Continuous manufacturing has long been accepted by a host of manufacturing industries from food and beverage to oil and gas, where it ensures the delivery of a consistent and continuous quality of product
Within the pharmaceutical industry, uptake has been much slower, despite the huge benefits continuous manufacturing can offer the sector. However, it is now increasing 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 manufacturing within the sector has increased in recent years, as pharmaceutical companies are seeking to optimise manufacturing processes and maintain high product quality. Using inline quality testing enables right first time production, therefore reducing waste and the time typically afforded to product testing, evaluation and batch review.
Yet, while the benefits of continuous manufacturing are clear, technology is also playing a key role in fostering innovation within the industry. For example, manufacturers are able to scale up their production volumes using the same equipment, speeding up the potential time to market for the product from R&D to clinical trials and on to large scale commercial manufacturing, and ultimately the patient. In fact, when compared to batch manufacturing, which requires significant quality testing, as well as sign off and product release, a product that is manufactured continuously can be made significantly quicker.
Of course, digitalisation is playing a huge role in helping many pharmaceutical manufacturers unlock the benefits afforded by continuous manufacturing. The use of highly automated processes reduces the need for manual intervention, variability and even human error. This permits real-time monitoring and control optimisation for continuous processes, allowing for faster decision-making both automated or manually.
Utilising the control system and process analytical technology (PAT), which is integrated seamlessly, 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 with 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 and Industrial IT 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 tabletting 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, tabletting, 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 (API) use, further decreasing process and energy costs while maintaining quality and increasing manufacturing efficiency.
Yet, while 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 brings together leading pharmaceutical manufacturers and technology providers, enabling projects to be piloted and scaled up quicker, with best practice shared.
As an active member of CMAC, Siemens is collaborating with pharmaceutical end users and technology providers, 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 OEM’s, technology providers and end users to truly leverage the opportunities continuous manufacturing presents. And with production costs typically offering a 10-20% cost 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 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 pharmaceutical companies to produce more affordable drugs in a shorter timeframe without compromising 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.