WO2011066274A1 - Configurations and methods for biopharmaceutical building prototypes - Google Patents

Abstract

Systems and methods of constructing a biopharmaceutical production facility are contemplated that provide a high degree of flexibility for dynamic change throughout the operational lifecycle of the facility. Especially preferred methods utilize specific building prototypes that are optimized for material and personnel traffic patterns and that allow linear expansion of the facility in at least one dimension

Description

CONFIGURATIONS AND METHODS FOR BIOPHARMACEUTICAL BUILDING

PROTOTYPES

[0001] This application claims priority to our U.S. provisional patent application having serial number 61/264208, which was filed 24 November 2009.

Field of The Invention

[0002] The field of the invention is construction, especially as it relates to industry-specific building templates for biopharmaceutical production facilities.

Background of the Invention

[0003] With the increasing size and complexity of biopharmaceutical research and production plants, costs associated with construction, operating conditions, regulatory compliance, and plant life cycle have become paramount. Such challenges are often further compounded by the need for flexibility as process conditions may change, and/or as a result of scale-up of new products. Unfortunately, traditional "low cost" approaches and

engineering solutions that provided "high flexibility" are typically mutually exclusive.

[0004] For example, currently used building configurations, equipment adjacencies, and use of classified clean rooms for specific unit operations have resulted in a standard building model that is now considered unacceptable due to relatively high life cycle cost and the lack of ability to support significant change. On the other hand, where a research and production plant is custom-built to suit specific processes and to allow for at least some flexibility, costs are often very high, if not even unacceptable. Moreover, due to the rapid development of new production technologies, custom-built facility layout for a specific production process is often obsolete within la few years. Additionally, as most owners of such plants are significantly more experienced in their field of endeavor than in the design and construction requirements for research and production plants, lack of effective communication between the plant owner and the builder tends to delay construction and may even result in a plant with less than desirable function.

[0005] To reduce capital investment costs and construction delays, modular design can be employed in which large-scale pre -built production skids are delivered to the production site and then connected to the existing infrastructure (e.g., Plant expansion of DSM Biologies, Montreal Canada). Similarly, in new construction clean rooms can be pre-fabricated to at least some degree (e.g., Dendreon manufacturing plant, New Jersey), however, the advantage of prefabrication typically does not translate to advantages in operational flexibility and easy expansion.

[0006] Thus, there is still a need to provide improved systems and methods for cost-effective yet highly flexible construction of buildings with industry- specific requirements.

Summary of the Invention

[0007] The present invention is directed to systems and methods of building construction, and particularly construction of biopharmaceutical production plants that offer a high degree of flexibility for dynamic change throughout an operational lifecycle of the facility. Systems and methods presented herein will also provide improved material and personnel patterns that can be maintained, even when the facility is expanded or otherwise modified. These and other advantages can be readily and cost-effectively achieved using building prototypes that are then modified to the specific purpose. Such approach not only allows for rapid turnaround at low capital investment, but also accommodates the varying needs for production of particular products. Moreover, the approach presented herein reduces delays due to regulatory approval as compliance requirements are met with validatable design.

[0008] In a preferred aspect of the inventive subject matter, a method of constructing a biopharmaceutical production facility with flexibility for dynamic change throughout an operational lifecycle of the facility includes a step of providing a general circulation corridor. In another step, an operations cluster is provided that comprising at least one general access core and at least one restricted access island, wherein the operations cluster is accessible from the general circulation corridor. In yet another step, a utilities block is configured and placed separate from the operations cluster, and provides utility services to the operations cluster. Most typically, the operations cluster and general circulation corridor form a prototype that is selected from the group consisting of a single core configuration, a double core configuration, a stacked core configuration, and a distributed core configuration. It is still further preferred that the utilities block and the prototype are configured to allow for linear expansion of the prototype in at least one dimension. In still another step, the prototype is then modified to accommodate a plurality of industry-specific processes and/or devices.

