Pharmaceutical Analysis

Build the Lab of the Future Today for Pharma 4.0

Pharmaceutical companies can be more cost-efficient, more connected and more productive with Pharma 4.0 by modernizing the laboratories. The transformation into the Lab of the Future necessitates the use of digitalization and connectivity. In this article, Eric Grumbach, Director of Pharma / Biopharma Vertical Marketing at Thermo Fisher Scientific discusses the new innovations in analytical instruments that can help support lab professionals on their journey to Pharma 4.0.

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In the pharmaceutical industry, which is already grappling with costs and efficiency pressures along with aspirations to achieve higher scientific and regulatory standards, Pharma 4.0 holds hope for drug manufacturers, particularly in Asia’s highly competitive marketplace.

Pharma 4.0 embodies a risk-based approach to improve the quality and safety of drugs throughout the journey of a molecule from drug substance to drug product. The instrument-to-human connectivity is enhanced, ensuring that the transition to a more digital environment will help distil insights from complex data, predict problems before they occur, and proactively anticipate challenges and deploy countermeasures with minimal human intervention.

Overall, the implementation of a Pharma 4.0 framework will lead to improvements in connectivity and information sharing, to improve the productivity and compliance of laboratory-driven organizations while modernizing their infrastructure and improving costs. Digitalizing information, which improves data traceability, will lend itself well towards maintaining and improving a company’s data integrity initiatives.

Journey to Pharma 4.0
The journey from its current process to digitization and modernization will not happen overnight. However, these concepts do provide the opportunity to modernize at a pace which is appropriate for each company.
By taking advantage of technology that is available today, laboratories within the pharma industry can migrate to Pharma 4.0 by becoming more digital, and less dependent on paper-based workflows, and in so doing, improving the security, compliance, and integrity of their data. In addition, novel informatics platforms can harness the wealth of information being produced within the laboratory and production environments, to make informed decisions through advanced data analytics.

Over time, automation and real-time testing will become more prominent. However, the pace of adoption will be dependent on each individual company. With that said, there are significant cost, productivity, and compliance advantages for laboratory-dependent organizations that embrace digitization more quickly. Companies such as Thermo Fisher Scientific are actively developing and implementing new digital tools to help support laboratories in transitioning to Pharma 4.0.

The Lab of the Future for Asia’s Pharma Industry
In tech-savvy Asia, the Lab of the Future necessitates an increased connectivity between several networked components, instrument sensors, and staff across the laboratory or manufacturing facility. In many cases, the creation of a digital twin of the physical system helps contextualize how to interact with, or troubleshoot, the physical device through enhanced connectivity.

The most important aspect to prepare for this transition is to map out the implementation strategy, establish champions for your company’s project, and create a culture of accountability to help manage this large shift in mindset.

Three key steps include:

  1. Analytical instruments and software that are easier to use, troubleshoot, and service will help labs to improve efficiency, productivity, and profitability. In short, achieve the same (or higher!) monthly productivity targets with the same or fewer resources.
  2. Leverage remote-monitoring and predictive-maintenance capabilities in analytical instruments to reduce or eliminate unexpected downtime, thus improving total cost of ownership.
  3. Invest in enhancing connectivity within the in-house laboratory environment, and with the greater scientific or pharma community.

German-headquartered Arevipharma tested a new smart-connected HPLC system and is pleased with its advanced features. “My favourite feature is that I can monitor the instrument remotely. I no longer start a sequence and have the instrument run dry during that sequence,” said Matthias Drunk of Arevipharma. He added that the user interface can show him if the measurement is on-going or if it is idle, enabling him to make informed decisions for the next steps.

The HPLC system that Arevipharma trialled had videos embedded within the user interface to help guide analysts on simple procedures such as installing a column or changing a check valve. If something does go wrong, step-by-step guided diagnostic tests allow the user to quickly and effortlessly find the source of the error.

For laboratory professionals, such cutting edge HPLC systems offer dependability, robustness, and productivity as the key foundational elements for an exceptional user experience. Built-in system intelligence can ensure that unscheduled downtime is eliminated or prevent samples from requiring re-analysis due to deviations in results. Systems built for Pharma 4.0 are designed for reliability and robustness – the average cost per repair can be 30% less than an equivalent LC system!

Laboratory users do not need to invest hours in complicated guides to implement new systems due to the intuitive user interfaces and video instructions to guide analysts on operational procedures or run diagnostic tests to address errors. Additionally, it is easy to service or replace each module without destacking the LC components.

Modernizing the laboratory will not only make it more efficient, but also improve time-to-market while reducing costs.

The Future Made Simpler
The cumulative benefits of the digitalisation and connectivity deliver results in cost savings, reduction in human errors and an improvement in the overall safety of the working environment.

Laboratories looking to start their transition towards a successful future in Pharma 4.0 can get a step ahead by investing in the systems that provide them with the ease, benefits, reliability and cost benefits to build their Lab of the Future, today.

Lab professionals recently participated in knowledge exchange forums such as the 'Pharma 4.0: Transforming Pharmaceutical Manufacturing in the 21st Century'. This was held in September 2020 and was specially designed for pharma manufacturers, laboratory professionals and the scientific community in Asia.

This series of forums and discussions are now available on-demand. I invite you to view them here.

Author
Eric Grumbach_80Eric Grumbach 
Director of Pharma / Biopharma Vertical Marketing at Thermo Fisher Scientific

 



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