As the pharmaceutical industry slowly moves away from its very conservative approach to manufacturing and starts to embrace more efficient and flexible technologies to bring products to market faster and with increased quality, the use of prefabricated cleanroom suites has emerged as a very effective way to quickly get facilities, from lab to production environments, up and running.
G-CON Manufacturing, a Texas based company, designs, builds and installs prefabricated cleanroom PODs for a variety of purposes, from laboratory environments to personalized medicines and even production process platforms.
As the leader in prefabricated turnkey cleanroom solutions, G-CON PODs represent a significant development in pharmaceutical and biopharmaceutical production. PODs provide the only system that is readily deployable, flexible, mobile and scalable in the cleanroom market.
American Pharmaceutical Review toured the company’s facility and spoke with many of their executives to learn about the company, its services and expertise, and how its pre-fabricated cleanroom suites help pharmaceutical companies bring lifesaving treatments to market.
Company Background and History
As is the case with most new companies; necessity is the mother of invention, as Sid Backstrom, the company’s Vice-President of Business Management described how the company started, “G-CON got started in 2009 when our founder, David Shanahan, was looking for a cleanroom solution for his autologous cancer vaccine company called Gradalis.”
The company was formed to simplify the entire design/build/validate process via a prefabricated cleanroom infrastructure line so pharmaceutical companies can focus on what really matters, the patient.
Backstrom continued, “Dave had a crew of people available at that time, some that were very good at construction, some that were very good at process design, so they sat down and designed the POD concept.”
At the time the company had a staff of 8 people and 12,000 square feet of rented manufacturing space.
G-CON has grown over the years and now boasts a staff of 140 people and 200,000 square feet of owned manufacturing space across 11 buildings. They expect to reach 200 employees by the end of this year.
In addition, the company has grown and expanded to offer dedicated resources in quality, commissioning, project engineering, project management, sales and sales engineering, procurement, logistics and automation.
As the company has grown, so too has its output. G-CON’s manufacturing capability has expanded from 40-50 PODs per year to over 200 PODs per year. In addition, G-CON recently launched a new entity, G-CON Building Services, that enables the company to deliver more comprehensive facility solutions that includes PODs, integration of PODs to the host facility and host facility renovations as well.
“G-CON Building Services is a separate entity from G-CON Manufacturing.” says Blake Williams, VP of Operations, “This subsidiary of G-CON is stocked full of senior project managers that are able to actually deliver the full-on customer experience. We’re well versed in the engineering process, not only for the PODs but the host facilities. Whenever we come down and talk to the clients, we’re really talking on their behalf. We’re making sure that everything’s tied together effectively. That goes through the build, that goes through the commissioning phase. We’re making sure that everything’s tied together and you don’t have any loose ends.”
PODs Defined
At its most basic description, the G-CON POD is a prefabricated cleanroom unit, built and prequalified off-site via a Factory Acceptance Test (FAT).
To accommodate all needs, G-CON offers a wide variety of prefabricated cleanroom solutions ranging from their line of standard PODs to project specific PODs. The company’s standard portfolio can accommodate most upstream and downstream processes. If site limitations are present or oversized process equipment required, G-CON can design and build a custom POD or series of PODs. In either form, PODs provide many standard features and finishes to enable a streamlined and efficient commissioning and validation process as opposed to a unique process for each cleanroom space.
Maik Jornitz, President and CEO, provided more insight, “We build it off-site; we pre-qualify it off-site and then move the unit to the customer’s site where it will be utilized as a cleanroom infrastructure to manufacture therapeutic drug products. G-CON PODs are mobile systems. It’s not like what you have with traditional cleanroom infrastructures, where you buy bits and pieces. Our PODs are fully functional cleanrooms and you can utilize it whenever you want to.”
In addition to the Factory Acceptance Test, G-CON performs a Site Acceptance Test after shipping, and provides each customer with a comprehensive engineering turnover package that provides full traceability of components, finishes and structural details.
Creating the “Ideal” Production Facility
The need for cleanrooms or contained environments vary greatly in the pharmaceutical industry, and are primarily contingent on the product being developed or produced. PODs are specifically designed to be used in the most challenging of settings including cell and gene therapy, aseptic fill finish and continuous bioprocessing. It is therefore imperative that G-CON and a prospective client review the deliverables desired, and the expectations for each project, before it gets underway.
Backstrom describes the steps the company takes when evaluating a new project. “We start with our business development people. When they decide that there is what we call a ‘POD worthy project’, it goes over to our sales engineering department where they provide two and 3D designs for the customer with budgetary quotes provided as well. Then, if a customer decides that all looks good and it’s something they want to do; the sales engineer will then hand that over to a project manager. Our engineering team will then order all the materials and really work with our technicians on the manufacturing floor to build it according to specification.” The manufacturing process is an SOP (standard operating procedure) driven approach, with multiple crafts working together on each POD. “We have several different groups on the manufacturing floor,” Backstrom continued. “We have technicians that are skilled in building the structures, electricians and automation experts. Then after we finish the build process, it goes through our commissioning team who really takes over, does a factory acceptance test and then a site acceptance test.”
