This application claims the benefit of priority to U.S. Provisional Patent
Application Serial No. 62/306,556 filed on March 10, 2016, which is hereby incorporated herein by reference in its entirety for all purposes.

FIELD OF THE INVENTION

[0002] The present disclosure relates to a customizable facility that enables a user to manufacture multiple products within the facility. In particular, the present disclosure relates to a customizable facility for manufacturing products in clean room settings.

BACKGROUND

[0003] Traditional structures for manufacturing products, such as monoclonal antibodies and microbial products, do not allow for efficient use of the space of the structure. The layout of traditional structures often limits them from being readily configured or expanded to

manufacture a new product line. Thus, there is a need for a manufacturing facility that allows a user to efficiently use common resources between product lines and readily modify the facility to accommodate a new manufacturing process or a new manufacturing line with reduced facility down time.

SUMMARY

[0004] The present disclosure provides a customizable facility for manufacturing at least one product, utilizing at least one production process (e.g., a production process using a

fermentation unit and a purification unit). According to one aspect of the present disclosure, the customizable facility includes a shell, at least one central unit positioned within the shell, and at least one modular unit, each modular unit being positioned within the shell. The shell, the central unit(s), and the modular unit(s) are configured and arranged to maximize the speed and ease of modifying manufacturing capacity of varying scope.

[0005] According to another aspect of the present disclosure, a customizable facility for manufacturing at least one pharmaceutical product, includes at least one central unit. At least one modular unit is in communication with the at least one central unit such that the at least one central unit provides utilities to the at least one modular unit.

[0006] In some embodiments, the customizable facility includes a shell, wherein the at least one central unit is positioned at least partially within the shell and the at least one modular unit is positioned at least partially within the shell.

[0007] In some embodiments, the at least one modular unit includes at least one of a fermentation unit, a pre-viral unit, a post-viral unit, a utility space, a warehouse, a media buffer facility, an office, a personnel unit, a production unit, a fill-finish unit, a dosage formulation unit, and a packaging unit.

[0008] In some embodiments, at least one of the at least one modular unit is directly adjacent to the at least one central unit.

[0009] In some embodiments, the at least one modular unit includes a plurality of modular units arranged to maximize a number of modular units within the shell while

minimizing a footprint of the shell.

[0010] In some embodiments, each modular unit of the plurality of modular units is directly adjacent at least one of the at least one central unit and another one of the plurality of modular units.

[0011] In some embodiments, the at least one central unit and the plurality of modular units form a hub and spoke formation.

[0012] In some embodiments, the at least one central unit and the plurality of modular units are arranged in an H-shaped layout.

[0013] In some embodiments, the customizable facility includes a bioreactor supported on a ground surface within the shell.

[0014] In some embodiments, the customizable facility includes a bioreactor supported within one of the at least one modular unit.

[0015] In some embodiments, an outer wall of the customizable facility is one of: formed by the shell, the shell entirely enclosing the at least one central unit and the at least one modular unit; and formed by the shell and at least one of an outer wall of the at least one central unit and an outer wall of the at least one modular unit.

[0016] In some embodiments, the shell includes at least one side wall, the at least one side wall encircling the at least one central unit and the at least one modular unit, and a roof secured to an upper edge of the at least one side wall, the roof extending over the at least one central unit and the at least one modular unit.

[0017] In some embodiments, at least one of the at least one modular unit is a clean room.

[0018] In some embodiments, the at least one modular unit is configured for cell therapy operations.

[0019] According to another aspect of the present disclosure, a method of assembling a facility for manufacturing at least one pharmaceutical product includes providing at least one central unit; and providing at least one modular unit in communication with the at least one central unit such that the at least one central unit provides utilities to the at least one modular unit.

[0020] In some embodiments, the method includes providing a shell; positioning the at least one central unit at least partially within the shell; and positioning the at least one modular unit at least partially within the shell.

[0021] In some embodiments, the at least one modular unit includes at least one of a fermentation unit, a pre-viral unit, a post-viral unit, a utility space, a warehouse, a media buffer facility, an office, a personnel unit, a production unit, a fill-finish unit, a dosage formulation unit, and a packaging unit.

[0022] In some embodiments, the at least one modular unit includes a plurality of modular units arranged to maximize a number of modular units within the shell while

minimizing a footprint of the shell.

[0023] In some embodiments, each modular unit of the plurality of modular units is directly adjacent at least one of the at least one central unit and another one of the at least one modular unit.

