As a passionate organic chemist with a pragmatic mindset and hands-on approach the structure, layout and process landscape of laboratories have dominated my daily business for several years. During my studies as a Ph.D. Student in organic chemistry with major focus on homogeneous catalysis a high throughput of reactions including analyses, work-up and documentation has been necessary to achieve enough results. Eleven publications within three years, partly in high-impact peer-review journals, cannot be achieved without being well organized and time efficient.
However, being a quite ambitious and hard-working PhD is not a curiosity and nothing special in this business. How fine-tuned laboratories can look like has been demonstrated by my first industrial company experience at a medium-sized CDMO in Switzerland. Each single day the optimization of our laboratory processes has been of major interest.
As a Contract Development and Manufacturing Organization you need to have competitive prices, extraordinary speed, large extent of flexibility and of course a high aspiration regarding all quality aspects. Each minute searching for glassware, chemicals, lab consumables, writing reports, transferring samples from one space to another, reviewing results from e.g., GC or HPLC or analytical devices must be fine-tuned and absolutely time efficient. And handling kilogram scale reactions of a multi-step API synthesis at an industrial company is not comparable to a few milligram scale reactions at university with a minimum of documentation effort.
Optimised processes in the laboratory.
A few years ago, the methodologies of Lean Six Sigma, Operational Excellence, Kaizen, CIP, Value-Stream Mapping and Visual Performance Management appeared in the laboratory environment and every company started to follow or to adopt such strategies towards fully optimized process sequences with less waste, delays, duplication, defects or not assigned non-value adding activities.
Methods like 5-S workplace optimization and many others have been implemented across each laboratory and infrastructure as well as route planning have been optimized wherever possible. Positive results have been recognized within a very short period. Unfortunately, such small steps are no longer enough to compete with others in the 21st century. The change towards a digitally enabled laboratory is status-quo, industries best practice and already one hundred percent available.
The House of the Lean Laboratory.
With reference to figure 1, the key towards a digitally enabled, process fine-tuned lean laboratory is a strong and sustainable change mindset. In addition, since each QC laboratory is also part of the end-to-end process within the supply chain, the customer focus plays an important role as well. Without an efficient and fully transparent QC laboratory final batches cannot be released and patients will not receive necessary products on time in full. This is crucial whenever a QC laboratory is responsible for essential medicines for rapid patient treatment such as a Covid-19 vaccine, injectable generics such as sedative drugs, muscle relaxants and cardiovascular medicines or orphan drugs.
Within each level of the house of lean laboratory emerging technologies are listed. Visual performance management via digital dashboards, full system integration such as a LIMS-SAP linkage or electronic laboratory notebooks are only three examples.
Emerging technologies have the potential to revolutionize each single element of pharma manufacturing sites or quality control laboratories within the next five to ten years. Digitization and automation will also ensure better quality and compliance by reducing manual errors and variability, as well as allowing faster and more effective resolution of problems. As already mentioned, the quality control is an important function within a robust, reliable, and flexible supply chain. Thus, characteristics such as improved agility, shorter testing and increased transparency are best improvement levers towards the reduction of quality control lead times and faster release.
Unfortunately, many pharmaceutical or chemical companies have not yet fully exploited innovative technologies in terms of digitalisation and automation. Some attempts have been made to become paperless or to achieve better cross-functional linkage and transparency via a modern LIMS and ERP system. However, only a few companies have developed a long-term strategy for the development of digitised laboratories. How to assess the maturity of a large number of laboratories is shown in the figure below. The assessment of the QC gap and maturity level serves as a reference point for a neutral benchmarking of the innovation level of each QC.
QC Gap and Maturity Assessment across four Categories.
Based on figure 2, a quality control laboratory can be usually analyzed via four categories: 1) Processes and Organization, 2) Tools and Systems, 3) People and Interfaces as well as 4) CSV and Data Integrity. Within these overall categories different criteria are existing which can be individually assessed resulting in a kind of QC innovation level ranking and industry best practice comparison. To implement such an above-mentioned digitally enabled laboratory all features, technologies, personnel resources and infrastructure are a one hundred percent available nowadays. But what does it look like?
Approximately 90% of tests will still be performed in labs and some, the minority of samples, will be tested online. An automated data transcription between equipment and systems will take place and advanced data analytics will generate real-time data insights and optimized schedules on digital dashboards. Visual performance management, equipment utilization and all most important KPIs will also be transparent on laboratory dashboards. Laboratories will be 80% paperless with electronic signatures, electronic documentation and of course an electronic laboratory notebook. In addition, digital lab inventory planning and a fully transparent sample arrival for a more proactive planning of resources will be present. Experts such as data engineers and scientists will support the processes and advanced IT-systems as well as will help to capture, refine, and visualize the data. All these aspects sum up in a kind of general laboratory information management system (GLIMS). The single source of truth to run all processes and to make fact-based decisions. Like a quality control lab tower build in the pharmaceutical industry instead of the typical airport site. Digitally enabled labs use real-time key data analytics and visibility as well as ongoing process verification to track trends, prevent deviations or out-of-specification results and optimize scheduling. A laboratory for 2030plus can look like the following:
Laboratory landscape 2030plus. Digitally-enabled and Process fine-tuned.
- Elimination of up to 80% of manual documentation work
- Automation and, in particular, optimisation of planning and scheduling to improve staff, equipment and material utilisation
But what are the typical hurdles for such digitally enabled labs and why have these not been implemented across all companies so far? Ten typical implementation hurdles:
- Not having a clear vision of what evolution horizon is the right target for the lab
- Not having a compelling business case for the transformation
- Targeting a fully tested end-to-end future-state prototype rather than testing and rapidly scaling up high-value solutions to capture quick wins
- Lack of proper planning or management for roll-out of new systems or technologies
- Not having a full understanding of the capabilities of the systems and technologies
- Pursuing automation rather than optimization
- Self-imposed constraints from a perceived need to validate all systems
- Missing the skill set to extract full value from the data
- Spending too little time and effort on a sustainable change management
- Spending too little time and effort on a sustainable change management
How do you start?
The good news is that most of the required technologies to start the journey towards a digitally enabled lab already exist today. To successfully implement Industry 4.0 technologies, pharma companies need to set the right aspirations and move quickly. The next figure summarizes six key steps which need to be accomplished on the way towards an up to date, very competitive quality control laboratory.
Six Steps to start your Journey towards a digitally-enabled Laboratory.
In summary, modern technologies can make the quality control faster, more agile, and reliable, more compliant, and more efficient. By setting appropriate goals, choosing the right technologies, and scaling up quickly, pharma companies can become QC leaders and gain all the benefits and rewards in the form of speed, compliance, cost savings, and productivity improvements.