[0009] In particularly preferred methods, the general access core and/or the restricted access island are independently accessible from the general circulation corridor. It is still further preferred that the operations cluster and the utilities block are located on opposite sides of the general circulation corridor. While not limiting to the inventive subject matter, it is especially preferred that the prototype is a single core configuration, a double core configuration, a stacked core configuration, or a distributed core configuration.

[0010] Depending on the prototype, linear expansion of the prototype can proceed therefore in at least one dimension, typically by addition of a second prototype of the same kind.

Customization to a particular production plant is then achieved by implementing a clean area, an animal husbandry area, a surgical area, a reactor area, a work-up area, and/or an unrestricted general services area as industry- specific building features. Moreover, it is contemplated that the step of modifying the industry-specific prototype will include a step of populating with and functionally interconnecting the plurality of industry-specific building features with a plurality of devices. For example, the general access core may be equipped with a fermentation reactor, a cell culture reactor, a sterilizer, a centrifuge, and/or a chromatography station, while the restricted access island may be configured as a clean room, a media preparation room, a bio-safety 2+ laboratory, and/or an operating room.

[0011] Various objects, features, aspects and advantages of the present invention will become more apparent from the following detailed description of preferred embodiments of the invention.

Brief Description of the Drawing

[0012] Figure 1 A is a schematic illustration of an exemplary single core prototype of a biopharmaceutical production facility according to the inventive subject matter.

[0013] Figure IB is a model view of the single core prototype of Figure 1A.

[0014] Figure 2A is a schematic illustration of an exemplary double core prototype of a biopharmaceutical production facility according to the inventive subject matter.

[0015] Figure 2B is a model view of the double core prototype of Figure 2A.

[0016] Figure 3 A is a schematic illustration of an exemplary stacked core prototype of a biopharmaceutical production facility according to the inventive subject matter.

[0017] Figure 3B is a model view of the stacked core prototype of Figure 3 A. [0018] Figure 4 A is a schematic illustration of an exemplary distributed core prototype of a biopharmaceutical production facility according to the inventive subject matter.

[0019] Figure 4B is a model view of the distributed core prototype of Figure 4A.

[0020] Figure 5A is a schematic illustration of an exemplary single use core prototype of a biopharmaceutical production facility according to the inventive subject matter.

[0021] Figure 5B is a model view of the single use core prototype of Figure 5 A.

[0022] Figures 5C and 5D depict exemplary product and material flow in the single use core prototype of Figure 5 A.

Detailed Description

[0023] The present invention is directed to configurations and methods of highly adaptable building prototypes that are based on value-added design features. Contemplated prototypes can be rapidly adapted to a biopharmaceutical manufacturer's specific program and provide the ability to control building cost and schedule while affording the building owner increased flexibility. Upon delivery of a mature manufacturing process and technical specifics, building prototypes according to the inventive subject matter can be used to rapidly produce an optimized design solution based on a set of design features and implementation activities.

[0024] Among other benefits of using such building prototypes, it should be appreciated that custom built facilities, or the need and associated cost of investigating alternate geometries, materials, and implementation schemes is eliminated, even where highly specific and/or changing production parameters are encountered. Viewed from a different perspective, use of the building prototypes will allow to deliver an optimized solution which is not predicated by a specific process and technology, but based on heretofore not identified prototypes that are optimized for material and traffic patterns, engineering flexibility, reduced capital requirements, and regulatory compliance.

[0025] Remarkably, the prototypes and associated systems and methods presented herein can readily accommodate the specific needs for numerous and/or distinct biopharmaceutical production processes, even where the parameters for the processes change during the building or production phase. Thus, contemplated methods allow for the construction of a low-cost biopharmaceutical production plant that is flexible and adaptable to accommodate product development timelines and product changeovers without incurring high investment cost or compromising established regulatory posture. As such methods also significantly facilitate standardization, design development is accelerated, leading to predictable implementation schedules and highly accurate cost estimates.