[0024] In some embodiments, the at least one central unit and the plurality of modular units form a hub and spoke formation.

[0025] In some embodiments, the at least one central unit and the plurality of modular units are arranged in an H-shaped layout.

[0026] In some embodiments, the method includes one of supporting a bioreactor on a ground surface within the shell and supporting a bioreactor within one of the at least one modular unit.

[0027] In some embodiments, an outer wall of the customizable facility is one of: formed by the shell, the shell entirely enclosing the at least one central unit and the at least one modular unit; and formed by the shell and at least one of an outer wall of the at least one central unit and an outer wall of the at least one modular unit.

[0028] In some embodiments, the shell includes at least one side wall, the at least one side wall encircling the at least one central unit and the at least one modular unit, and a roof secured to an upper edge of the at least one side wall, the roof extending over the at least one central unit and the at least one modular unit.

[0029] In some embodiments, the at least one pharmaceutical product is a biosimilar product.

DESCRIPTION OF THE FIGURES

[0030] The accompanying drawings are not intended to be drawn to scale. For purposes of clarity, not every component may be labeled in every drawing. In the drawings:

[0031] FIG. 1 is a top view of an embodiment of a customizable facility according to the present disclosure;

[0032] FIG. 2A is a perspective view of the embodiment of FIG. 1;

[0033] FIG. 2B is a perspective view of the embodiment of FIG. 1, showing a location of a component within the customizable facility;

[0034] FIG. 2C is a perspective view of the embodiment of FIG. 1, showing a location of another component within the customizable facility;

[0035] FIG. 2D is a perspective view of the embodiment of FIG. 1, showing a location of another component within the customizable facility;

[0036] FIG. 2E is a perspective view of the embodiment of FIG. 1, showing a location of another component within the customizable facility;

[0037] FIG. 3A is an exploded view of an embodiment of a modular unit according to the present disclosure;

[0038] FIG. 3B is an exploded view of another embodiment of a modular unit according to the present disclosure;

[0039] FIG. 3C is an exploded view of another embodiment of a modular unit according to the present disclosure;

[0040] FIG. 3D is an exploded view of another embodiment of a modular unit according to the present disclosure;

[0041] FIG. 3E is an exploded view of another embodiment of a modular unit according to the present disclosure;

[0042] FIG. 4 is a front perspective cutaway view of an embodiment of a customizable facility according to the present disclosure;

[0043] FIG. 5 is a perspective view of a set of modular units and a central unit arranged in an H-shaped layout;

[0044] FIG. 6 is a top view of a set of modular units and a central unit arranged in an H-shaped layout;

[0045] FIG. 7 is a perspective view thereof;

[0046] FIG. 8 is a top view of modular units and central units arranged in another arrangement within a shell;

[0047] FIG. 9 is a top view of another arrangement of modular units and central units arranged within a shell;

[0048] FIG. 10 is a top view of another arrangement of modular units and central units; and

[0049] FIG. 11 is a schematic view of a set of modular units and a central unit arranged in a spine.

DETAILED DESCRIPTION

[0050] The structures disclosed herein for a customizable facility are useful for manufacturing at least one product at a given time. The structures disclosed herein are particularly useful for manufacturing a variety of products that utilize common resources.

[0051] The present disclosure provides systems and methods that allow for one or more scalable product lines to be at least partially enclosed within a shell of a customizable facility. Because the structure is adaptable, it does not require a user to commit the structure to a single product line for a long period of time. The structure can be reconfigured to meet the dimensional requirements of a product line.

[0052] The customizable facility of the present disclosure enables a user to decrease construction timelines, reduce capital expenditures, increase global design standardization, and to comply with various standards around the globe.

[0053] The customizable structure allows for shorter turnaround times from conception to construction, allows for decreased construction site congestion and requires fewer fixed assets when implementing a new product line.

[0054] Generally, the customizable facility comprises a shell, at least one central unit positioned within the shell, and at least one modular unit, each modular unit being positioned within the shell.

[0055] FIG. 1 is a top plan view of an exemplary embodiment of a customizable facility generally indicated at 10. The customizable facility of FIG. 1 can be constructed in a series of phases, such as a first phase 12, a second phase 14, and subsequent phases.

