G-CON Manufacturing

G-CON’s autonomous cleanroom PODs are designed and constructed with a failsafe, heating, ventilation and air-conditioning (HVAC) systems, an automatic failover for continuous operation, as well as efficient ductwork.

Other features include a bag-in / bag-out high-efficiency particulate air (HEPA) filter system, a robust aluminum structure and drip-free quick connects for utilities.

A ‘plug-and-play’ option is also available, which uses integrated air bearings, an independent fire suppression system and mechanical systems, with access from warehouses possible. PODs provide comprehensive, flexible and scalable manufacturing solutions for the biopharmaceutical industry.

Monoclonal antibodies and cell-based vaccines applications

PODs can be utilised in applications that include monoclonal antibodies, cell-based vaccines, recombinant proteins, personalised medicine, gene therapy, lab infrastructure and transmissible disease containment.

PODs can be dedicated to a process step or deployed as a small volume total process containment solution, comprising glove boxes or isolators.

In addition, PODs can be easily decontaminated and used for multiple products. The systems are available in different sizes with customisable options.

Applications and services available for the system include ISO 5, ISO 8, biosafety level (BSL) 1 and 3, commissioning, factory acceptance test (FAT) and site acceptance test (SAT).

G-Con, along with collaborating A&E firms, provides PODified facility platform solutions designed to meet client requirements. The systems are constructed to ensure they can be easily relocated or repurposed for the next drug product release or alternative applications.

POD platforms for bioprocessing across multiple locations

PODs can be placed in an existing warehouse space, brown or green field site, which allows easy facility expansion or cloning of facilities in multiple locations for fast track facility build-up.

The company’s rapid construction period is under 24 months. G-Con aims for lower cost per capital, scalability and uses pre-existing space.

POD platforms support a wide array of bioprocessing needs, including:

• Pilot projects for small scale projects that require scalability
• Pilot facility for use in multi-product and multi-tenant facilities where separate operations are essential
• Scale up, designed for projects that are experiencing successful growth
• Full-size commercial, which supports processes and results in hundreds of millions of doses of therapeutics every year
• Retrofit, which can transform existing warehouse spaces or other non-classified space into a good manufacturing practice (GMP) quality production area

Energy efficient and VHP decontamination systems

The POD system is designed to be mobile, and is equipped with air bearings and crane ‘pick-points’ for easy transportation and installation.

PODs can easily be re-commissioned for different projects or applications. The aluminium construction ensures the system has a corrosion-free operating life.

Quick turnover between campaigns and swift decontamination in the event of a containment issue is possible through vaporised hydrogen peroxide (VHP) decontamination and other gassing strategies. PODs are energy efficient by re-utilising conditioned air from clean space.

G-Con designs and constructs multiple PODs, with installations at reference sites such as Caliber Biotherapeutics in Bryan, Texas, US.