By Dan UpDyke, market development manager, Life Sciences, Rockwell Automation, and Timothy Wortley, senior product manager, Bioprocess Industrial Automation, Cytiva, formerly GE Healthcare
You may not be thinking about the future scale-up to commercial production when you’re in the early stages of crafting a new biologic therapy. But it is prudent to keep your long-term production needs at the front of your mind.
That’s because the early design choices you make in your single-use facility can greatly affect your speed to market and ability to show compliance throughout regulatory reviews. These decisions can also impact your production flexibility for future growth.
Securing FDA approval may prove more cumbersome if processing data is not automatically collected. You might need to sift through years of hand-written and difficult-to-isolate data to identify the required information. And if your equipment isn’t designed to communicate between units of operation you may find that setting it up for production runs is a long and onerous process.
For reasons like these, it’s important to remember you’re never too small to think big when it comes to your manufacturing ecosystem. By addressing future needs like regulatory approvals and operating efficiencies early with smart process design, you can scale your operations from development to production with minimal disruption, and be better prepared for future products and expansion.
Future-proofing your single-use production strategy doesn’t equate to major up-front capital investments. You just need the right design philosophy, one that’s built around integrated, standardized equipment, and automated data collection.