Digital: Cloud Software in Pharma Development

Could the Cloud be the catalyst many pharma QC labs need in their race to the Lab of the Future?

Kate Wearden at Waters

‘Lab of the Future’ – aterm many pharmaceutical quality control (QC) labs are now familiar with – encompasses many elements and is a prime example of the well-known adage ‘the sum is greater than the whole of its parts’. Automation, digitisation, the Cloud, artificial intelligence (AI), machine learning (ML), the Internet of Things (IoT), analytics and more are all part of this potential minefield of innovation. Though if not implemented with a clear focus, this adoption of new ways of working has the potential to cause significant disruption to the operations of an organisation. However, according to Katrina Costa, science writer at Open Pharma Research, the focus should be on ‘drive[ing] greater scientific innovation, and ultimately get[ting] the right medicines to patients, faster’. 1

Speed-to-market is undoubtedly a significant element of Lab of the Future, however it’s potentially not the only element for many labs. In a study conducted in 2022, it was found that 72% of labs identify the ability to support new science and innovation as a key driver towards digitisation.2 Regardless of the specific goal of each organisation, pursuing the Lab of the Future is necessary when dealing with the fast-paced environment and increasing challenges facing pharma QC labs. Rising consumer demand and limited resources have resulted in a need for labs to confront a rapidly evolving business landscape, where compliance and data quality requirements for products must be met within tighter timelines and smaller budgets.

Evidence shows that labs are taking steps towards Lab of the Future to combat these challenges. Accenture reported that in 2021, 91% of labs were moving towards digitisation vs 37% in 2019.3 Taking that leap towards Lab of the Future can be daunting, particularly in the face of emerging technology like ML. However, one tool labs seem to be embracing in their journey to Lab of the Future is the Cloud. Dominant in our homes, the Cloud is now providing similar benefits in the lab, and while we aren’t yet at the stage of voice-activated assistance, we are ultimately seeing the benefits the Cloud can offer when it comes to supporting the day-to-day operations of the lab and increasing operational efficiency.

The journey to the Cloud

When looking more broadly at the digital journey faced by many pharma labs, two elements are the driving force behind the need to change. The first is scientific acceleration. The pharmaceutical industry is faced with the increasing pressure to find new solutions that both support human health and deliver these solutions, quickly and safely. Closely related, the second driving force is the need for efficiency and productivity − the pressure to do more with less is greater than ever and, as a result, labs are continually looking for ways to increase their output. While the Cloud can support scientific acceleration, arguably the largest benefit of moving to the Cloud is to support efficiency and productivity. The following are some of the key efficiency challenges that are increasing the drive towards the Cloud specifically.

The need to be more connected

The COVID-19 pandemic significantly accelerated the need for pharma and other labs to adopt ways of working that supported a more connected workforce. The lab itself became quieter, with more people working off-site. It became important to investigate newer ways of collaboration that were not dependent on physical proximity to each other or the lab. Although now, through the pandemic, the benefits of connectivity have been recognised and in many labs, they continue to be adopted as the new way of working.

The need to make data work harder

Analytical data is one of the most important assets of any lab, however any data is only valuable if those who need it have access to it and use it to inform decision-making.

Adopting the Cloud can facilitate data sharing and decision-making, as silos are reduced and different data sources are connected. The same can be said for telemetry data, which is important in enabling labs to analyse the efficiency and productivity health of their laboratory.

The need for flexibility

Perhaps one of the largest challenges labs face is the increasing need to be agile and adapt to the changing environment. A significant part of this challenge is the need to scale, often quickly, when required. This was well demonstrated by the recent COVID-19 pandemic. The ability to access new digital tools easily and quickly is critical when the need to rapidly scale arises. Unfortunately, this is not currently possible with traditional digital delivery mechanisms.

The need for financial resilience

The current economic environment poses challenges for all industries, making it essential for organisations to support their financial resilience. As part of this, many organisations are looking to obtain more balance between their capital expenditures (CAPEX) and operating expenditures (OPEX). Operational expenditure like Software-as-a-Service (SAAS) tends to have a lower upfront cost and can help increase the predictability of financial expenditure while also increasing financial flexibility. The final element, and perhaps the most significant to have encouraged the adoption of digital solutions in similar ways to the Cloud, is Pharma 4.0, or the fourth industrial revolution.

The fourth industrial revolution

The International Society for Pharmaceutical Engineering (ISPE) originally introduced the concept of Pharma 4.0 in 2017, aiming to implement new Industry 4.0-based manufacturing concepts into the pharmaceutical sector. Often termed ‘the fourth industrial revolution’, the ISPE predicts that: ‘Pharma 4.0 implementation will more likely resemble an evolution in which digitalisation and automation meet very complex product portfolios and cycles.’4 Ultimately, what Pharma 4.0 represents is a significant period of change for the analytical laboratory.

However, implementing elements of Industry 4.0 will not happen overnight. For successful adoption into the regulated pharmaceutical industry, technologies need to be well-matured. For example, digital tools such as ML, and to some extent AI, are not yet mature enough for adoption into the pharma industry. Despite this, several Industry 4.0 technologies are already being implemented in pharmaceutical labs − the Cloud being one of them. Developing a more connected pharmaceutical laboratory through implementation of the Cloud can be challenging, particularly from a regulatory perspective: increased connectivity has the potential to increase vulnerability. However, from what we’ve seen so far, the benefits far outweigh any perceived risk. When the appropriate safeguards are put in place, increasing connectivity can actually have a positive impact on labs, enabling them to easily adhere to regulations as transparency, communication and ways of working are improved.

The potential for further benefits is also increasing as those developing these new tools and technologies direct more focus towards the complex needs of regulated manufacturing. IBM believes the Cloud to be a critical element of Industry 4.0, highlighting that ‘realisation of smart manufacturing demands connectivity and integration of engineering, supply chain, production, sales and distribution and service. [The] Cloud helps make that possible.’5 It is clear that the benefits of the Cloud and other digital tools are already being realised within the industry.

The future is connected

Lab of the Future, Pharma 4.0 and digitalisation are all hot topics within the pharmaceutical industry today as pharmaceutical organisations strive to achieve two of their most critical goals: scientific acceleration and productivity, and efficiency. However, travelling through this minefield of technology is undoubtedly daunting and assessing the value of implementation vs the potential disruption and risk to quality is an even bigger challenge. For the most part, it is a challenge the pharmaceutical industry seems to be embracing. By simply taking the first step and implementing technologies like the Cloud, their journey to becoming a smarter, connected lab is supported. While the implementation of a new technology may bring some turbulence, the long-term benefits of adopting solutions such as the Cloud undoubtably justify the effort, and in many cases the effort may not be as much as first anticipated. The pharmaceutical industry is now benefiting from the maturity of Cloud technologies, making implementation simpler, maintenance easier, reliability stronger and security more robust. This will ultimately allow labs to reduce silos, expand their capacity and collaborate more easily. For those organisations yet to embark on their journey to the Cloud: now is the perfect time. Embracing connectivity at any scale within the pharmaceutical laboratory is a critical milestone on the road to becoming a Lab of the Future.

References

1. Visit: lab-of-the-future.com/2020/12/19/insight-unleashing-the-power-of-digitalisation/
2. Visit: mckinsey.com/industries/life-sciences/our-insights/digitization-automation-and-online-testing-embracing-smart-quality-control
3. Visit: accenture.com/us-en/insights/life-sciences/digital-labs
4. Visit: ispe.org/initiatives/pharma-4.0
5. Visit: ibm.com/topics