[0026] In one especially preferred aspect of the inventive subject matter, a biopharmaceutical production facility is constructed from and based on a prototype that is then further modified to accommodate a plurality of industry-specific processes or devices. Particularly preferred prototypes will provide an advantageous building geometry (in terms of constructability, internal height, materials of construction, equipment access and maintainability, mechanical adjacency relationships and designations as to air classification) to so accommodate the particular needs or requirements for the facility. Whereas in the past, much energy and effort has gone into the definition of these parameters and the achievement of a suitable building geometry or three dimensional solution, the a priori endorsement of a prototype considerably accelerates the decision making and concentrates the engineering effort in working out the specific technical challenges of the individual product to be manufactured. Most typically, the facility will be completed using currently known modular wall and ceiling systems as well as modular skid stations for the components involved in the production.

[0027] The inventors have now discovered that despite the substantially different regulatory requirements and process idiosyncrasies, most, if not all biopharmaceutical production facilities can be built on the basis of one or more of four distinct prototypes: a single core configuration, a double core configuration, a stacked core configuration, and a distributed core configuration. In most typical aspects, the prototype is formed by an operations cluster and a general circulation corridor, wherein the operations cluster includes at least one general access core and at least one restricted access island. It is still further preferred that the restricted access island is enclosed by a system of walls and ceilings to so form a physically isolated structure (that also typically receives individual air supply). Similarly, the general access core is preferably enclosed by a plurality of walls to so allow at least partial isolation. However, it should be noted that the general access core may also be defined by open space (within the confines of a building) in which the restricted access islands may be disposed. As used herein, the term "general access" in conjunction with an area or building means that the area or building can be entered by a person without physical restriction {e.g., code-locked or biometric-locked door, etc.) and/or pre-authorization. In contrast, as also used herein, the term "restricted access" in conjunction with an area or building means that entrance by a person to the area or building is permitted only upon meeting one or more conditions. Most typically, restricted access will also include use of a physical restriction (e.g., code-locked or biometric-locked door, etc.) and/or pre-authorization.

[0028] For example, Figure 1A depicts a single core prototype 100A in which an operations cluster is formed from a general access core 110A and a plurality of restricted access islands 120A/120A'. Most typically, restricted access island 120 A' is configured as a preparatory area (e.g., for change of clothes or other protective gear, for material storage or media preparation, or for clean room utilities) that is physically separate from restricted access island 120 A that is typically configured as restricted processing area (e.g., as clean room, cold room, operating room, cell culture room, biosafety laboratory, etc.). It is further generally preferred that the restricted access island 120 A has a direct and controlled connection to the general access core 110A, typically via a door, a transfer window, or controlled exit path (e.g., exit air lock). Of course, it should be noted that the restricted access islands 120A/120A' need not be of the same type, but may vary in function and/or size. Likewise, the number of restricted access islands 120A/120A' may vary considerably and the exact number will be determined on the process and regulatory requirements for the production facility.

[0029] In the example of Figure 1A, it should be noted that access and traffic of material and personnel is limited/controlled to specific pathways. Here, general circulation corridor 140A provides general access to and from the operations cluster. More specifically, general access core 110A interfaces with general circulation corridor 140 A (typically via doors or opening in a wall) to provide unrestricted access to the core 110A. Also, separately accessible from the general circulation corridor 140 A via restricted access points 144 A is the restricted access pathway 146 A that allows access to at least one, and more preferably all of the restricted access islands. Thus, by routing restricted access traffic peripherally, the flow of personnel traffic follows the required functions. Material flow is typically routed though the general access core 110A for unrestricted materials, while materials for the restricted access islands is provided via controlled material access points 142 A.

[0030] Utility services are provided from utilities block 130A, typically through overhead racks and pipes to both the general access core 110 and restricted access islands 120A/120 . Where desired, restricted access islands 120A/120 may receive separate utility service from units located at the restricted access islands (e.g. , steam generator for sterilization, deionized and/or highly purified water, etc.), and will typically have a separately controlled air supply (which may also be independent from the main air supply). Consequently, controlled access space and length of material flow from and to the controlled access space can be significantly reduced, which in turn reduces capital cost and improves operational flow.

