The development of such therapies requires specialised facilities and equipment, making it challenging for small biotech companies to easily scale-up their operations. This is when smart labs come into play, providing a plug-and-play modular approach that can accommodate cell and gene therapy (CGT) innovators at every stage of development.
In this article, Piers Slater, CEO of Reef group, and Raja Sharif, CEO of Hataali, discuss the development of smart labs.
Core need identification
The challenge with CGTs is that they require many new technologies that have been built to integrate into traditional pharmaceutical supply chains. For example, although digital technology has advanced in healthcare, it has not kept up pace in pharma; as such, we have innovations being used in biotech-based therapy development that are being combined with legacy systems and “old” IT.
As an industry, we have an opportunity to proactively build the infrastructure we need, so that the therapies in development today have the necessary resources available to take them to market as they approach late-stage trials. At present, logistical and supply chain challenges are prolonging development.
Taking a UK-specific view, we see opportunities to address this gap and the government has ambitions to be a big tech and science superpower.1 The existing paradigms are costly and rely on the development of a company’s own dedicated facilities or the use of a specialist contract development and manufacturing organisation (CDMO).
Managed smart lab facilities provide a new model to market. Smart labs could very well form the basis of this acceleration as they provide a third option to conduct costly development activities while also preparing innovators for scale-up and commercial launch.
The Reef Group's first step in this direction is the upcoming gene therapy facility for Autolus, a CGT biotech. Comprising more than 80,000 square feet of space to conduct advanced post-clinical manufacturing, the facility is being constructed using modular volumetric construction techniques, which has nearly halved the construction time.
Beyond this, the company has a pipeline totalling approximately 2.5 million ft2 in the aptly called “life sciences golden triangle,” including another 60,000 ft2 facility in North London for a company called Ascend Bio, also in the CGT sector.
In many ways, this development has occurred at exactly the right moment, with Stevenage in the UK emerging as the European centre for CGT manufacturing; as such, the town has a growing base of ATMP innovators.
According to Raja Sharif, companies operating in the UK life science are fully aware of the growth prospects and opportunities that this market presents, and these “impatient aspirers” would rather have a plug-and-play facility for their research than wait for the long buildout of bespoke premises.
Not to mention that this build route comes beset with a number of complex risks. Yet, smart lab modules take this a step further and transform these sites into fully automated and linked labs, providing a level of interoperability at the site level with other providers … or even globally. This is exciting for biotechs as they have a system in place that can take them from the lab all the way to post-launch success.
The operating model: how it works
In the case of Hataali’s SMARTLAB Module, the system is built on blockchain and is interoperable with manufacturing execution systems and lab software such as that of Miltenyi Biotec, Lonza and Biorad, to name a few. From a regulatory compliance perspective, such facilities, which are GMP/GXP-compliant, free up time and effort for start-ups by meeting these compliances in a serviced lab space.
These smart modules can be used by start-ups, spinouts or early development to late-stage CGT innovators who typically don’t have in-house facilities for scale-up. Interestingly, the facility can even house CDMOs who are expanding and need extra room for their increasing operations.
Slater emphasises that this approach is unique, providing fully fitted turnkey facilities with long-term leases funded by their partner (UBS). It was designed in collaboration with their construction partner, Merit, and their design division, UrbanR, for CGT occupiers such as Ascend. Essentially, they have delivered a space that is flexible enough for multiple occupiers and can be leased at short notice.
The smart lab works by essentially streamlining lab operations by automating lab ordering and stock inventory management, reducing the number of managerial staff required for these tasks and tracking the therapy in clinical trials. The product will be offered based on specific use cases to occupiers.
The smart component of these premised involves the digital linking of the labs to automate the procurement process — and the maintenance of records/information linked with the consumption of each lab.
The data analytics predict the use rate of consumable items, which reduces the wastage of media/reagents that often expire while sitting in refrigerators (owing to excess ordering).
The predictive nature of the tool helps the centre to buy more reagents that are regularly used at a better price — as bulk orders are cheaper — while helping the suppliers of lab reagents, media, laboratory gases and other consumables to improve demand planning and better ensure the availability of quality materials as needed.
Each box or bottle is RFID (radio frequency identification) tagged or tracked using Bluetooth; and, once the inventory crosses the prefixed threshold of used articles, the ERP (enterprise resource planning) in the central ordering facility of the institute reorders the materials to maintain a steady supply chain.
The advantage here is that the smart labs can therefore remove the need for procurement staff in the department as everything is automated.
Plus, the predictive analysis is not only able to forecast finish dates and order online, it can also purchase items at a date when there is enough space available in the refrigerated storage rooms to accommodate the expensive media and serum required by CGT labs.
Benefits for life science industry
A key benefit, which is not always obvious, is that a smart lab also reduces the environmental impact of the life science industry. Building labs with a focus on reducing carbon emissions also helps to futureproof facilities in terms of carbon taxes and regulations that may be implemented in the future.
Additionally, building labs with a focus on reducing carbon emissions and achieving net zero can also help to attract and retain talent that’s interested in working for organisations that prioritise sustainability and environmental responsibility. Moreover, this model is not unique to life science companies in the UK and could be “cut and pasted” globally.
Smart labs offer a solution to the continuously evolving biotech and pharma space. The elevated use of technology to monitor lab data, such as stock inventory, and then go even further to predict the rate of consumption will save innovators or CDMOs time and money.
This technology provides an economic advantage as lab reagents and other materials will no longer go to waste. This level of precision and real-time data is what makes smart facilities the “Labs of the Future.”
The smart model is a universally beneficial enhancement to the pharma supply chain and it can be replicated globally. With less human error and faster time to market for life-saving drugs and therapies, the innovative and efficient nature of smart labs will transform pharma supply chains on a global level … and patients will benefit as a result.
The potential for faster development times and more efficient use of resources will, in turn, lead to significant advancements in the field of advanced therapy.
Reference
- www.gov.uk/government/news/plan-to-forge-a-better-britain-through-science-and-technology-unveiled.