Building a better future with biologics

Published: 4-Mar-2016

UK government investment in the new National Biologics Manufacturing Centre is paving the way for a bigger future in biological treatments in the UK. Susan Birks looks at what went into the design and build of this new facility

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Built as a result of the UK government’s Strategy for UK Life Sciences, which was launched in 2011 to strengthen the life-science sector, the National Biologics Manufacturing Centre is a £38m investment to help UK companies to develop a competitive foothold in the growing biologics market. The Centre for Process Innovation (CPI) was selected to develop and manage this large, open access facility that will help companies of all sizes to develop, prove, prototype and scale up the next generation of biologic products, processes and technology.

Located at Central Park, Darlington, the Biologics Centre will support the commercialisation of research by promoting collaboration between academia, the National Health Service and industry. The facility provides a well serviced, flexible laboratory and pilot plant areas for process, analytical and technology development, cleanrooms for GMP process and equipment proving and flexible, open-plan areas where new facility design concepts can be developed and tested. In addition to the technical facilities, the centre will provide training and conferencing facilities, together with office and meeting spaces.

Biologics – the latest generation of medicines created using biological processes rather than chemical synthesis – are generated from living systems, usually cultured mammalian or microbial cells that have been selected based on their ability to produce the molecule of interest in economic quantities. The use of biologics as therapeutics has steadily increased over the past decade; currently some of the biggest-selling drugs are biologics, which are used to treat various forms of cancer, auto-immune diseases such as arthritis, and other diseases which are caused by a shortage of signalling proteins such as hormones and growth factors.

CPI can help organisations to adopt innovative new process and manufacturing technologies by demonstrating they are fit for purpose in a commercial setting and benchmarking performance against existing technologies on live process streams. The new Centre has the capabilities to work with the full spectrum of bio-molecules, including viruses and other novel derivatives of therapeutic proteins and antibodies.

Early determination of manufacturability is a key step in selecting clinical biological candidates. CPI uses advanced process, analytical and automation technologies to enable rapid development and optimisation of upstream and downstream processes across the spectrum of biologics, including the newer generation of products.

International support services and construction company Interserve Construction was awarded the design and build contract for the new facility, but many other suppliers also participated. Ardmac, for example, was involved in delivering cleanrooms following an extensive design phase, which included contemporary architectural design of exhibition spaces and live R&D environments by Archial Norr.

CPI has the facilities to assess innovative fill finish technologies on site in an industrially relevant environment. Developing and integrating new and improved analytical technologies for biologics underpins the development

CPI has the facilities to assess innovative fill finish technologies on site in an industrially relevant environment. Developing and integrating new and improved analytical technologies for biologics underpins the development

With all labs and cleanrooms requiring flexibility for a number of different processes, project delivery of this kind was not without its challenges, says Ardmac. The lack of roof space meant there was not sufficient head height to accommodate a walk-on ceiling, so M&E services had to be installed from below. Ardmac provided a flexible approach to its construction methodology to allow for walls to be installed initially, followed by the ceiling. This gave provision for the M&E first fix installation to overlap with the architectural fit out of the walling.

Ardmac Senior Engineer, Lee Harvey said: ‘Projects like this are always interesting for our team. They allow us to draw on our extensive knowledge of high GMP architectural practice and combine it with more contemporary layouts and architectural features that a modern building like this commands. As a Centre for Process Innovation, the cleanrooms need process flexibility, so it is very highly serviced.’

To deal with the various waste streams, Suncombe provided its EDS+ Effluent Decontamination System range, with additional features developed to suit the client’s specific requirements. Suncombe engineers were part of the team that constructed a 3-D model of the proposed build, which integrated with the site’s overall layout, to allow visualisation of the precise location and position of the treatment facility (see Figure 1).

Figure 1: Suncombe provided the effluent decontamination design information

Figure 1: Suncombe provided the effluent decontamination design information

Steve Overton, Technical Director at Suncombe, said: ‘The team we were a part of, particularly the CPI staff, made this a very rewarding and exciting project to work on. Everyone came together very quickly to deliver a highly complex facility on schedule and to specification.’

The project scope included the connection of user points (sinks) and a collection sump to the collection pipework, plus the design and modelling of this pipework, in stainless steel from the laboratories to the EDS+ system. It incorporated a number of technical advances, including different user-level log-in facilities, variable treatment temperatures and times, anti-foam control, pH neutralisation, out-of-hours cooling methodology and 100% positive release for treated waste. Another feature was emergency discharge to a road tanker.

Extensive pre-delivery tests were carried out to ensure that, on delivery to site, the system could be reconnected and ready for operation without any hitches. factory acceptance tests (FATs) included system documentation and certification reviews, as well as full testing, including automation and dry run simulations, wet testing and system thermal inactivation cycles.

The effluent decontamination system

The effluent decontamination system

HVAC services

The HVAC building services provided to the cleanrooms were designed, co-ordinated, installed and commissioned by SES Engineering Services. They included: process steam, process and instrument air, oxygen, nitrogen, carbon dioxide, 5% carbon dioxide, drainage, lab drainage, cold water services (CWS,) domestic hot water services (DHWS), a low temperature hot-water heating system (LTHW), chilled water systems (CHW), power and data.

The SES Engineering Services pre-fabricated solution for the cleanroom service risers enabled a high quality product to be integrated into the cleanrooms. The service risers included a multitude of the above detailed services which could be quality assured prior to delivery to the project.

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