Integration of a Single-Use Platform Process within an Innovative Facility Design - The combination of single-use platform technology with modular facility construction is a template for flexible manu

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Integration of a Single-Use Platform Process within an Innovative Facility Design
The combination of single-use platform technology with modular facility construction is a template for flexible manufacturing.


BioPharm International Supplements
Volume 25, Issue 11, pp. s27-s32

A PROPOSED MONOCLONAL ANTIBODY FACILITY CONCEPT


Figure 3: A monoclonal antibody facility equipped with Sartorius’ Process4Success single-use process platform technology.
With the palette of features designed into the pods, innovative facility designs can be realized to address most pharmaceutical process challenges. Figure 3 illustrates the application of such technology to a typical mAb facility equipped with Sartorius' Process4Success single-use process platform technologies. The facility combines the use of gray space to house and service the classified area and more traditional "stick-built" areas to serve as support space.

This arrangement features a "ballroom" type approach to pod topology developed in a 32,000-ft2 class A warehouse-type structure. The upstream pod houses two BIOSTAT CultiBag STR single-use bioreactors and support equipment such as a biosafety cabinet, incubator shaker, BIOSTAT CultiBag RM seed reactor, and FlexAct CH system for primary clarification and filtration. Buffers and media are produced in conventional rooms on the south side of the plan using Palletank and Flexel Bags for mixing and storage and then transferred via a controlled nonclassified (CDC) corridor to the primary materials air lock (MAL) that services the Class D working area within the cGMP envelope.

Once the cells are expanded and production of the mAb is accomplished in the 500-L bioreactor, the cell mass is filtered out and transferred between pods using the Biosafe Rapid Aseptic Fluid Transfer System (RAFT). The downstream pod is equipped with a typical three-stage capture and chromatography system for mAb purification as well as the required virus clearance steps performed with the FlexAct VI and VR systems.

This particular design serves the purpose of also integrating a syringe filling operation as part of the process integration. Two pods are joined together to provide a space for a modular sterile syringe fill system. The Class D corridors serve as personnel air locks (PAL) and MALs for moving large amounts of packaging and filled materials into and out of the Class B workspace surrounding a Class A cabinet based fill system. An inspection and packaging pod is the final step in the cGMP envelope before transferring the product to shipping.

ADVANTAGES

A cost analysis was made by an outside engineering firm to compare hard costs between the pod-based design and an equivalent stick-built or modular hardwall cleanroom system. The cost savings on the total project was found to be greater than 30% for the pod-based design. The largest savings were in HVAC costs, utilities distribution costs, and superstructure costs.

Because the facility can be built in a generic building using pod technology, developers will consider financing the construction of the shell using a lease-back financing model that relieves some of the capital burden. Costs savings on engineering, construction supervision, and savings in QA costs by employing premanufactured autonomous cleanrooms are not reflected in the capital expenditure savings.

The opportunity cost is greatly enhanced because the process portion of the build is being completed in parallel, not iteratively, to the shell and support space. This should in most cases deliver a functioning facility to the user in less than 18 months.


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