[0056] The features installed in the first phase 12 of construction of the customizable facility 10 of FIG. 1 include an air controlled entryway 16, a changing area 18, a utilities area 20, a first manufacturing wing 22A, a first office space 24A, and at least one corridor 28 allowing occupants of the customizable facility 10 to move within the customizable facility 10 from one area to another.

[0057] Outside of the customizable facility 10, there is a yard 30 that includes a handling area 32 for handling equipment and materials. The yard area 30 is shown adjacent to a roadway 34. Generally, the customizable facility 10 can be expanded in any direction. Additionally, the customizable facility 10 is constructed such that it can expand in a series of construction phases and/or sub-phases within the physical constraints of the surrounding features, such as the yard area 30 and the roadway 34.

[0058] FIG. 1 shows additional features that can be added during a second phase 14 of construction, such as a second manufacturing wing 22B and a second office space 24B.

[0059] The layout of the customizable facility 10 can be configured for manufacturing in clean room settings. The customizable facility 10 utilizes a hybrid stick or frame build building and modular buildings with a utilities unit (or utility hub).

[0060] Referring now to FIGS. 2A-2E, the relative positions of various components of the customizable facility are shown.

[0061] FIG. 2A shows a perspective view of the exterior walls of the outer shell 36 of the customizable facility 10. The outer shell (or shell) 36 at least partially encloses a central unit (which may be a central utilities unit) 38 and at least partially encloses a plurality of modular units 40, as discussed further below. In some embodiments, the outer shell 36 entirely encloses the utilities unit (which may be a central utilities unit) 38 and entirely encloses the plurality of modular units 40.

[0062] The outer shell 36 can be constructed according to traditional stick building or another method, such as, but not limited to, prefabricated modules. For example, the outer shell 36 can be fabricated from a steel structure using traditional building methods. The outer shell 36 can be supported on footings secured in the ground. The outer shell 36 is weatherproof.

[0063] The outer shell 36 forms a superstructure. In some embodiments, the outer shell

36 can be a "Butler" style building, which is known in the art of building construction.

[0064] The outer shell 36 includes side walls 42 that are dimensioned and configured to encircle one or more central units 38 and one or more modular units 40 included in the customizable facility 10, and described in more detail below.

[0065] A roof 44 is secured to upper edges of the side walls 42, with the roof 44 extending over the central unit(s) 38 and the modular unit(s) 40. Thus, the side walls 42 and the roof 44 enclose the central unit(s) 38 and the modular unit(s) 40, which are positioned within the shell 36. The central unit(s) 38 and the modular unit(s) 40 may be supported on a floor of the shell 36 or on another support surface on which the shell is secured. The customizable facility 10 provides a partially-modular (what could be called a modular stick build) method that includes a basic superstructure that is then filled in with modular type elements.

[0066] In one embodiment, the customizable facility 10 of FIG. 2A has an outer height of

30 meters. In one embodiment, each manufacturing wing has a length of 100 meters and a width of 30 meters.

[0067] FIG. 2B shows the exterior of the customizable facility 10 in broken lines, with the utilities area in solid lines. The utilities area 20 can include a central unit (which may be referred to as a Central Utility Bay (CUB) or utilities building or central utility module) 38 that is positioned towards the middle of the customizable facility 10.

[0068] The shell 36 of FIG. 1 also encloses a future utilities area 46, which is fully occupied by a future utilities module in FIG. 1. The future utilities area 46 is adjacent to the utilities module 38, and is shown in FIG. 1. The future utilities area 46 can be used as a warehouse area adjacent to the utilities module 38. The future utilities area 46 within this customizable facility 10 could also suite high bay applications, such as a 40 foot tall warehouse having an automated search and retrieval system (ASARS).

[0069] In some embodiments, the utilities module 38 and the future utilities area 46 are a single utilities module, which is divided into a utilities section and a future utilities section.

[0070] The central utility module 38 does not need to be at the center of the customizable facility 10. The central utility module 38 can be positioned along an outer edge of the customizable facility 10 in some embodiments.

[0071] FIG. 2C shows the exterior of the customizable facility 10 in broken lines, with the manufacturing wings 22A, 22B in solid lines.

[0072] The manufacturing wings 22A, 22B are configured to contain modular units 40 for a product line, such as fermentation modules or purification modules. The customizable facility 10 is easily expandable and scalable, and the different modular units 40 within the manufacturing wings 22A, 22B can be used to produce completely different products in the same customizable facility 10.

