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The most critical period for a new facility is often the initial planning phase, before major commitment of capital funds.  Our firm has expertise in basic science, cell culture technology and its scale-up, manufacturing facilities and regulatory requirements.  This range of experience may be helpful in bridging discussions between development scientists and the non-science based professionals required for construction of a manufacturing facility.

We are able to assist emerging biotechnology companies and academic organizations develop a conceptual facility design for their initial pilot or commercial scale manufacturing facility.  This conceptual plan is suitable for presentation to the FDA/CBER and for discussions with the architect/engineering professions that will prepare the detailed design and construction documents.  We have designed 40 manufacturing facilities (30 for cell and gene therapy).

There are a number of tasks that must be accomplished during this initial planning period for the design:

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Definition of the manufacturing process or processes that the facility is planned to support.  A detailed process description document should be prepared.  Is the facility intended to support multiple product manufacture on a campaign or on a simultaneous basis?  Regulatory requirements are different for single product facilities vs. multiproduct facilities.  Will the facility make "patient-specific" products or will single product lots be used for multiple patients?  The scale of manufacturing equipment, number of production rooms, FDA concerns for cross-contamination / product mix-ups and other issues will be different for patient-specific manufacturing.

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One issue that has major regulatory implications is whether viral vaccines or viral vectors will either be used or produced during the manufacturing process.  The FDA has stringent requirements for the handling of live viral substances, which will be a major concern for the facility design.

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Consideration of the scale of manufacturing and type of production technology that will be employed are important facility design criteria.  For initial manufacturing facilities, the technology for and scale of production is often a bridge between the research / pre-clinical levels and the eventual commercial operation.  There are significant regulatory considerations that are important in choosing an appropriate scale of operations and level of technology sophistication.

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Delineation of the maximum capacity for the facility in amount of product and the number of product lots that may be produced annually is also important.  Will the facility be designed for future expansion or for multiple shift operations?  Will the facility only be used for clinical Phases 1 and 2 or will it support Phase 3 and commercial manufacturing?  These decisions have major regulatory implications.

Our firm will develop a facility design which meets both the manufacturing process requirements and the FDA's facility concerns for cGMP/GTP/QSR compliance.  We recommend that this conceptual design be presented to the FDA in a "Type C" facility design meeting with the Division of Manufacturing and Product Quality.

Example room layouts and facility flow diagrams for a pilot gene therapy facility are shown on the WebPages indicated by green buttons at the top of this page.  A larger cell therapy facility is shown below.

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