Changing the Face of Biopharmaceutical Cleanroom Infrastructures
G-CON Manufacturing Inc. is an accelerating business dedicated to providing prefabricated turnkey cleanroom systems. The unique, mobile cleanroom units, called PODs, are built in its College Station, Texas-based factory and then shipped and installed at the customer’s facility, wherever in the world they may be.
The pioneering business was founded in 2009 by a group of innovative individuals who developed a desire to create autonomous cleanroom units after one of the founders, who ran a cancer vaccine business, became fed up with traditional cleanroom systems which were connected to the centralized air handling, electrical, and piping systems. The main frustrations were the existing process disruptions, detrimental to the treated patient base, and the time-consuming cleanroom construction with high personnel densities at the site. After conceptualizing and creating the first unit, the founders soon realized that these prefabricated, autonomous cleanroom systems were viable on an industry-wide scale as the need for flexible facilities became a constant demand by the industry, and G-CON was born.
G-CON’s prefabricated containment cleanroom systems are known simply as PODs, but instead of containing young seeds, these cleanroom PODs are used to keep sensitive, life-saving biopharmaceutical materials free from environmental contamination. PODs can be used in many applications including monoclonal antibodies, vaccine or recombinant proteins, personalized medicines, cell and gene therapy, and even laboratory use.
These PODs are built and factory acceptance tested on G-CON premises before being shipped to customers and site acceptance tested at their location. This process is much quicker and more convenient to the customer than the traditional method of building cleanrooms, as the productivity ratio of construction off-site is 100 percent and at the customer site around 70 to 80 percent, due to time consuming logistics and personnel movements.
“With every structure we have completed, we were always much faster than the traditional builder,” says Maik Jornitz, President and CEO of G-CON. “We have examples where a complex cleanroom infrastructure takes 18 months to complete with a traditional builder. It takes us just 10 months to build the infrastructure, and then we introduce the PODs into the building within hours, interconnect them in two weeks, followed by the site acceptance test. We like to raise the question, whether you would like to have 100 workers at your site for 18 months or 10 of our team members for few hours?”
The leading manufacturer works with pharmaceutical and biotechnology customers to create the design they require for their specific application, first taking into consideration issues such as material, personnel, and waste flow. To support this activity, G-CON makes a multitude of predefined document templates available – for example, a URS template and for later qualification purposes, IQ/OQ templates. Once the design is established, G-CON begins cleanroom construction by building an aluminum superstructure, with an extruded floor built first, followed by the structural, wall and ceiling components.
Once the initial box structure of the POD is built, G-CON commences installation of internal wall systems and outfits the space with ductwork, air handling systems, fire alarms, automation and controls, doors, windows, and flooring (vinyl or epoxy coated), all depending on the customers’ requirements and detailed design.
“Whatever the customer wants to have within that cleanroom POD structure, we are able to install. We have standard POD designs, which have been pre-designed and will abbreviate delivery timelines,” explains Jornitz. “However, most of our current projects are custom designed structures, often large area POD clusters, which are a multitude of interconnected PODs. Once the PODs are built and outfitted, we run a factory acceptance test to evaluate that all the predetermined specifications are met. We see this test as an essential benefit of an off-site built, as anything which is not correct can be rectified at our site, instead of the client’s site.”
Once the POD structure has passed the factory acceptance test (FAT), the individual PODs are sealed and wrapped and shipped via truck. After the truck arrives at the customer’s facility, G-CON’s installation team moves the PODs into the building and starts interconnecting the individual units. Depending on the size of the project the team can range from two to ten members. This is the only time when the customer will have to deal with a significant number of G-CON’s team onsite.
The cleanroom units are moved using air bearings. With compressed air on the bearings, the PODs flow like a hovercraft into place and are then connected. Once interconnected, G-CON will seal them and put the electrical connections and piping in with an installation crew of two to three people. Finally, the new POD infrastructure is site acceptance tested.
The entire process is completely different from the traditional method of constructing cleanrooms, which typically involves a large crew of people for many months. This method can disrupt a customer’s existing, running processes, creates a high worker density, which requires supervision and insurance and often adds hidden costs – for example, the required temporary parking.
“Discussions with engineering and facility experts of the industry revealed a frustrating trend. Quotations given to end-users often state an estimated cost per square foot including a percent cost variability and proposed timeline of accomplishment, which most of the time is not met. We asked a large group of end-users of different industry applications and none have seen a robust budget and timeline quote. The initial, foot-in-the-door, quote costs crept up and were elevated by change orders. At G-CON we believe that budget and delivery time robustness is an essential part to support our industry. We deliver what has been agreed upon in time and at the price quoted,” says Jornitz.
Another major difference between PODs and traditional cleanroom structures is that traditionally, the structures are fixed where they’re installed. If a client wants to move their facility, it’s a sunk asset that must remain in that building. With PODs, this is not the case. Customers can move their PODs as desired: take them apart, float them out, wrap them up, and put them in a truck to be sent away. This can have multiple advantages: for one, a POD user can work in a temporary location until an end location is found. Other benefits of mobility are the shifting of capacities to different locations when needed or pulling assets from a volatile region. PODs can also be repurposed, as these last for a multitude of product lifecycles. Being compact, these units can be easily cleaned and sanitized with vaporized or ionized hydrogen peroxide.