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New Markets, New Treatments
As the pharmaceutical industry continues to broaden its portfolio of products to treat patients, one of the most promising areas has been the incredible growth of cell and gene therapies. With its deep knowledge and experience in developing controlled environments, G-CON has adeptly moved into this market segment and is seeing an increased need for its PODs for autologous and allogeneic cell therapies, gene therapies, and viral vectors. PODs are ideal for these products as these targeted and patient-based medicines require smaller and more robust containment solutions to reduce the risk of secondary contamination. G-CON can deliver multiple cleanroom PODs for cell and gene therapy applications in as little as 6 months as opposed to a more typical timeframe of one year or more as is expected with other traditional and modular options. Also, in cell and gene therapy, it is commonly unknown how much capacity is required at the outset. Therefore, scale up is often necessary, and must be done without delay. By employing their autonomous cleanroom PODs, users can easily scale out by adding more PODs rapidly and without interrupting the existing processes. Users are then able to utilize the same process platform and clone them for use in other regions, with abbreviated or even no design time, resulting in even faster delivery.
“The POD technology can really be applied to any application where a cleanroom or a contained environment is required,” says Dennis Powers, VP of Business Development and Sales Engineering, “The most significant growth is going to be in the cell and gene therapy space, but certainly, we see the opportunity to grow the business in aseptic fill finish and continuous manufacturing.”
Powers continued, “From the very beginning, our PODs have been well aligned with the needs of cell and gene therapy manufacturing. We can provide a pre-engineered design that offers a more comprehensive turnkey solution saving time and money for companies that need to design and build a new facility. Our approach could mean that companies developing new personalized therapies can get products to their patients within months rather than years, which has, up until now, been the benchmark.”
Industry Collaborations
Providing a product that can significantly shorten the timeline to bring a new product to market is a rare accomplishment in this industry; and G-CON has achieved that accomplishment. One of the ways, G-CON has achieved this success is through its collaborations with some of the top technology and service providers in the industry. Some of the company’s most relevant collaborations include:
Microcell POD
In collaboration with Vanrx, G-CON Manufacturing has developed the Microcell POD, the first and only turnkey solution for aseptic filling of advanced therapies. Comprised of a Vanrx Microcell Vial Filler installed inside a G-CON Prefabricated Cleanroom POD, the Microcell POD supports both companies’ missions of providing solutions that bring drug products to market faster.
Pall Viral Vector POD Platform
Pall’s viral vector equipment, process development (PD) expertise, and production know-how address industry’s most pressing challenges. Coupled with G-CON’s prefabricated cleanroom PODs, this collaboration delivers a scalable platform in a flexible facility that is rapidly deployable and able to be repurposed to respond to changing requirements.
iCON
IPS and G-CON have partnered to create iCON, a turnkey modular facility platform solution for the biomanufacturing industry. The collaboration provides the most flexible and rapidly deployable facility platform, meeting the modular and mobile demands of the industry.
The iCON team’s broad range of technical capabilities and services along with prefabricated cleanroom PODs provides a true turnkey solution to biopharmaceutical manufacturers and CMOs with needs for production agility and capacity flexing.
GE Healthcare Off-the-Shelf GMP Manufacturing in PODs
The time and steps required to get cell therapy manufacturing facilities up and running can be challenging. That is why GE Healthcare and G-CON have collaborated to simplify the process. A FlexFactory production line in a prefabricated G-CON POD® offers a turnkey platform that is GMP compliant.
Looking Ahead to the Future
In a dynamic industry like pharmaceuticals, companies can’t afford to stand still. With its broad range of products, services and collaboration, G-CON continues to innovate and improve its market leading cleanroom and contamination control solutions. “The future vision of G-CON is that we can standardize these cleanroom infrastructures and start mass-producing cleanroom PODs,” said Jornitz. “When we mass-produce these cleanroom PODs, we are bringing down the cost and we are actually speeding up the delivery time. The second benefit to standardization and mass-production of PODS is that we will be able to deliver turnkey facility packages for companies developing monoclonal antibodies, vaccines, and cell and gene therapies.”
Jornitz continued, “Then, another vision which we see is that there would be a very big benefit to creating small scale mobile manufacturing facilities. One of our hopes, really, in that regard is that we see our trucks with cleanroom PODs moving into a warehouse in sub-Sahara Africa and start producing vaccines for the local population. At G-CON we want to give our customers the option of having proven turnkey facilities at their disposal.”
Bringing drugs to patients quickly and efficiently, and to have that drug available where needed is the ultimate goal for G-CON and its POD solutions. With a wide range of solutions, services and collaborations, G-CON is perfectly positioned to meet that goal.
G-CON Manufacturing, Inc.
6161 Imperial Loop
College Station, TX 77845
Phone 979.431.0700
www.gconbio.com