[0031] Therefore, it should be appreciated that a single core prototype will provide a compact arrangement of production space in which material and personnel flow is controlled and in which space requirements are minimized by strategically interfacing restricted and non restricted production areas. Moreover, it should be noted that the single core configuration allows for traffic through all areas while providing a restricted personnel traffic pattern with unidirectional material flow (materials flow in one direction from less processed to more processed). Still further, as most support functions are peripheral and delivered to operations cluster/core and islands from a physically separate utilities block, expansion can take place in desired increments without the need to reconfigure the services and/or operations cluster. It is further generally preferred that support facilities (e.g., lockers, toilets, warehouse, dispensary, waste collection, etc.) are located outside of the single core prototype. Most preferably, the support facilities are accessible from the general access corridor and are located next to the operations cluster.

[0032] In further preferred aspects, general access core 11 OA is separated from the restricted areas (e.g., islands and restricted pathways) by walls or other confinement structures, while being open or accessible on at least one side for delivery of equipment (e.g., accessible for skid delivery by truck or forklift). Thus, the general access core may include a loading dock or in less preferred aspects an overhead rail and crane. Restricted access islands 120A/120A' will preferably be configured as separate modules that may or may not be prefabricated. In especially preferred aspects, the modules are independently supplied with all or most of the utility requirements from the utilities block via overhead trays and racks to so allow for simple addition or removal of specified work space. Typically, the general access core and restricted access islands will be housed in a building having a unitary ceiling. Where needed a high bay story or utility penthouse may be included.

[0033] Therefore, the term "single core" as used herein refers to a building prototype in which a single general access core is located between at least two restricted access islands, wherein a restricted access pathway peripherally surrounds the single general access core and the restricted access islands such that the restricted access islands (and optionally also the single general access core) are only accessible from the restricted access pathway, wherein the general access core is accessible from a general circulation corridor (and optionally the restricted access pathway), and wherein the general circulation corridor allows for controlled access to the restricted access pathway.

[0034] Figure IB shows an exemplary single core model view in which a general circulation corridor access provides general access to general access core HOB. Restricted access islands 120B/120B' have different configurations in this example and are all accessible from the peripheral restricted access pathway 146B via restricted access points 144B. Material is delivered to the restricted access islands 120B/120B' via controlled material access points 142B. Utility services are provided from the utility block via overhead tracks and trays 15 OB to the general access core HOB and restricted access islands 120B/120B'. Non-critical support functions are provided by peripheral building (or trailer) 160B. As shown by the arrow, the operational cluster/prototype can be easily expanded by adding further general access core and/or restricted access islands, to which utilities and access pathways are provided in the same manner as to the existing structure without need for relocating structural or functional components. Viewed from a different perspective, contemplated system allow for a plug-and-play system that can be easily modified and/or expanded.

[0035] In another example, a double core prototype is schematically illustrated in Figure 2A. Here, double core prototype 200A comprises two separate general access cores 21 OA that are accessible from the general circulation corridor 240A. Each of the general access cores 21 OA is also separately accessible via the corresponding restricted access islands 220A/220A, thereby again ensuring unidirectional material flow. General circulation corridor 240A also provides access points 244 to the restricted access pathway 246. Once more, the restricted access pathway 246A allows access to at least one, and most preferably all of the restricted access islands, from which the respective general access cores can be reached via respective doors or other controlled connections. Similarly, materials can be delivered through controlled material access points 242 from the general circulation corridor to the restricted access islands. As in the example of the single core of Figure 1A above, utility services are typically provided from utility block 230A via overhead tracks and trays.

