COMMENT A lot has been said about ESG in recent years, and rightly so, as companies strive to demonstrate their sustainability credentials and ethical values to consumers and investors. However, while we know a lot about the “E” and the “S”, the “G” does not often get the attention it deserves. Governance is of course important to all sectors, but none more so than life science as it continues its rapid growth here in the UK.
What is clear is that the life science sector is unique in terms of its ESG requirements. For example, from an environmental perspective, the challenges relate to energy use given the increased cooling loads required as a result of lab equipment and increased digitisation, while historically it has often been reliant on natural gas boilers. There are also environmental (and social) complexities surrounding the use of vivariums and animal welfare, along with the control of lab-generated waste.
On the upside, research and development in the sector is benefiting the environment in a positive way, through discoveries in agri-tech and the creation of biodegradable products.
What’s more, the potential for social value is exponential in terms of the impact on local and even global communities. The work undertaken in Oxford, for instance, to discover the Covid-19 vaccine has arguably delivered the greatest social impact seen in modern times. The pandemic aside, the work the sector does relating to curing disease and improving overall wellness cannot be overlooked.
So what about the “G”?
For most sectors, governance covers a company’s approach to how it does business. This can include anything from transparent accounting practices, to the implementation of policies on diversity and inclusion and avoiding conflicts of interest.
In the life science sector, however, for many companies there is another layer of governance to contend with. This can comprise how their facilities are set up and managed, how the equipment is validated, as well as the regulation of products that they bring to the market, such as drugs or gene therapies.
One key thing that the Covid-19 pandemic highlighted was the lack of vaccine manufacturing facilities. Add to this the growth of cell and gene therapy as an emerging sub-sector, the need for specialist space increases further still. These facilities (or specific laboratories within them) are heavily governed and need to follow the Good Manufacturing Practice requirements. This means that regulated facilities must be able to demonstrate that they have been designed and are operated in accordance with strict guidelines, so that the quality of the products or therapies being produced is guaranteed.
Space can range from a small suite of GMP quality-controlled labs as part of a wider scheme, through to a full manufacturing facility like the 140,000 sq ft Vaccines Manufacturing and Innovation Centre at Harwell. Yet, no matter the size, the scientific process design must be integrated with the building to ensure that the right conditions are provided.
For project managers and designers, this means that from the outset the process of design and construction must be properly planned, documented and signed off at each project gateway. The end goal meaning that the completed facility is approved by all the relevant authorities, such as the Medicines and Healthcare Products Regulatory Agency or the Food and Drug Administration.
There are four main governance phases for a facility that must be carefully project managed:
• Design qualification – verification that the design, procurement and installation meets the design intent.
• Installation qualification – has the equipment been installed as it should and in accordance with manufacturers’ requirements?
• Operational qualification – does the installed equipment operate as intended in various scenarios, such as different temperature ranges?
• Performance qualification – confirming that the installed equipment operates as it should by gathering calibration and validation data in real-life conditions.
Only once you have successfully delivered all of these phases can you run a compliant facility.
Through all of this, stakeholder management is also essential. Collaboration with specialist teams that will be using the space will allow project managers to understand how it will be utilised and ensure that this is fully integrated and accounted for within the design.
Given the focus on providing considerably more life science facilities in undersupplied markets, especially in locations such as London, we must make sure that we remember that ultimately, for life science firms, without the “G” there is no “E” or “S”.
Matt Soules is director and UK science lead at Savills
