- Build new, commercial scale biotherapeutics-production facility that would produce a vaccine 3 times faster than normal, be built 7 times quicker, at 10 percent of the usual cost.
- Design and Delivery – G-CON worked with Rockwell Automation Global Solutions Team to develop and deliver PODs – autonomous, self-contained clean rooms that enabled the facility and the critical processes to be constructed concurrently
- Information-enabled Control System – Allen-Bradley ControlLogix controllers control the POD’s HVAC system and ensures that the POD’s precise environmental conditions are met
- FactoryTalk software – continuously collects and analyzes data to provide a cGMP compliant environment and a quality control data record
- Constructed new 145,000-square-foot production facility within 12 months. Product produced in 21 months.
- Project’s success has helped G-CON’s efforts to market and sell their innovative PODs as a solution for biopharmaceutical manufacturers around the world – with Rockwell Automation hardware, software and support being a critical part of the product.
From the discovery of a newly created drug, a drug manufacturer has a limited amount of time to reap the rewards of its invention before its patent expires and generic products enter the market.
For this reason, speed is of paramount importance. Traditionally, drug manufacturers have built inflexible, cost-prohibitive production facilities that take three to seven years to complete and even longer to validate for production. With the advent of single use technologies and process improvements, a paradigm shift is occurring making such large scale facilities a thing of the past. Instead, modular, scalable, flexible manufacturing solutions are the industry's goal. G-CON, a builder of biotherapeutics-manufacturing facilities, created the POD platform to respond to this need.
“In our experience, PODs have proven to be the most comprehensive offering on the market today,” said Barry Holtz, Chief Science and Technology Officer of G-CON.
Vaccines for large populations typically take 10 to 17 years to move through the clinic to licensure. But for critical situations like pandemics and biological attacks, years must be collapsed into months or even weeks. Recognizing that the country had no such capabilities after the H1N1 pandemic, the Defense Advanced Research Projects Agency (DARPA), a division of the Department of Defense, awarded G-CON a grant that sought to address this major concern. Within 21 months of signing the contract, G-CON had to be able to produce a plant-produced recombinant protein for an influenza vaccine at a rate of 100 million doses per year.
Using a plant-based protein source represented a change versus traditional vaccine production and would require a shift from the typical pharmaceutical manufacturing facility's design. Because plants would serve as the upstream bioreactors, multiple purification systems needed to be “at the ready” to produce medical countermeasure proteins. DARPA selected G-CON's cleanrooms, also know as PODs, for its downstream facilities to accomplish this goal.
Completing the project would be no small feat: G-CON had to develop a vaccine three times faster than conventional systems, scale the process to commercial capacity, and design and construct the facility seven times faster, at 10 percent of the usual cost. All the while, the team had to ensure production occurred under stringent manufacturing guidelines.
Traditionally, drug manufacturers will undergo years of drug development before building a commercial scale facility. Once a facility is needed, construction occurs in a sequential fashion with the cleanroom build-out occurring last. Instead of following this traditional and time-consuming path, G-CON chose to partner with the Global Solutions team at Rockwell Automation.
The two teams collaborated to develop a severely compressed schedule that called for many steps to occur simultaneously. The POD concept was key to making this tight schedule a reality – while the shell of the facility was under construction, the downstream-process PODs were built and commissioned at G-CON's neighboring manufacturing facility.
“We were excited to collaborate with G-CON to develop a truly innovative solution that raises the bar in autonomous clean-room environmental control and process data management,” said Terry Gebert, Vice President & General Manager, Rockwell Automation Global Solutions. “Pushing the limits of our project management, control system design and implementation capabilities is what we do every day.”
The two companies have been working together since the production of G-CON's first prototype POD, designing an unequaled automated modular solution that integrates the life-science expertise of G-CON and its manufacturing capabilities with the project management and control system design and implementation capabilities of Rockwell Automation. As a result, the two teams were ready to meet the aggressive deadline for development and commissioning required for the DARPA project.
“PODs, are autonomous, self-contained clean rooms that provide as much as 768-square-feet of cleanroom space each – complete with their own control, ventilation, fire suppression and data-management systems. The host facility need only provide chilled water, electricity and moderate air conditioning,” said Holtz. “Each POD houses particular unit processes; when combined, they yield an entire process system to purify and deliver biotherapeutics. Each zone operates independently, but is part of the greater structure.”
PODs are equipped with Allen-Bradley® ControlLogix® programmable automation controllers (PACs). The device controls the POD environment – and is an integral part of the POD's autonomous information management package. Data from PODs and upstream processes are managed by LAN based on FactoryTalk® software. As technology evolves, the controller easily adapts – interfacing with new technology that is added, without having to re-validate the core firmware, saving time and money.
The PODs leverage EtherNet/IP™ industrial network to communicate between various process equipment within the POD. EtherNet/IP also enables “clustering” of multiple PODs to efficiently and securely meet the demands of a flexible manufacturing process. EtherNet/IP provides the industrial backbone for POD process control and data management as a single network environment, and allows for seamless integration for “clusters” of PODs. This network topology is essential to implementing a quality Manufacturing Executions System (MES).
G-CON also chose FactoryTalk® VantagePoint® software to access data sources throughout the POD. The application collects and aggregates production data and compiles it into web-based reports to give G-CON real-time data of the process operations. If the temperature is too high, if a fan fails, or if there is an interruption in the purification process, the FactoryTalk applications notify G-CON personnel so that the issue can be addressed immediately. But for G-CON, perhaps the most important aspect that FactoryTalk software provides is data management.
“Quality data is the currency of our business,” Holtz said. “FactoryTalk Historian software automatically collects and archives real-time process data to help us meet regulatory requirements.
“Rockwell Automation leadership has told us that when their employees get up in the morning all they are focused on is the success of their customer's automation projects. This is the type of supplier we needed for the development and long-term support of our venture. Rockwell Automation has specific expertise in the life science space and continues to work with us on challenging projects as our automation partner.”
On March 22, 2011, upon substantial completion of construction of the new facility, POD-bearing trucks backed into the loading docks of G-CON's 145,000-square-foot facility in Bryan, Texas. After unloading the PODs, a team of six workers slid them into place and connected them to the larger facility's water and power system.
In less than one year, the facility was ready to produce vaccines at the rate that DARPA required – within the project's $60 million budget and 21-month operational deadline. In an industry where similar facilities take years and cost hundreds of millions of dollars more to build, this accomplishment is unprecedented.
Today, G-CON is further expanding its reach, marketing and selling PODs globally to biopharmaceutical and pharmaceutical manufacturers for many applications, all which require the comprehensiveness, speed and quality offered by PODs. And, Rockwell Automation continues to support that effort, providing additional products and services while working on the next generation POD, an even smarter and more automated offering.
“As a result of our collaborative relationship and the exciting technology we are developing, Rockwell Automation has invited G-CON to become part of its OEM network and to speak at the Automation Fair® event twice – a huge platform for a small organization like ours. We have also presented together at conferences across the globe,” Holtz said. “They prioritize us. They treat our success as their success, which is something we didn't see from the other companies we considered.”