[0036] Thus, it should be appreciated that using a double core prototype, a production facility can be constructed that allows for two separate and distinct and even incompatible production processes, each of which may have its own regulatory and process requirements, while at the same time minimizing restricted personnel traffic pattern and maintaining unidirectional material flow. Moreover, and as illustrated in Figure 2B below, the double core prototype can be easily expanded without the need for relocating structural or functional components. It is further preferred that all primary piping and other services from the utility block are concentrated in/over the general access core to so enable linear expandability in two or three directions. Support functions are peripheral and delivered to operations cluster/core and islands. Thus, it is generally preferred that the utility services are typically provided through overhead utility rack that is routed over core, then distributed to islands. HVAC system for restricted islands is preferably (but not necessarily) segregated. The non-clean air handling may then be suitable for placement on one side of the prototype or roof. With respect to similar structures and functions in Figures 1 A and 2 A, the same considerations for Figure 1 A above apply in Figure 2A.

[0037] Therefore, the term "double core" as used herein refers to a building prototype in at least two restricted access islands are located between two separate and distinct general access cores, wherein a bidirectional restricted access pathway between the restricted access islands and the general access cores such that the restricted access islands (and optionally also the single general access core) are only accessible from the restricted access pathway, wherein the general access cores are accessible from a general circulation corridor (and optionally the restricted access pathway), and wherein the general circulation corridor allows for controlled access to the restricted access pathway.

[0038] Figure 2B is an exemplary model view of a double core prototype in which a general circulation corridor access provides general access to both general access cores 210B. As before, restricted access islands 220B/220B' have different configurations in this example and are all accessible from the central restricted access pathway via restricted access points 244B. Material is delivered to the restricted access islands 220B/220B' via controlled material access points 242B. Utility services are provided from the utility block via the bifurcated overhead tracks and trays 250B to the general access cores and restricted access islands. Further non-critical support functions are provided by peripheral building (or trailer) 260B. As shown by the arrow, the operational cluster/prototype can be easily expanded by adding further general access core and/or restricted access islands, to which utilities and access pathways are provided in the same manner as to the existing structure without need for relocating structural or functional components. Once more it should be noted that the systems presented herein allow for a plug-and-play architecture that can be easily modified and/or expanded.

[0039] In yet another example, Figure 3A depicts a stacked core prototype 300A in which two separate general access cores 310A are accessible from two general circulation corridor 340A, wherein one of the cores and corridors are located above another of the cores and corridors as can be more clearly seen from Figure 3B. Each of the general access cores 310A is separately accessible via corresponding restricted access islands 320A/320A, thereby again ensuring unidirectional material flow. General circulation corridor 340A also provides access points 344 to the restricted access pathway 346. As before, restricted access pathway 346A allows access to at least one, and most preferably all of the restricted access islands, from which the respective general access cores can be reached via respective doors or other controlled connections. Materials can be delivered through controlled material access points 242 from the general circulation corridor to the restricted access islands. Additionally, vertical material transfer point 343A allows for material exchange between the separate levels. Similar to the example of the single core of Figure 1A above, utility services are typically provided from utility block 330A via overhead tracks and trays.

[0040] Thus, it should be appreciated that using a stacked core prototype, a production facility can be constructed that allows for two separate and distinct and even incompatible production processes, each of which may have its own regulatory and process requirements, while at the same time minimizing plot space for the facility. As before, it should be noted that the restricted personnel traffic pattern is limited and unidirectional material flow is enabled. In some cases, gravity flow may be used to transfer material from an upper to a lower level. As can be taken from Figure 3B below, the stacked core prototype can be easily expanded in two dimensions without the need for relocating structural or functional components. Once more, all primary piping and other services from the utility block are concentrated in/over the general access core to so enable linear expandability in two or three directions. Support functions are peripheral and delivered to operations cluster/core and islands. With respect to similar structures and functions in Figures 1 A/2A and 3A, the same considerations for Figure 1 A/2A above apply in Figure 3A.

