A booming biologics market is increasing demand for specialist fill-finish services and prompting contractors to invest in technologies that reduce waste and safeguard these sensitive medicines.
The biopharmaceutical fill-finish market is growing 10% a year and will be worth $12.5 billion in 2027, according to a recent report by The Insight Partners. The key drivers, say the authors, are soaring demand for biologics and interest in dosage forms that improve patient comfort and compliance. Capturing a share of this growing market requires investment in technology and knowhow, says Peter Droc, head of Lonza’s drug product services unit.
“Overall, fill and finish operations must be designed with an awareness of the properties of the biologic products and the external factors that can affect their stability and behavior,” he tells GEN. To fill these requirements, special processes, procedures, and equipment must be in place to ensure product integrity during fill and finish manufacturing.
“Implementing innovative state-of-the-art equipment, such as robotic aseptic fill-finish isolator technology to enable a fully automated GMP filling process, can provide both standardized manufacturing and flexibility towards batch sizes.”
Automated technologies are particularly important when working with highly potent products like antibody-drug conjugates, according to Droc, who says minimizing human manipulation, reducing the risk of cross-contamination, and providing greater aseptic assurance are vital.
“An increasing demand to handle personalized medicine, highly potent drugs, products of high complexity level, and small batches is driving the need for automation in fill and finish. Factory automation systems enable AI and machine learning to be fully utilized, creating potential to improve every stage of the manufacturing process,” he continues. “AI and machine learning can enable smart equipment maintenance, better product development, and overall quality improvements based on proactive control as opposed to reactivity, thereby enhancing overall productivity.”
Examples of automation include the use of guided 3D vision cameras within isolator filling lines to minimize manual intervention, or high-resolution cameras coupled with AI solutions to monitor product defects.
Ultimately, it is the ability to collect data from fill-finish operations that is driving adoption of automation, notes Droc, who adds, “These systems collect large amounts of data about the equipment, the fill and finish process, and its environment. For example, a typical modern freeze dryer collects over 150 billion data points during its life span.
Enabling predictive maintenance
“During the process, reliable predictions regarding the status of assets and machinery can also be generated, enabling predictive maintenance. This may include peristaltic pumps during sterile filtration and filling processes, whose status can be detected more accurately and scheduled to reduce the overall impact on process efficiency and raw material wastage.”
In July, Lonza announced plans to increase biologics fill-finish capacity by setting up a large-scale commercial drug product facility in Stein, Switzerland. Automation and industry 4.0 technologies will be core to operations at the site, says Droc.
“We plan to implement the core technology that will support the aforementioned use cases in fill & finish at our Stein site to support our journey toward Pharma 4.0,” he tells GEN. “Leveraging this digital technology is critical to increase efficiency and preserve product quality as supply chains and manufacturing processes continue to grow in complexity. Leveraging data and AI will help us tackle these challenges to the benefit of our customers—and thus enable a healthier world.”
And the benefits of automation, AI, and digital technologies are worth the investment.
“Generally speaking, the initial investment for digital technologies may be higher than that of traditional fill and finish systems,” points out Droc. “However, over the entire lifetime of the systems and equipment, the advantage lies with digital technologies. They provide a significant decrease in the cost of production by minimizing errors and enabling better management of cost of goods.”