[0073] For example, in a modular unit 40 configured as a first fermentation module, a user could be manufacturing one type of product, such as a monoclonal antibody product derived from a mammalian cell line. In a second modular unit 40, the user could manufacture a completely different product, such as a microbial product. The customizable facility 10 of the present disclosure is capable of supporting multiple product lines simultaneously and multiple customers from a single, expandable superstructure. The customizable facility 10 of the present disclosure is capable of being expanded to add additional product lines.

[0074] Reactors can be supported within the modular units 40 of the manufacturing wings 22A, 22B of the customizable facility 10. The customizable facility 10 can support any desired and suitable vessel volume. For example, in some aspects such as that shown in FIG. 1, the customizable facility 10 can be configured to contain up to 20,000 liter production vessels, and storage vessels (e.g., harvest) in excess of 20,000 liters (e.g., 23,000 - 24,000 liters). For example, the customizable facility 10 can be dimensioned and configured to support vessels having a volume of about 20,000 liters, 15,000 liters, 10,000 liters, 5,000 liters, 2,000 liters and/or 1,000 liters. Vessels having other volumes can also be supported.

[0075] Any typical manufacturing and clean room equipment can be included in the customizable facility 10, and the customizable facility 10 can be fully suitable for cGMP (current good manufacturing practice) processes.

[0076] Examples of some equipment that can be fit in the customizable facility 10 include, but are not limited to: bioreactor, disc stack centrifuge, tangential flow filtration (TFF) skid, depth filtration skid, in-line dilution skid, chromatography columns with associated control equipment, media tank, harvest tank, purification vessels, depth filter holders, water softening and dechlorination system, clean steam generator, water for injection (WFI) storage tank, WFI break tank, WFI still, cooling towers, switchboard, emergency generator, chiller, hydronic pumps, autoclave, air handling units, process waste neutralization (such as a fiberglass reinforced plastic (FRP)), biowaste collection and inactivation system, clean-in-place systems, glass washer, and/or other equipment.

[0077] Bioreactors in the customizable facility 10 of the present disclosure can be ground based reactors. Alternatively, the bioreactors could be suspended from the structure itself. For example, the bioreactors could be suspended from one or more of the modular units 40.

[0078] The customizable facility 10 can include one or more central unit 38 and one or more modular unit 40. In some embodiments, each modular unit 40 is selected from the group of: a fermentation or cell culture unit, a pre- viral unit, a post- viral unit, a utility yard, a warehouse, a media buffer facility, an office, a personnel unit, a production unit, a fill-finish unit, a dosage formulation unit, and a packaging unit. A production unit is useful for manufacturing a product. A fill-finish unit is useful for filling a container such as a vial. A dosage formulation unit dispenses a set dose of a product. A packaging unit packages a product for distribution or sale.

[0079] The space allocated for each modular unit can be divided further as needed to fit specific processing requirements. Each manufacturing wing 22A, 22B can be configured to allow more than one modular unit 40 to be positioned within the respective manufacturing wing 22A, 22B.

[0080] In FIG. 1 and FIG. 2C, a first manufacturing wing 22A comprises three modular units 40. A second manufacturing wing 22B comprises two modular units 40. The central utilities area 20 has a length of 50 meters and a width of 20 meters, and has three internal levels. The central utilities block is expandable.

[0081] In some embodiments, at least one of the modular units 40 is a clean room. In some embodiments, at least one of the modular units 40 includes a clean room section within the respective modular unit 40.

[0082] The building shell 36 is designed to accommodate different production modules.

In some embodiments, the shell can house four 20,000 liter vessels for a mammalian cell line. In some embodiments, the shell can house four 2,000 liter vessels for single-use technology operations.

[0083] In some embodiments, a manufacturing wing can include a modular unit containing four 20,000 liter vessels and downstream processing equipment and configured for manufacturing a monoclonal antibody product derived from a mammalian cell line, a modular unit containing single-use equipment for manufacturing a monoclonal antibody product derived from a mammalian cell line having four 20,000 liter vessels, a modular unit configured for manufacturing a microbial product, and/or a modular unit containing single-use equipment for manufacturing a microbial product.