[0041] Therefore, the term "stacked core" as used herein refers to a building prototype in which a single general access core is adjacent to at least one restricted access island, wherein a restricted access pathway surrounds the restricted access island on at least two sides such that the restricted access island (and optionally also the single general access core) is only accessible from the restricted access pathway, wherein the general access core is accessible from a general circulation corridor (and optionally the restricted access pathway), and wherein the general circulation corridor allows for controlled access to the restricted access pathway.

[0042] Figure 3B depicts a stacked core has a first and second floor (as shown in the left and right panel, respectively). As is readily apparent, the operations clusters are now vertically distributed and accessible via stacked general access corridors. Of course, additional material and/or personnel pathways may be provided at the outside of the clusters, which may or may not obviate the general access corridor.

[0043] In a still further example, as shown in Figure 4A, a distributed core prototype 400A is illustrated. Here, a general circulation corridor 440A provides access to each of the individual operations clusters, which are physically separated from each other. Each of the operations clusters comprises a cores 41 OA, which is typically not generally accessible from the corridor 440A. However, it should be noted that the core 41 OA may be of general access nature from the outside or via a pathway that is connected to the general circulation corridor 440A (typically bypassing the restricted access islands 420A/420A. As should be readily apparent, restricted access islands 420A/420A' may have different configurations and are all accessible from the general circulation corridor 440A via restricted access points 444A.

Material is delivered to the restricted access islands 420A/420A' via controlled material access points 442A. As before, utility services are provided to the individual operations clusters from the utility block 430A via the distributed overhead tracks and trays. With respect to similar structures and functions in Figures 1 A/2 A/3 A and 4 A, the same

considerations for Figure 1 A/2 A/3 A above apply in Figure 4 A.

[0044] Therefore, the term "distributed core" as used herein refers to a building prototype in which a plurality of restricted access islands are located between respective general access cores and a general circulation corridor such that the restricted access islands and the general access cores are only accessible from the a general circulation corridor.

[0045] Figure 4B depicts an exemplary model view of a distributed core prototype facility in which multiple operations clusters are associated with a single general circulation corridor and in which support functions are peripheral and delivered from the utilities block to the individual operations cluster/core and islands. As can be taken from this figure, distributed core prototypes are relatively space consuming. However, distributed core prototypes afford unique advantages over other prototypes in that they allow for isolated classified traffic in each operations cluster. Thus, each cluster can be highly specialized and adapted. Moreover, the facilities with distributed cores can be readily and incrementally expanded by adding additional operations clusters.

[0046] In yet another example, as shown in Figure 5A, a single use core prototype 500A is illustrated. Here, a peripheral general circulation corridor 540A provides access to two distinct general access cores 51 OA, and optionally access to the at least one restricted access islands 520A/520A'. Controlled material access points 542A allow delivery of materials to the operations clusters, and more typically to at least one of the restricted access islands 520A/520A. Restricted access islands 520A/520A are also accessible from restricted access pathway 546A via restricted access points 544A. Most preferably, the restricted access pathway 546A is located between two clusters of restricted access islands 520A/520A and two distinct general access cores 51 OA. Thus, material flow and personnel flow is once more controlled. As before, utility services are provided to the operations clusters from the utility block 530A via the distributed overhead tracks and trays. With respect to similar structures and functions in Figures 1 A/2 A/3 A/4 A, the same considerations for Figure 1 A/2 A/3 A/4 A above apply in Figure 5A.

[0047] Therefore, the term "single use core" as used herein refers to a building prototype in which a two general access cores are located between at least two restricted access islands, respectively, wherein a bidirectional restricted access pathway is located between the general access cores and respective restricted access islands such that the restricted access islands (and optionally also the single general access core) are only accessible from the restricted access pathway, wherein the general access core is accessible from a general circulation corridor (and optionally the restricted access pathway), and wherein the general circulation corridor allows for controlled access to the restricted access pathway.