“We had one client who used a POD for three years. He didn’t need it any longer. We bought that POD back from him and resold it. It’s like the car industry; a certified pre-owned vehicle and a certified pre-owned POD. We refurbished and resold that POD,” mentions Jornitz, adding that PODs – which are movable – are also available for leasing. This makes them an even more flexible solution for biopharmaceutical startups, which may not have the capital on hand to purchase a cleanroom right away.
Although PODs are now a preferred solution by many of G-CON’s clients, Jornitz tells us that when he started working at G-CON back in 2012 as Vice President of Business Development, the business was not nearly as well-known.
“PODs, or prefabricated cleanroom units, were totally new. There were some container-based structures, but nothing like our POD infrastructures. We had to convince not just the industry, but the A&E firms that we are a viable and beneficial cleanroom tool in the tool box of cleanrooms. It took us a while until our conservative customer base realized the advantages in flexibility, speed and total cost of ownership. Now, we are not any longer in the innovator phase, but have reached the early majority phase. This also means we are preparing our capacities accordingly and started a multitude of expansion projects,” he remarks.
The now nine-year-old business was able to get the word out about its one-of-a-kind product through creative marketing activities, publications and presentations. Jornitz’s team enjoys writing, and there are several technical publications available about G-CON’s capabilities. The manufacturer is also an active participant at many conferences and exhibitions, including the Interphex, which was held just this April in New York City. The company has also won several awards for its innovations, including the 2016 Facility of the Year (FOYA) award, given by International Society for Pharmaceutical Engineering. The award was granted to the PCMM consortium, a POD facility that was a collaboration between Pfizer, G-CON and GEA.
In other recent news, G-CON Manufacturing installed prefabricated cleanroom PODs for Just China’s state-of-the-art biologics facility in the Hangzhou Economic & Technology Development Area (HEDA) overseas. Hangzhou Just Biotherapeutics (Just China) is an affiliate of Biotherapeutics (Just). According to a press release, it is the first commercial facility for Just, a company formed to significantly reduce the cost of biologics in order to make them globally accessible.
Another recent project, completed in late 2017, involved the delivery of a POD system to AveXis, Inc., a gene therapy company. AveXis specializes in developing treatments for patients suffering from rare and life-threatening neurological genetic diseases. A press release reports that the new POD-based facility serves as the production site for supplying pivotal and future trials for AVXS-101, a proprietary gene therapy candidate of a one-time treatment for patients with spinal muscular atrophy.
As more and more companies gain awareness of G-CON’s forward-thinking solutions, the business will need to expand. At the moment, G-CON is running through a spur of expansion, doubling its manufacturing capacity in College Station, Texas, with more possibilities of manufacturing space on its eight acres of acquired land.
G-CON is experiencing a tremendous pull from the industry, and wants to be able to fulfill those demands. Eventually, it will not only need a bigger North American headquarters, but also a location in another continent. “We just signed a manufacturing agreement with Asgard, Ireland, which has a 120,000 square foot manufacturing capability. Our teams are now working actively together to get this site up and running. We see this as a major benefit for our European customer base, as they can visit the site and see their projects come to life,” tells Jornitz.
Having an increasing number of clients require immediate cleanroom space, G-CON also projects the need for standardized, rapid delivery of PODs on the horizon, meaning that the business will need to start keeping an inventory of PODs on hand. As more and more new, personalized therapies are being approved, rapid capacity expansions are needed. This can only be accomplished with readily available POD inventory. In addition, the biotech industry kept hundreds of millions of dollars of product inventory before the biologic therapy was launched, just to overcome capacity restrictions. These capacities need to be built much faster and should have the ability to flex. Rapid, timely delivery and full capacity utilization are an essential need to reduce costs of goods sold. Large scale POD structures can be delivered in less than a year and if parts of the POD cleanroom structure are not needed, they can be sealed and shut down; since these units can have an autonomous HVAC system, it can be done.
“Ultimately, my vision is that we will have showroom locations in different parts of the world. Customers can have a look at the cleanroom PODs and buy them off the shop floor. We’ll reconfigure them and ship them out in 48 hours. I know it is a daring vision, but what is more complicated in a cleanroom than in a car?”
For project-based systems, the G-CON team plans to create turnkey facility templates with POD infrastructures in them, with a shell building around them and all other utilities. With that, it can create template catalogs, and even conduct virtual reality tours.
“A client can say, ‘I would like to see a viral vaccine facility layout,’ and we can hand them a catalog. They can flip through the pages and say, ‘This is the right template. I would like to see this one in more detail.’ And then we’ll give them goggles so they can walk through the site and make the necessary changes. With that, we abbreviate the design phase and have a much more rapid deployment of such a system,” Jornitz describes.
Of course, a bigger company will also require a bigger team. The growing manufacturer now employs 55 people in Texas; in the very near future, Jornitz would like to double that number. People with a variety of skill sets will be required to fill these positions, especially as the business is growing into a global reach. Before G-CON’s tenth anniversary, the cutting-edge manufacturer is projected to have an employment number in the triple digits.
“There is a multitude of personnel we want to hire and grow as we continue to grow the company. Ultimately, we make a promise to our customer, whether a price, delivery time, qualification activities or documentation. We will keep this promise and to do so we need the right team members – dedicated, knowledgeable and fun to work with. We love what we do, as we firmly believe what we do will help patients!” he concludes.