[0084] In one embodiment, a modular unit is configured for mammalian manufacturing and includes four 20,000 liter vessels and downstream processing equipment. In another embodiment, a modular unit includes four 20,000 liter vessels for commercial and clinical production. In another embodiment, a modular unit includes one 1,000 liter vessel for clinical production. In another embodiment, a modular unit is configured for manufacturing a microbial product, and includes one 15,000 liter vessel. In another embodiment, a modular unit includes three 5,000 liter vessels. In another embodiment, a modular unit includes one or more process development labs. In another embodiment, a modular unit includes fill and finish clinical development vial fill equipment, one or more set of lyophilizing equipment, equipment for manufacturing pre-filled syringes, and/or equipment for manufacturing high potency products for commercial applications. In some embodiments, a modular unit includes cell therapy equipment. In some embodiments, a modular unit includes viral therapy equipment.

[0085] FIG. 2D shows the exterior of the customizable facility 10 in broken lines, with the first office space 24A and the second office space 24B in solid lines. The first office space 24A includes offices, lockers for personal storage, and a support area. The second office space 24B includes offices, lockers for personal storage, and a support area. The front wall 48A of the first office space 24A forms a portion of the front outer surface of the customizable facility 10, as shown in FIG. 2A. The front wall 48B of the first office space 24B forms a portion of the front outer surface of the customizable facility 10. Thus, each office space 24A, 24B is only partially enclosed by the shell 36 of the customizable facility 10.

[0086] Similarly, in some embodiments, an outer wall of the central unit and/or an outer wall of one of the at least one modular units forms at least a part of the outer wall of the

customizable facility. In some embodiments, an upper surface of a central utility module and/or an upper surface of a modular unit forms part of an upper surface of the customizable facility.

[0087] FIG. 2E shows the exterior of the customizable facility 10 in broken lines, with the changing area 18 in solid lines. The changing area 18 allows users to enter the customizable facility 10 and change from street clothes into work clothes. The changing area 18 in FIG. 2E is further subdivided into a male changing area 18A and a female changing area 18B. In some embodiments, the changing area 18 is subdivided into two or more changing areas. In some embodiments, the changing area 18 is not subdivided.

[0088] In other embodiments, the relative positions of the first manufacturing wing 22A and second manufacturing wings 22B, the first office space 24 A, the second office space 24B, the changing area 18, and the utilities area 20 can be positioned differently in the customizable facility 10 and/or oriented differently with respect to the customizable facility 10.

[0089] Scaffolding and corridors 28 allow users of the customizable facility 10 to access the utilities unit 38 of the utilities area 20 and the modular units (fermentation, etc. modules) 40.

[0090] After adding the second phase 14 of construction to the customizable facility 10, over time a user may wish to further expand the customizable facility 10. For example, consumers in the global economy may develop increased demand for a product that the user is manufacturing, or consumers in the global economy may develop increased demand for a product that the user could produce. To respond to such increases in demand for a product, the user can expand the customizable facility 10 in subsequent phases of construction that add additional features to the customizable facility of FIG. 1. In some embodiments, such additional features (such as additional modular units, an additional manufacturing wing, or another component of a customizable facility) are positioned horizontally adjacent to the first

manufacturing wing 22A or the second manufacturing wing 22B. In some embodiments, such additional features are positioned vertically adjacent to the first manufacturing wing 22A and/or the second manufacturing wing 22B.

[0091] Referring now to FIGS. 3A-3E, it is possible for a user to expand a manufacturing wing, such as the first manufacturing wing 22A or the second manufacturing wing 22B of FIG. 1, in different sub-phases. A user could convert a manufacturing wing layout from one of the configurations shown in FIGS. 3A-3E to another configuration shown in FIGS. 3A-3E.

Alternatively, a user could convert a manufacturing wing layout to another configuration.

[0092] FIG. 3A shows a partially exploded view of an embodiment of a modular unit

40A that is configured as a fill finish module. The fill finish module of FIG. 3A has a single floor 60A with a footprint of 1,500 square meters. The fill finish module includes a mezzanine for an HVAC plant room and some localized utilities. A free field 50A is shown in broken lines adjacent to the fill finish module, and has a footprint of 1,500 square meters. The free field 50A can be used for a variety of purposes, such as product storage. Together, the fill finish module 40A and the free field 50A extend over the 3,000 square meter footprint of the second manufacturing wing 22B .

[0093] FIG. 3B shows a partially exploded view of an embodiment of a modular unit

40B that is configured as a "2k module." The 2k module of FIG. 3B has a single floor 60B with a footprint of 1,500 square meters. The 2k module can enclose a 2,000 liter vessel. The 2k module includes a mezzanine for an HVAC plant room and some localized utilities. A free field 50B is shown in broken lines adjacent to the 2k module, and has a footprint of 1,500 square meters. The free field 50B can be used for a variety of purposes, such as product storage.

