatography adsorbent manufacturer. In this article we will update you on the expansion of our adsorbent manufacturing capacity.
Over the last 3 years there has been major investment in Astrea Bioseparations' Isle of Man manufacturing facilities to provide a significant increase in production scale from a maximum batch size of 280 L to 1,000 L and an increase annual manufacturing capacity to over 35,000 L. This makes Astrea Bioseparations one of the largest manufacturers of affinity adsorbents in the world.
Astrea Bioseparations has been producing chromatography adsorbents, under cleanroom/GMP conditions, at a scale of up to 280 L batch volume, for over 25 years. A sustained increase in customer demand for Astrea Bioseparations' chromatography products meant the existing capacity would not meet future requirements so in the latter half of 2013, plans to expand the plant were developed.
Work began on the new production space in June 2014 which was constructed within the existing building foot-print in an area previously used as a warehouse (which was relocated to a new building). At the heart of the new production capacity are 2 x 2,500 litre reactors and associated buffer tanks and plant equipment which enable the manufacture of individual adsorbent batches up to 1,000 litre in volume to be produced under GMP conditions.
The first stage of the project was the removal of existing floors and internal walls and installation of foundations and drainage for the new rooms. During this initial phase a number of utilities and services had to be relocated and/or upgraded which included an overall power upgrade for the building and doubling of purified water production and storage capacity.
Once the internal floors and walls were constructed, HVAC, sanitary wall coverings and a chemically resistant resin floor finish were installed to create ISO Class 8 clean rooms. All of Astrea Bioseparations' chromatography adsorbents are manufactured in controlled environment clean-rooms which conform to ISO Class 8 standard or better.
Final positioning of the reactors and mixing tanks was undertaken using an A frame and hoist. Once in their final positions the installation of process pipework, control systems and plant services could commence.
Process pipework was constructed from high-grade stainless steel tubing and installed by highly skilled welders.
The reactors incorporate extensive automation and control systems to enable automatic operation of adsorbent manufacture. Such systems require significant instrumentation & sensor inputs and numerous automated valves.
To enable automation of adsorbent washing steps large volumes of wash buffers are required. Two 15,000 litre buffer tanks were installed in the external tank farm and connected to the production areas by a newly constructed pipe bridge.
To facilitate rapid heating and cooling of vessels a bespoke heating/cooling system was designed and installed. This system incorporates large capacity heating and cooling units capable of increasing or reducing the temperature of fully charged reactors and mixing tanks by 50˚C in approximately 2 hours.
On completion of plant construction in 2016, the significant task of plant Installation and Operational qualification (IQ/OQ) commenced. This work was completed October 2017 at which time the new plant was taken over by Astrea Bioseparations and process qualification work (PQ) commenced.
From early 2018 Astrea Bioseparations will commence routine manufacturing operations in this facility and be able to produce chromatography adsorbents with batch sizes of up to 1,000L manufactured to GMP standard in clean-room facilities certified to ISO8. This makes Astrea Bioseparations one of the highest quality, largest volume affinity adsorbent manufacturers in the world.