[0048] Figure 5B depicts an exemplary model view of a single use core prototype facility in which multiple restricted access islands are associated with a peripheral general circulation corridor and a restricted access pathway. Here, the general access cores are located on either side of the restricted access pathway and are further disposed between restricted access islands on either side. Consequently, it should be noted that this prototype is particularly advantageous where the production process involves upstream and downstream process steps that should be separated. Figure 5C depicts an exemplary material flow in a facility according to Figure 5A. Here, material flow is depicted as wide arrow and the operations are indicated in the respective areas. Figure 5D exemplarily depicts the flow of used equipment and waste materials leaving the restricted access islands and general access core via the peripheral general access corridors, while clean equipment, consumables, and product intermediates move bidirectionally through the restricted access pathway.

[0049] Therefore, it should be appreciated that by assembling value-added technical solutions from all disciplines into an organized prototype, the building prototype can leverage proven cost saving designs and methods, as well as satisfy the need for flexibility. Each prototype also exhibits individual spatial relationships and approaches to CGMP compliance. Viewed from a different perspective, it should be noted that contemplated prototypes will provide a three dimensional framework for organizing and implementing an FDA compliant manufacturing process, while taking advantage of optimized mechanical adjacencies, personnel and materials flow patterns and the ability to expand or contract in the future with minimal impact to ongoing operations.

[0050] Of course, it should also be appreciated that the prototypes as presented herein are not limited to biotechnological research and production facilities, but also have broad application across many technology based industries since a set of optimized prototypes can be developed in alternative fields of endeavor. Thus, any technical organization looking to build a "Low Cost" manufacturing facility with a high level of flexibility will be able to take advantage of the configurations and methods presented herein.

[0051] Thus, specific embodiments and methods of biopharmaceutical building prototypes have been disclosed. It should be apparent, however, to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims.

Claims

CLAIMS What is claimed is:

1. A method of constructing a biopharmaceutical production facility with flexibility for dynamic change throughout an operational lifecycle of the facility, comprising:

providing a general circulation corridor;

providing an operations cluster comprising at least one general access core and at least one restricted access island, wherein the operations cluster is accessible from the general circulation corridor;

configuring and placing a utilities block separate from the operations cluster, wherein the utilities block is configured to provide utility services to the operations cluster;

wherein the operations cluster and general circulation corridor form a prototype that is selected from the group consisting of a single core configuration, a double core configuration, a stacked core configuration, a single use core configuration, and a distributed core configuration; and

wherein the utilities block and the prototype are configured to allow for linear

expansion of the prototype in at least one dimension;

modifying the prototype to accommodate a plurality of at least one of an industry- specific process and an industry-specific device.

2. The method of claim 1 wherein the at least one general access core and the at least one restricted access island are independently accessible from the general circulation corridor.

3. The method of claim 1 wherein the at least one restricted access island is accessible from the general circulation corridor.

4. The method of claim 1 wherein the operations cluster and the utilities block are

located on opposite sides of the general circulation corridor.

5. The method of claim 1 wherein the prototype is a single core configuration.

6. The method of claim 1 wherein the prototype is a double core configuration.

7. The method of claim 1 wherein the prototype is a stacked core configuration.

8. The method of claim 1 wherein the prototype is a single use core configuration.

9. The method of claim 1 wherein the prototype is a distributed core configuration.

10. The method of claim 1 wherein the linear expansion of the prototype in at least one dimension comprises addition of a second prototype of the same kind.

11. The method of claim 1 wherein industry-specific building features are selected from the group consisting of a clean area, an animal husbandry area, a surgical area, a reactor area, a work-up area, and an unrestricted general services area.

12. The method of claim 1 wherein the step of modifying the industry- specific prototype comprises populating with and functionally interconnecting the plurality of industry- specific building features with a plurality of devices.

13. The method of claim 1 wherein the at least one general access core comprises at least one of a fermentation reactor, a cell culture reactor, a sterilizer, a centrifuge, and a chromatography station.

14. The method of claim 1 wherein the at least one restricted access island comprises a clean room, a media preparation room, a bio-safety 2+ laboratory, and an operating room.