Autonomous Cleanroom PODs™ flexible, scalable, and mobile processing solutions Designing the Future of Biopharmaceutical Processing True Facility Flexibility Providing Fast, Scalable, Comprehensive Cleanroom and Containment Solutions G-CON PODs™ offer a solution that reduces budget and Autonomous Cleanroom PODs™ facility constraints by providing readily deployable, mobile, scalable, and fully self-contained cleanrooms. G-CON Manufacturing is equipped with the resources and experience to transform the industry by providing unmatched manufacturing flexibility with a growing product portfolio, including standard PODs™, miniPODs™, Transmissible Disease Containment (TDC)PODs™, and the megaPOD™. Process Equipment & Electronics Integration Use of control PLC’s POD™ Design Features Independent fire suppres- Robust aluminum con- that are fully com- sion system struction patible with Factory Ample working space for Drip-free quick connects Talk and other pro- for utilities, like water & cess management electricity software pieces of process equip- Plug and play option due PAT connectivity for to air bearings, which data storage and process control On board controllers integrate mechanical systems with process & building management systems multiple personnel Can accommodate large ment Dual POD™ configuration makes it easy to move doubles cleanroom area the POD™ around and allows for easy trans- Flexibility in designs utiliz- ing our engineering & design partners portation PODs™ can be sanitized using VHP decontamination Failsafe HVAC Systems On Board Automatic failover for continuous operation Mechanical systems are Easy to service and main- tain Cleanroom classifications accessed from the ‘gray of ISO 5-8 available or space’ containment options of BSL 1-3 Compact ductwork to avoid leaks and energy losses BIBO HEPA filter system Gown-in | Gown-out & Equipment Airlock Provides control for personnel flow at each POD™ Optional without Gown-in | Gown-out, adds an addi- tional square footage to the POD™ working area Standard POD™ Dimensions 9’W x 42’L x 11.5’H 234 Sq. Ft. Cleanroom Area (2.74m x 12.80m x 3.51m) (21.8 Sq. Meters) 12’W x 42’L x 11.5’H 312 Sq. Ft. Cleanroom Area (3.66m x 12.80m x 3.51m) (29.0 Sq. Meters) 18’W x 42’L x 11.5’H 468 Sq. Ft. Cleanroom Area (5.49m x 12.80m x 3.51m) (43.5 Sq. Meters) 24’W x 42’L x 11.5’H 624 Sq. Ft. Cleanroom Area (7.32m x 12.80m x 3.51m) (58.0 Sq. Meters) * POD cleanroom area w/ Gown-in|Gown-out / equipment airlock *Customized systems are available POD™ Product Portfolio Standard POD · miniPOD· TDC POD· UnitOp PODs™ Established in: Analytical/ Microbial Laboratory Therapeutic vaccine Lab infrastructure mAb (single and multi- Fill finish product processes) OEM ready to use OSD Transmissible disease Personalized medicine containment Personalized Medicine/ PCR Laboratory Benefit Case Scaling without inter- ruption 9’W x 25’L x 11.5’H ≥100 Sq. Ft. Cleanroom Area (2.74m x 7.62m x 3.51m) (10.0 Sq. Meters) 9’W x 42’L x 11.5’H ≥230 Sq. Ft. Cleanroom Area (2.74m x 12.8m x 3.51m) (23.0 Sq. Meters) and corridor incorpo- 9’W x 50’L x 11.5’H ≥300 Sq. Ft. Cleanroom Area rated (2.74m x 15.24m x 3.51m) (30.0 Sq. Meters) Opportunity to delay time to investment Unidirectional flow Dimensions 9’W x 50’L x 11.5’H ≥300Sq. Ft. Cleanroom Area (2.74m x 15.24m x 3.51m) (21.8 Sq. Meters) Unit Operation Single-use Unit Operations Can be outfitted with single-use equipment or Transmissible Disease Containment unit operations Benefit Case Rapid design and deployment Fast deployment Containment with redundancy functions Integrated decontamination methodologies Rapid process flow connectivity available for proper sanitization and repeated use Dimensions 8.5’W x 50’L x 11.5’H ≥ 250 Sq. Ft. Patient Area (2.59m x 15.24m x 3.51m) (≥ 23.2 Sq. Meters) Designing the Future of Biopharmaceutical Processing POD™ Facility Platforms MONOCLONAL ANTIBODY · PERSONALIZED MEDICINE · CELL-BASED VACCINE RECOMBINANT PROTEIN· AUTOLOGOUS VACCINE G-CON and their A&E partners provide PODified facility platform solutions which are designed to meet customer requirements. PODs™ are constructed with the flexibility to be easily relocated or repurposed for the next drug product release or alternative applications. PODs™ can be placed in an existing warehouse space or brown/greenfield site, allowing for easy facility expansion or cloning of facilities in multiple locations for fast track facility build-up . Conceptual 2,000L Monoclonal Antibody Facility PODified Single-Use mAb Production Facility Rapid construction period < than 18 months Lower cost of capital Ability to use pre-existing space Easily expandable Processes modification with high flexibility Capable of multi-product campaigns per year Conceptual Single Use Cell-Based Vaccine Facility PODified Single-Use Cell-Based Vaccine Facility Rapid deployment of capacity demand Robust containment and BSL 1 to BSL 2+ segregation Ease of up and down scalability Lower total project costs Designing the Future of Biopharmaceutical Processing PODs™™ - Realized Process Opportunities Design Features Mobile – All PODs™ come equipped with air bearings and