Together, the 2k module 40B and the free field 50B extend over the 3,000 square meter footprint of the second manufacturing wing 22B.

[0094] FIG. 3C shows a partially exploded view of an embodiment of a modular unit

40C that is configured as "a 5k module." The 5k module of FIG. 3C has a single floor 60C with a footprint of 3,000 square meters. The 5k module can enclose a 5,000 liter vessel. The 5k module includes a mezzanine for an HVAC plant room and some localized utilities. The 5k module extends over the 3,000 square meter footprint of the manufacturing wing.

[0095] FIG. 3D shows a partially exploded view of an embodiment of a modular unit

40D that is configured as a "15k module." The 15k module of FIG. 3D has a first floor 60D and a second floor 62. The 15k module of FIG. 3D has a footprint of 3,000 square meters. The 15k module can enclose a 15,000 liter vessel. The 15k module includes a local HVAC unit, a clean in place (CIP) unit, and a temperature control unit (TCU). The temperature control unit in some embodiments includes water jackets with heat exchangers on a tank to control the temperature of a tank used in a product line. A CIP unit is typically a modular skid and has several tanks to hold a cleaning solution (such as caustic solutions and bleach), pumps, and sensors to send the cleaning solution to the appropriate tank to be cleaned.

[0096] The first floor 60D of the 15k module extends over the 3,000 square meter footprint of the manufacturing wing. The second floor 62 of the 15k module extends vertically above the first floor of the 15k module, and extends above the 3,000 square meter footprint of the manufacturing wing. Together, the first floor 60D of the 15k module and the second floor 62 of the 15k module have a combined area of 6,000 square meters.

[0097] FIG. 3E shows a partially exploded view of an embodiment of a modular unit 40E that is configured as a "20k module." The 20k module of FIG. 3E has a footprint of 3,000 square meters. The 20k module can enclose a 20,000 liter vessel. The 20k module includes a local HVAC unit, a CIP unit, and a TCU. The 20k module includes a first floor, a second floor, and a third floor. The first floor 60E of the 20k module extends over the 3,000 square meter footprint of the manufacturing wing. The second floor 64 of the 20k module extends vertically above the first floor 60E of the 20k module, and extends above the 3,000 square meter footprint of the manufacturing wing. The third floor 66 of the 20k module extends vertically above the first floor 60E of the 20k module and the second floor 64 of the 20k module, and extends above the 3,000 square meter footprint of the manufacturing wing. Together, the first floor 60E of the 20k module, the second floor 64 of the 20k module, and the third floor 66 of the 20k module have a combined area of 9,000 square meters.

[0098] FIG. 4 is a front perspective cutaway view of an exemplary embodiment of a customizable facility generally indicated at 110 according to the present disclosure. The customizable facility 110 layout can be configured for manufacturing in clean room settings. The customizable facility 110 utilizes a hybrid stick or frame build building and modular buildings with a centrally located utility hub (or central unit) 114.

[0099] An outer shell (or shell) 112 encloses a central unit 114 and a plurality of modular units 116 adjacent to the central unit 114. The outer shell 112 can be constructed according to traditional stick building or another method, such as, but not limited to, prefabricated modules. For example, the outer shell 112 can be fabricated from a steel structure using traditional building methods. The outer shell 112 can be supported on footings secured in the ground. The outer shell 112 is weatherproof.

[0100] The outer shell 112 forms a superstructure. In some embodiments, the outer shell

112 can be a "Butler" style building, which is known in the art of building construction.

[0101] The shell 112 includes side walls 118 that are dimensioned and configured to encircle one or more central units 114 and one or more modular units 116 included in the customizable facility 110, and described in more detail below. A roof 120 is secured to upper edges of the side walls 118, with the roof 120 extending over the central unit(s) 114 and the modular unit(s) 116. Thus, the side walls 118 and the roof 120 enclose the central unit(s) 114 and the modular unit(s) 116, which are positioned within the shell 112. The central unit(s) 114 and the modular unit(s) 116 may be supported on a floor 122 of the shell 112 or on another support surface on which the shell 112 is secured. The customizable facility 110 provides a partially-modular (what could be called a modular stick build) method that includes a basic superstructure that is then filled in with modular type elements.

