From food and beverage to oil and gas, continuous manufacturing has long been accepted by a host of manufacturing industries to ensure the consistent delivery of high-quality product
Within the pharmaceutical industry, uptake has been much slower … despite the huge benefits that continuous manufacturing can offer the sector. However, it is now emerging as a key driver of building quality by design (QbD) into the complete product lifecycle — from R&D through to manufacturing — with the ultimate aim of getting safer medicines to market in a more efficient and cost-effective way.
The adoption of continuous processing within the industry has increased in recent years as pharmaceutical companies seek to optimise manufacturing processes and maintain high product quality. Using inline quality testing enables right-first-time production, thereby reducing waste and the time typically allotted for product testing, evaluation and batch review.
Yet, although the benefits of continuous manufacturing are clear, technology is also playing a key role in fostering innovation within the industry. For example, manufacturers are now able to scale-up their production volumes using the same equipment, accelerating the product’s time to market from R&D to clinical trials, large-scale commercial manufacturing and, ultimately, the patient. In fact, when compared with batch-based manufacturing, which requires a significant amount of quality testing, as well as sign off and product release, a product that is manufactured continuously can be made considerably quicker.
Of course, digitalisation is playing a huge role in helping many pharmaceutical manufacturers to unlock the benefits afforded by continuous manufacturing. The use of highly automated processes reduces the need for manual intervention and decreases both variability and human error. This permits real-time monitoring and continuous process optimisation, allowing for faster decision making — whether automated or manual.
Utilising a control system and seamlessly integrated process analytical technology (PAT), digitalisation can effectively ensure the product is right first time, reducing product waste. Furthermore, PAT enables real-time release, reducing the quality inspection time traditionally associated with batch manufacturing.
In response to this changing pharmaceutical landscape, Siemens recently partnered with GEA to enhance continuous manufacturing within the pharmaceutical and life sciences industry by offering a tightly integrated continuous tablet manufacturing line. The collaboration delivers both production benefits in terms of reduced project execution risk, higher quality and cost-effective manufacturing, and customer benefits in the form of seamlessly integrated technologies, expertise and support.
GEA’s ConsiGma continuous manufacturing platform is equipped with a Siemens automation solution, including SIPAT for data management. The combined technologies offer both wet granulation and direct compression in a standard-setting solution for continuous tablet production.
In addition, the ConsiGma continuous tableting line is a multipurpose platform that has been designed to transfer powder into coated tablets in development, pilot, clinical and production volumes in a single compact unit. The system can perform dosing and mixing of raw materials, wet or dry granulation, drying, tableting, coating and quality control, all in a single and integrated line, allowing for real-time release and testing so that final quality inspections can be reduced or eliminated.
This allows pharmaceutical companies to continuously process and manufacture oral solid dosage forms, such as tablets, offering significant reductions in development time and raw material use, further decreasing process and energy costs while maintaining quality and increasing manufacturing efficiency.
However, although much of the pharmaceutical industry is beginning to understand and actively explore the ways in which continuous manufacturing can effectively overcome customer challenges, there is still a disconnect that needs to be addressed. As a way to educate the market and ensure continuous manufacturing remains at the forefront of the industry, a number of collaborative organisations have been formed.
The Continuous Manufacturing and Crystallisation (CMAC) future research hub at the University of Strathclyde in Glasgow, UK, brings together leading pharmaceutical companies and technology providers to share best practice and expedite projects from pilot through scale-up. As an active member of CMAC, Siemens is collaborating with pharmaceutical end users and technology providers and helping to transform current manufacturing processes into the medicine supply chain of the future.
With the use of continuous manufacturing set to increase in coming years, now is the time for pharmaceutical manufacturers to partner with OEMs, technology providers and end users to truly leverage the opportunities that continuous manufacturing presents. And, with production costs typically offering a 10–20% saving when moving to a continuous model compared with a like-for-like batch process, it offers an immediate saving to businesses.
Of course, it’s not an overnight switch. There does need to be an approval process in place and, significantly, regulators — including the US FDA — are now approving more medicines that have been produced using continuous manufacturing than ever before. It means that the barriers that once existed are being removed, enabling pharma companies to produce more affordable drugs in a shorter timeframe without compromising on quality.
In a challenging industry landscape, pharmaceutical manufacturers must adapt manufacturing processes to meet current demands to remain profitable and meet patient needs. Continuous manufacturing is playing a vital role in meeting these objectives by delivering higher productivity, flexibility and lowering the cost of quality.