In today’s changing biopharmaceutical industry landscape, companies that consider manufacturing flexibility, speed to market, and cost efficiency foster success. With growing demand for innovative therapeutics, contract development and manufacturing organizations (CDMOs) play a crucial role in enabling the development and production of life-saving drugs. For CDMOs, maintaining flexibility while ensuring optimal efficiency in manufacturing is a delicate balancing act. Enter Batch 360™ service, our comprehensive service offering designed to streamline single-use technology (SUT) integration and process optimization.
Are you a manufacturing science and technology lead, manager, or director looking to enhance your SUT implementation or navigate single-use biomanufacturing challenges? Batch 360™ service provides invaluable support to optimize your processes. Keep reading to discover how Batch 360™ service can help you reduce time to market, improve operational flexibility, and ensure robust, scalable solutions.
Why single-use technology matters for CDMOs
Over the past two decades, single-use biomanufacturing technology has become a game changer, offering unparalleled advantages in reducing capital expenditures (CapEx), optimizing engineering costs, and enhancing bioprocess flexibility. As rapidly meeting client needs and adaptable production becomes increasingly critical, SUT continues to transform how facilities operate. This is where the Batch 360™ service, part of our FlexFactory™ platform solution, delivers exceptional value.
Key benefits of SUT:
- Reduced time to market: Eliminating the need for complex cleaning (clean-in-place [CIP]/sterilization-in-place [SIP]) results in faster batch turnaround and faster facility setup and facility turnaround.
- Lower CapEx and engineering costs: Minimal modifications to facilities and infrastructure are needed to accommodate SUT.
- Increased flexibility: Easily rearrange equipment to optimize processes or scale new product demands without costly downtime.
However, these benefits come with challenges in standardization, stock keeping unit (SKU) management, and securing the right supplies—challenges that our Batch 360™ service program is designed to address head-on.
Introducing Batch 360™ service: A comprehensive single-use solution for CDMOs
Our Batch 360™ service is designed specifically to provide FlexFactory™ platform solution customers a end-to-end solution for implementing single-use assemblies across biomanufacturing processes. By working through your challenges with our highly experienced and specialized team, CDMOs benefit from a customized and easy-to-navigate process design to achieve a smooth and scalable manufacturing setup, no matter the project complexity.
How the Batch 360™ service works
The design freeze milestone
The Batch 360™ service process begins once the design freeze milestone is reached in a FlexFactory™ platform solution, meaning the equipment and processes are locked in and detailed. For CDMOs, this might involve a platform process that is currently unused, in which case Batch 360™ service can either develop a solution based on the platform or wait until a customer’s process requirements are finalized.
Detailed biomanufacturing process documentation
To identify the most efficient and optimized solution, the Batch 360™ service team works with critical documentation, including:
- Equipment list (EQL)
- Mass balance (MB)
- Process flow diagram (PFD)
- Facility layout
With these inputs, the Batch 360™ service team creates a single-use process flow diagram (SU PFD), to match assemblies and flow kits to each piece of equipment. A bill of materials (BOM) is then generated to streamline the ordering and supply management process.
3D modeling for layout optimization
Using the facility layout, the Batch 360™ service creates a 3D model to visualize equipment adjacencies and optimize tubing runs. This model ensures there is no confusion about the SUT configuration, making it easier for teams to visualize and adjust layouts before implementation.
Fig 1. 3D modeling for layout optimization in our software tool
Biomanufacturing process optimization
A key advantage of Batch 360™ service is its ability to address the common pain points CDMOs face in biomanufacturing, such as standardization, SKU management, and security of supply.
Standardization: The Batch 360™ service team focuses on using standardized assemblies throughout your process, simplifying qualification and procurement and reducing complexity of sourcing.
SKU reduction and streamlining: The Batch 360™ service team helps reduce the number of unique SKUs in your process, simplifying inventory management and incoming inspection. For example, processes using 2000 L mAbs may typically require 350+ SKU items, but Batch 360™ service reduces this by recommending standardized assemblies used in multiple processes.
Fig 2. 3D model of buffer preparation suite in tool which assists in streamlining your processes
Collaborative process walkthrough and optimization
Once the SU PFD and BOM are finalized, the Batch 360™ service team schedules a multi-day collaborative walkthrough with your CDMO team. During this exercise, the team reviews every aspect of your process thoroughly, including:
- Processing techniques
- Processing preferences
- Process requirements
- Opportunities for process optimization
Any changes to the SUT configuration or adjustments to the process are documented and addressed. Finally, the team provides documentation links that the customer can use to qualify their SUT setup.
Flexibility in bioprocess reconfiguration
CDMOs often need flexibility when it comes to reconfiguring their processes to meet specific customer needs, especially when dealing with new therapeutic modalities. While SUT simplifies reconfiguration, it can be difficult to navigate SUT assembly options to find the right fit for you. Batch 360™ service simplifies this process by providing SUT compatibility recommendations and customizing the process flow to match your desired outcome. With expertise in both SUT and various processing techniques, the Batch 360™ service team guides you toward an optimized biomanufacturing process that can help you reach your desired results.
Fig 3. Simplifying SKUs and streamlining process to optimize for success with the Batch 360™ service team
Why choose Batch 360™ service for your success?
Batch 360™ service enables you to:
- Quickly and efficiently implement single-use technology across many biomanufacturing processes.
- Optimize processes for speed, cost efficiency, and flexibility.
- Secure a robust supply chain with standardized solutions.
- Simplify inventory management with optimized SKUs.
The Batch 360™ service program helps drive efficiency while providing flexibility and cost savings in your biomanufacturing operations. Whether you’re implementing new technologies, adapting to customer needs, or optimizing existing processes, Batch 360™ service ensures you have the right tools and expertise to succeed.