COVID-19 has taught businesses many lessons and some of these were learned the hard way. Perhaps the most valuable lesson was the value of preparation.
For manufacturers, the pandemic put a spotlight on the urgency for digital transformation and processes automation to prepare for the next crisis. The State of Smart Manufacturing Report[1] by Plex Systems, a Rockwell Automation company, revealed that smart manufacturing adoption accelerated by 50% globally in 2021, and these new technologies are now solving the industry's critical challenges. Asia-Pacific (APAC) organizations (93%) view smart manufacturing as "very" or "extremely" important to future success, compared to North America (NA) (84%) and Europe, Middle East, and Africa (EMEA) (75%).
However, digital transformation is no easy feat and comes with multiple challenges. This is especially true in a pharmaceutical manufacturing setting.
The pharmaceutical industry has stringent regulatory compliance needs, highly complex processes, and sensitive ingredients needing sterile production environments. Biologic manufacturing has even stricter regulations to ensure drug safety and efficacy.
Flexible and highly efficient factories are needed to improve productivity and efficiency in pharmaceutical and biologic manufacturing. This is especially so as the world faces a growing number of diseases that requires a wider variety of treatment to be produced more quickly.
Key challenges in pharma or bio manufacturing
Pharma and biotech manufacturers are operating in an increasingly competitive and fast-moving environment, and face multiple challenges including:
- Inventory mismanagement: Many companies still use manual processes for routine operations, including inventory management. This leads to incorrect charging of materials and consumables on the shopfloor and sometimes a shortage of materials within the warehouse and manufacturing facilities.
- Human error: Many companies still use paper batch records for documentation of their processes. This can lead to data entry issues, missing signatures, incomplete information, etc. Minor errors such as increased turnaround times, unnecessary spending, and errors can quickly lead to confusion and potentially even jeopardize patient health. Human error can cost pharma and biotech businesses from US$25,000 to US$55,000, topping US$1,000,000 or more per error if product loss is involved.[2]
- Long R&D processes: The pharmaceutical industry is characterized by capital-intensive and lengthy R&D processes. Improving, standardizing, and automating processes can result in higher overall R&D efficiency.
- Regulatory inspections and compliance: Pharmaceutical companies face the challenging task of complying with regulations across all aspects of their business in every market they operate in. The pressure to stay compliant with regulations drives pharma and biotech manufacturers to increase transparency and adopt innovative digital technologies.
A Manufacturing Execution System (MES) connects, monitors and controls complex manufacturing environments and data flows on the factory floor. They help pharma manufacturers overcome these challenges and enable them to move away from paper-based operations.
This can help businesses improve plant productivity, track and synchronize plant resources, and empower business systems and people with real-time information about what is happening across the production. This reduces risks, time to market, production costs and increase process efficiency and product quality.
Eli Lilly and Company, a global healthcare leader, provides a great example of MES benefits. The company wanted to address the gaps and overlaps between its Information Technology (IT) and Operational Technology (OT) domains which caused issues like production stoppages and cost-overruns for solution deployments. Using a MES, the company developed an IT/OT partnership, helping drive the company’s global serialization program.
This enabled it to steward a global solution to provide regulatory-mandated traceability for all final product units. The solution converges IT and OT domains by integrating vision systems, high-speed control, event management systems and Enterprise Resource Planning (ERP) systems.
Through its IT and OT collaboration, Eli Lilly and Company also developed an understanding of industrial cybersecurity risks, with a plan to mitigate immediate risks and an ongoing strategy for best-available protection.
How can manufacturers benefit from an MES?
A MES plays a fundamental role in the digital transformation process of pharmaceutical & biotech organizations. Here are some of the benefits:
- Automating real-time data recording: Using a MES, pharma and biotech manufacturers can automatically capture real-time data on every process step, enabling standardization of processes and speeding up decision-making.
- Digitization of production processes: A MES eliminates the need for paper-based Standard Operating Procedures or records and equipment and material labels, significantly reducing inaccurate, unreliable information, human error, and delayed implementation of corrective actions.
- Simplified production: A MES centralizes production data in context, and quickly and easily recognizes deviations from performance targets to understand the root cause of operational issues.
- Operational excellence: Implementing an MES not only increases the efficiency of the production line by maximizing asset utilization and reducing scrap and waste; it also helps increase production quality and customer satisfaction.
- Review by exception: A MES enforces controls throughout the manufacturing process to ensure that each batch is produced within a controlled set of parameters space. This is especially important for critical process and quality attributes. Utilising a MES means reviews can focus on exceptions rather than the entire batch record.
- Regulatory compliance: A MES is a solution that provides better visibility and transparency of manufacturing processes and promotes regulatory compliance. This enables businesses to take control of their vendor compliance, product safety, genealogy and traceability with better reporting and documentation.
- Improved cybersecurity: MES applications are embedded with multi-layered protection systems committed to reducing risk, safeguarding data, and monitoring threats. This ensures security at the data source and protects data integrity throughout the value chain.
Cytiva, is a global provider of technologies and services that advance and accelerate the development, manufacture, and delivery of therapeutics. It wanted to create a connected digital enterprise to help improve internal operations and decrease time-to-market for end customers. Using a MES, Cytiva not only reduced its time-to-market but also increased its production throughput, availability and production efficiency by 10 to 20% and decreased its energy use, scrap material, batch release time, maintenance and downtime investigations by 5 to 30%.
Transform manufacturing with an MES
As manufacturers embark on their digital transformation journeys, finding the right MES partner will make all the difference. A well-versed MES provider can help design and implement customized solutions to meet the manufacturer's or manufacturing facility's specific needs. Pharma and biotech manufacturers will also be able to leverage the MES vendors’ understanding, experience and in-depth knowledge of industry-specific products and shop-floor processes.
The right MES software can be a game changer for pharma and biotech manufacturers, providing greater visibility and transparency into manufacturing processes, promoting compliance, lowering operating costs, and improving productivity and quality.
Originally published in BioSpectrum Asia.
By Marcelo Tarkieltaub, Regional Director, Southeast Asia, Rockwell Automation
[1] https://www.plex.com/resources/7th-annual-state-of-smart-manufacturing
[2] https://www.pharmaceuticalonline.com/doc/reducing-human-error-in-gmp-pharma-biopharma-operations-0001