crane hookups for transport and installation Reusable – PODs™ can be easily re-commissioned for a different project or application Durable – All aluminum construction for extreme corrosion-free operating life and unequivocal robustness Decontamination – PODs™ can undergo VHP decontamination or other gassing strategies, allowing for quick turnover between campaigns and quick decontamination in the event of a containment issue Energy efficient – PODs™ can be configured to re-utilize conditioned air from the clean space and do not comprise of excessive ductwork Integrated Utilities HVAC – fully failsafe with automatic failover for continuous worry-free use Information Technology (IT) hardware – control PLCs plus a 14-port switch for direct interface of process equipment and HVAC data output On board fire prevention – fire suppression system suppresses fires and communicates with any BMS Utilities connections – zero drip quick connects for connection to water and electricity. No additional wiring needed Process piping – cGMP process piping can be integrated based on customer requirements Built-in Qualification Documentation Commissioning – engineering turnover package included with each unit Factory acceptance testing prior to delivery Validation and qualification provided by our partnering firm Costs Reduction Opportunity cost – Other methods interrupt operations Floor construction (poured epoxy floors included in every POD) Integration of building utility systems and processes in a step by step mode On-site construction management POD™ Benefits Lower cost of growth On demand scalability Requires only “gray space” Enables fast-track construction Fraction of the cost of traditional builds PODs™ arrive commissioned with a compliant engineering turnover package Predictable cost & timeline Ideal for multiple applications and process technologies Repurposable after product life cycle expiry Process Features Integration of single-use systems, unit operations or processes Standardized hardware equipped with flexible pre-sterilized process systems Options for pre-engineered solutions, for example fill/finish Implementation of compact processing designs Designing the Future of Biopharmaceutical Processing POD™ Applications The flexibility and PODularity of self-contained PODs™ creates a variety of choices on how to utilize the PODs™ to its best purposes: PODs™ Can Be Integrated Into New “green field facilities” investments Existing structures (utilization of the shell and utilities) Rapid deployment for small and pilot-scale operations Multi-product, multi-purpose facilities Scalable, capacity ramp-up for commercial scale Re-deployment for other purposes than the intended application Mobile small scale production facilities for regional expansions Contract manufacturing basis to define individual PODs™ to individual clients Any containment needs to create a clean space inside or to protect the environment from what is inside the POD Mobile surgery or patient treatment systems or centers Performance Comparison PODs™™ Traditional Offsite Build Modular Panel Wall Cleanroom Isolator Based All pharma classifications possible ✓ ✓ ✓ Robust (durable) ✓ ✓ ✓ ✓ ✓ ✓ significant user interaction ✓ ✓ ✓ Fully integrated ✓ Lower cost of capital ✓ ✓ ✓ Can be used in ‘gray space’ ✓ ✓ ✓ ✓ ✓ Provides multi-level containment for equipment and processes ✓ Can accommodate equipment with ✓ Simultaneous gray space | cleanroom build possible ✓ Scalable (easy to add additional processes) ✓ Can be re-purposed and re-configured ✓ Portable (can be moved “as is”) ✓ Self-contained ✓ ✓ Low cost commissioning, qualification & validation ✓ Flexible use (re-arrangement of process elements) ✓ Designing the Future of Biopharmaceutical Processing Clinical Timelines and Facility Requirements POD™ based facilities can be designed, built and validated faster than conventional solutions at significantly lower cost (according to a case study ~58% of traditional site). PODs™ provide unmatched manufacturing flexibility and the assurance of a commissioned environment. PODs™ can also be leased to further reduce the risk of failure related costs. To a biopharmaceutical manufacturer this means reduced: Risk Capital investment Cost to operate Time to market The possibility to regain the investment A Typical Workflow PODs™ can be designed, built, supplied and commissioned much faster than conventional facilities. The key to success in being expeditious is the close team work together with our clients. Your success is our success. Designing the Future of Biopharmaceutical Processing Designing the Future of Biopharmaceutical Processing 6161 Imperial Loop College Station, TX 77845 Telephone 855.751.GCON Fax 979.822.2623 Mailing Address P.O. Box 15922 College Station, TX 77841 e-mail [email protected] Sales and Product Inquiries e-mail [email protected] Website www.gconbio.com Check our leasing options Media Telephone 979.314.7452 e-mail [email protected] Vendors and Channel Partners Telephone 979-314-7473 e-mail [email protected] Get your conceptual layout FREE - contact us !
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