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. And yet, the early design choices you make in your single-use facility can greatly affect your speed to market and ability to prove regulatory compliance. 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. And if your equipment isn’t designed to communicate between units of operation, setting up for production runs is an onerous process. For these reasons, you’re never too small to think big when it comes to your manufacturing ecosystem. By addressing future needs 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.

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• Facilities

• Design

• Engineering

• Manufacture

• Flexible Operations

• Pharma Manufacturing

• 6/1/2020

• Article