Advances in cellular biology have resulted in dramatic changes in the pharmaceutical industry during the past decade – including an increased emphasis on large molecule or biologic therapies. And while blockbuster drugs still have their place, new technologies have made more personalized, tailored medication a reality.
Scientific discovery does come with a price tag and manufacturing challenges, of course. For biotechnology companies, the issue is keeping up with the rapid pace of discovery – and delivering new products to patients quickly and cost-effectively within a highly regulated environment.
To meet these challenges, many have turned to single-use equipment, pre-validated skids and other flexible manufacturing approaches that enable production of low volumes of customized products at high rates of speed. These new “facilities of the future” can dramatically reduce startup time from the three or four years typical for a conventional hard-piped stainless steel facility to six to twelve months.
Featuring exceptional lab-to-production scalability, the facilities also minimize capital expenditures and related risk, since they can be quickly reconfigured to produce alternative products.
But creating a facility that pays dividends for years to come requires extensive planning. To maximize performance and flexibility gains, biotechnology companies must take a hard look at both the operation of their plant – and automation and integration strategies – beginning at the concept stage.
Here are two critical questions to consider at the outset:
How can automation systems be used to improve operator performance, minimize infrastructure requirements and ease regulatory reporting?
Any engineer accustomed to highly automated stainless steel pharmaceutical plants will be struck by the plug-and-play nature of mobile equipment in a single-use facility – and amount of manual intervention required. In fact, the production of a single batch in an upstream reactor might require 800 to 900 manual operations – from inserting the single-use bag to confirming the correct equipment, nutrients and tubing are in place. An error at any point during set-up could cause the batch to fail.
Automation systems can be used in a number of ways to help minimize the potential for error and improve verification methods. For example, automatic equipment recognition and verification systems can be integrated into the control platform to track and confirm equipment placement.
In addition, visual aids incorporated within the control system can guide operators through process steps and are a vast improvement over paper-based instructions.
Let’s say an operator needs to connect Point 1 to Point 4 on a transfer panel. Those points can be lit on an electronic interface along with the appropriate tube connection. Beyond visual guidance, the system can extend to verification. For example, it can instruct operators to input a serial number or scan a barcode to track material and equipment, which is automatically recorded in the batch record.
And thanks to advances in automation and information technology, manufacturers can achieve consistent visualization without a large infrastructure investment or multiple interface terminals.
Using the latest thin-client technology, workers can perform required operations using a tablet. Additional location detection features support mobility – and also help maintain security by verifying operators are in the correct place to perform certain tasks. Location resolvers like QR codes, Bluetooth beacons, Wi-Fi and GPS verify that mobile users and devices only receive content in authorized areas.
What is the best way to achieve integration and consistency across the entire facility?
At its core, a single-use facility is comprised of multiple process skids supplied by multiple equipment vendors. Typically, each supplier has a different control platform and different software set. And even within a specific OEM, different control systems may be used on different types of equipment.
The resulting “islands of automation” are a significant roadblock to consistent operation, maintenance and engineering across a plant. Operators must learn every system – and multiple spares and service contracts must often be retained.
In addition, without consistent data flows, data integrity and compliance can become problematic.
The path forward? More biotechnology companies and the OEMs who serve them are exploring an approach to integration based on a modern distributed control system that delivers a consistent structure – and consistent software set. This scalable and information-enabled approach promises extraordinary connectivity and flexibility.
In many ways, the outlook has never been brighter for biotechnology companies. An automation consultant who is familiar with single-use facilities and biologics manufacturing can help you determine strategies that can make your new facility truly future-ready.