In recent years, leading biopharmaceutical manufacturers have started testing the use of small batches to produce highly custom pharmaceuticals developed from research on genetic variations. It’s an important advancement in the medical field, as customized products can help healthcare professionals provide more targeted and personalized care to their patients. As such, it’s become a high-priority area for pharmaceutical companies, and according to the FDA, more than 40 new products utilizing gene therapies may be approved by the end of 2022.
However, customized products are often much more complicated to produce than standard mass market pharmaceuticals. Production can become more time-consuming, and products must be tested and tracked rigorously. When batches have even slight differences, any issue with quality control can have disastrous consequences. Plus, it may be difficult or even impossible to track long-term market demand for high-precision products.
To improve their operational efficiency, there are a few areas small batch manufacturers should focus on. With these strategies, plants can help create the valuable, customized products our healthcare system needs without impeding their internal processes.
Gather Extensive Data
When looking for ways to improve efficiency, the best tool manufacturers can give themselves is data. For biologics manufacturers working with small batch precision medicine, advanced technology is a necessity to gather ample production data and gain a complete understanding of their operational capabilities. This data can help point to inefficiencies, bottlenecks, and opportunities within the plant.
To gather a more comprehensive set of data, plants will need to begin integrating a variety of tools and software. Devices such as smart sensors can be added to existing equipment to provide real-time insights on their performance. Even if your organization can’t invest in sensors for the entire plant upfront, gradually implementing them over time will still provide helpful additional data.
Some manufacturers have also utilized blockchains to track products through their life cycle and ensure each batch is safe from contamination or other damage. In addition to providing added security, using blockchain can also provide companies with valuable data throughout their entire supply chain. However, only about one in four pharmaceutical manufacturers have implemented blockchain technology, according to research from the Association for Packaging and Processing Technologies.
Implement Flexible Tools
In the process of gathering data, many manufacturers discover they have the capacity to produce more small batches of custom pharmaceuticals, but their current processes and schedules aren’t properly aligned to achieve their goals. Organizations in this situation can significantly benefit from processes that support increased flexibility during production. When manufacturing schedules can be quickly adjusted as needed, it gives plants the ability to respond to changes in demand in real time.
To give themselves more flexibility, some pharmaceutical plants have shifted away from batch manufacturing and instead use continuous production to reduce hold times that can cause longer delays. In recent years, continuous production has emerged as an optimal strategy to fit the needs of small batch precision pharmaceutical manufacturing. The FDA and other experts have also recommended pharma plants switch to continuous production models.
VirtECS®, our advanced planning and scheduling tool, is an ideal tool to analyze how plants can implement their own continuous production plan. VirtECS® is backed by decades of research and has helped numerous pharmaceutical manufacturers optimize their facilities across the world. Additionally, in the process of creating optimized schedules, VirtECS® also captures valuable data that can be used to further improve internal processes. To find out more about continuous manufacturing and the role we can play in optimizing production, check out our other articles here.