WE claimed

1. A customizable facility for manufacturing at least one pharmaceutical product, the customizable facility comprising:

at least one central unit; and

at least one modular unit in communication with the at least one central unit such that the at least one central unit provides utilities to the at least one modular unit.

2. The customizable facility of claim 1, further comprising a shell, wherein the at least one central unit is positioned at least partially within the shell and the at least one modular unit is positioned at least partially within the shell.

3. The customizable facility of any of claims 1-2, wherein the at least one modular unit includes at least one of a fermentation unit, a pre-viral unit, a post- viral unit, a utility space, a warehouse, a media buffer facility, an office, a personnel unit, a production unit, a fill-finish unit, a dosage formulation unit, and a packaging unit.

4. The customizable facility of any of claims 1-3, wherein at least one of the at least one modular unit is directly adjacent to the at least one central unit.

5. The customizable facility of any of claims 2-4, wherein the at least one modular unit includes a plurality of modular units arranged to maximize a number of modular units within the shell while minimizing a footprint of the shell.

6. The customizable facility of claim 5, wherein each modular unit of the plurality of modular units is directly adjacent at least one of the at least one central unit and another one of the plurality of modular units.

7. The customizable facility of any of claims 5-6, wherein the at least one central unit and the plurality of modular units form a hub and spoke formation.

8. The customizable facility of any of claims 5-7, wherein the at least one central unit and the plurality of modular units are arranged in an H-shaped layout.

9. The customizable facility of any of claims 2-8, further comprising a bioreactor supported on a ground surface within the shell.

10. The customizable facility of any of claims 1-9, further comprising a bioreactor supported within one of the at least one modular unit.

11. The customizable facility of any of claims 2-10, wherein an outer wall of the customizable facility is one of:

formed by the shell, the shell entirely enclosing the at least one central unit and the at least one modular unit; and

formed by the shell and at least one of an outer wall of the at least one central unit and an outer wall of the at least one modular unit.

12. The customizable facility of any of claims 2-10, wherein the shell includes at least one side wall, the at least one side wall encircling the at least one central unit and the at least one modular unit, and a roof secured to an upper edge of the at least one side wall, the roof extending over the at least one central unit and the at least one modular unit.

13. The customizable facility of any of claims 1-12, wherein at least one of the at least one modular unit is a clean room.

14. The customizable facility of any of claims 1-13, wherein the at least one modular unit is configured for cell therapy operations.

15. A method of assembling a facility for manufacturing at least one pharmaceutical product, the method comprising:

providing at least one central unit; and

providing at least one modular unit in communication with the at least one central unit such that the at least one central unit provides utilities to the at least one modular unit.

16. The method of claim 15, further comprising

providing a shell;

positioning the at least one central unit at least partially within the shell; and

positioning the at least one modular unit at least partially within the shell.

17. The method of any of claims 15-16, wherein the at least one modular unit includes at least one of a fermentation unit, a pre- viral unit, a post- viral unit, a utility space, a warehouse, a media buffer facility, an office, a personnel unit, a production unit, a fill-finish unit, a dosage formulation unit, and a packaging unit.

18. The method of any of claims 16-17, wherein the at least one modular unit includes a plurality of modular units arranged to maximize a number of modular units within the shell while minimizing a footprint of the shell.

19. The method of claim 18, wherein each modular unit of the plurality of modular units is directly adjacent at least one of the at least one central unit and another one of the at least one modular unit.

20. The method of any of claims 18-19, wherein the at least one central unit and the plurality of modular units form a hub and spoke formation.

21. The method of any of claims 18-20, wherein the at least one central unit and the plurality of modular units are arranged in an H- shaped layout.

22. The method of any of claims 16-21, further comprising one of supporting a bioreactor on a ground surface within the shell and supporting a bioreactor within one of the at least one modular unit.

23. The method of any of claims 16-22, wherein an outer wall of the customizable facility is one of:

formed by the shell, the shell entirely enclosing the at least one central unit and the at least one modular unit; and

formed by the shell and at least one of an outer wall of the at least one central unit and an outer wall of the at least one modular unit.

24. The method of any of claims 16-22, wherein the shell includes at least one side wall, the at least one side wall encircling the at least one central unit and the at least one modular unit, and a roof secured to an upper edge of the at least one side wall, the roof extending over the at least one central unit and the at least one modular unit.

25. The method of any of claims 15-24, wherein the at least one pharmaceutical product is a biosimilar product.