Lab Automation: Integration of Legacy Equipment 

The pharmaceutical sector is characterised by intricate processes, stringent regulations and a constant demand for innovation. However, the industry's digital transformation is hindered by the prevalence of legacy machinery, which often poses compatibility challenges when deploying new technology. COPA-DATA explains the method of standardisation to remove the barriers of integration of legacy equipment in labs and production lines

Bernhard Korten at COPA-DATA

Innovation is the lifeblood of progress, but the equipment limitations of some life sciences environments are hindering the sector’s ability to meet industry demands. Chief among these demands is the urgent need for shorter innovation cycles in drug manufacturing. The relentless pace of drug discovery demands a nimble and adaptive approach to research, development and, ultimately, production: many labs and production lines are not prepared to adapt quickly to new production runs.

The rising demand for customised medicines is also creating pressure. Patients are increasingly seeking tailored therapeutics that cater to their unique genetic make-up and medical conditions. Personalised medicines are also being spearheaded by governmental bodies, of which there are currently 28 policies by the European Union (EU) aimed at improving public health through personalised medicine implementation.

Regardless of the positives of these initiatives, Europe’s facilities for developing and manufacturing these medicines are simply not ready. This feeds into the larger challenge of Europe’s life sciences industry and its ability to compete on a global scale. In addition to the dominance of the US, there is rapid growth in the market and research environment in emerging economies such as Brazil, China and India. This is leading to a gradual migration of economic and research activities from Europe to these fast-growing markets. In fact, during the period between 2016 and 2021, the Brazilian, Chinese and Indian pharmaceutical markets grew by 11.7%, 6.7% and 11.8% respectively, in comparison to an average market growth of a lesser 5.8% for the top five EU markets. As a result, cost control and budgeting remain an ever-present challenge in life sciences. This is particularly challenging in drug development, where research and trials expenses can escalate rapidly and are dependent on external funding.

A technological solution

Modular production presents a compelling solution to these issues. In a life sciences context, modularisation involves breaking down either production or lab systems into smaller, interchangeable modules that can be easily assembled and disassembled. The modular approach offers several advantages, including improved production flexibility, greater efficiency and increased scalability. A key advantage of the modular approach is that it allows for rapid reconfiguration of manufacturing lines or laboratories. This unlocks the ability to accommodate for a greater number − and a greater variety − of production processes. In turn, unlocking the potential for more types of medicines.

In addition to flexibility, modular production can also be more effective from both a time and cost perspective. Breaking a facility down into smaller modules means they can be optimised and self-contained for specific tasks. For instance, filling and capping machines are essential for automated filling of vials, bottles and syringes, but these machines may not be necessary for every production run. The ability to redeploy this equipment for alternative processes means productivity is increased. Likewise, applying this methodology to energy-intensive production equipment such as lyophilizers or fluid bed dryers, can significantly save energy costs.

Barriers to modular production

Despite its perceived advantages, modularisation is not without its challenges. One hurdle to overcome is compliance with the industry’s stringent regulatory standards. Any modifications or additions to the production process must adhere to the necessary regulations. Additionally, validation and qualification of each module in a modular system can be complex. Each module, regardless of its role in the system, must undergo individual validation and qualification processes. This can be time-consuming and costly − particularly when dealing with a large number of modules.

Interoperability is another colossal challenge for the life sciences sectors. Integrating equipment from various manufacturers into a cohesive system can be problematic. Often, labs and production environments will use a vast array of equipment, varying in age, original equipment manufacturer (OEM) and communication protocol. Seamless communication and interoperability among modules are essential for modular production to be successful.

Modularisation for equipment manufacturers

Modular production is not only advantageous for medicine manufacturers and lab owners; it can also be a game-changing technology for original equipment manufacturers (OEMs) catering to this market.

The process begins with the delivery of an essential component that serves as a comprehensive descriptor of the equipment’s functionality that follows the semantics outlined by the industry standard. To complete the integration, all signals from the equipment must be exposed to an OPC UA server, which acts as the bridge to the process orchestration layer (POL).

There are already multiple examples of global OEMs integrating these modular programmes into their equipment. MG2, the Italian manufacturer of processing and packaging machines for the pharmaceutical industry, has deployed this technology in its capsule filling machines. These machines have the capacity to connect to company-wide networks through standardised modules such as OPC UA servers, domain authentication, time server synchronisation, automatic SQL Server database batch transfer, automatic network database backup, centralised batch report generation and many more.

Cytiva, previously GE Healthcare Life Sciences, is another example. As a global provider of technologies to develop novel therapeutics, Cytiva equipped one of its chromatography systems with modular functionality. In practice, this sees a complex device included in a POL at the click of a button, enabling a user to incorporate it into any new or existing production run in a straightforward way.

Modular drug development

In pursuit of accelerating time to market, employing modular technology can speed up drug development processes. Companies need a methodology to facilitate swift system configuration changes and seamless upscaling across equipment inventory. Key goals should be to empower lab technicians without programming skills to effortlessly integrated modules into their trial setups and to ensure maximum flexibility and time savings, ultimately streamlining processes. Any organisation hoping to deploy modular production must consider the engineering challenge of adopting modular systems. Technicians and engineers must adapt to work with interconnected modules rather than static production lines. This demands a deeper understanding of automation technologies than they may be used to, so leaning on the expertise of modular technology providers will be essential to bridge this knowledge gap.

The future of modularisation

As the life sciences industry continues to feel the pressure of achieving shorter, faster, more efficient cycle times, modular production may be a promising solution. This methodology promises to reshape the landscape of drug development and production, offering a bridge between legacy equipment and cutting-edge technology.