Project Farma’s Contributing Authors
Phil Massey and Tony Prince

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Due to technological advancements in the biopharmaceutical industry over the last decade, medical breakthroughs are being approved at an exponential rate. With such rapid market growth, demand has increased for flexible alternatives to centralized manufacturing. Having a full-scale GMP facility for each new therapy is implausible yet most facilities are not equipped with the flexibility required to manufacture multiple products. Drug developers and the Contract and Development Manufacturing Organizations (CDMOs) that serve them have experienced a significant bottleneck to getting therapies through the clinical process and ultimately to patients. 

In addition, many production processes, specifically for cell and gene therapies, are unique to the disease they are treating and therefore cannot be produced through traditional manufacturing methods. These factors combined with an urgency to bring the drugs to market as soon as possible, has put pressure on companies and industry experts to find innovative ways to produce drugs. 

We have seen our customers employ various approaches to solving these issues. Some have been successful, some not. One approach that we have had first-hand experience with and that has worked well in a number of projects is the use of G-CON’s POD technology. Companies like G-CON are now offering flexible, pre-fabricated modular cleanrooms that are built offsite and delivered as a product to the customer site. These prefabricated mobile cleanrooms offer several key advantages that are well- known to the industry: 

• Flexibility in the process and production 
• The ability to scale without interruption 
• Reduced product timelines and cost 
• Portable platform for easy placement and rapid deployment 
• Seamless integration into “gray space” or non-controlled area

We have worked with G-CON on several projects and we have seen additional benefits to our clients as well. We have seen the following attributes and comment on the usefulness below: 

• Consistent Bill of Materials using high quality products and qualified suppliers 
• SOP driven production processes 
• Fully documented turnover packages and factory acceptance & site acceptance tests 
• Leverageable, repeatable testing protocols 
• Controlled manufacturing environments reducing onsite quality and logistics issues 

Flexibility and Multi-Product Processing 
PODs are easily customizable because they utilize modular equipment, allowing manufacturers the flexibility to re-purpose each POD to their specific needs. Each individual POD acts as a building-block towards the assembly / configuration of a larger POD cluster or group. PODs can be customized down to the individual level to fit the design needs and process requirements of the group. Overall, POD technology can be a solution for every product development stage as it can be used in a single process step or as a total process containment solution. This is key for cell and gene therapy manufacturers as the demand for their therapies will be nonlinear over time. At first, there will be a high demand for the therapy, but the need going forward will level off and may even decrease as the existing population of patients are treated. Utilizing POD technology gives manufacturers the flexibility to re-purpose each POD to a new therapy or process as the demand for their products evolve over time. 

Reduced Production Costs and Fixed Budget 
The planning, construction, and qualification of a full-scale GMP facility is costly and can take years to finish. Often, early stage or mid-sized companies do not have the need for, or the capital to invest in a GMP facility. Taking advantage of POD technology gives these companies the option to work with a limited budget by investing in several small-scale upstream/downstream PODs that fit their unique needs. Once the product is ready to be scaled up, the initial design can then be duplicated as demand grows, keeping the manufacturing costs stable and predictable throughout production. Deploying prefabricated POD technology significantly cuts down on costs, time to production, and opportunity loss. Furthermore, because PODs are easy to decontaminate and restructure, investing in a POD is investing in an asset that can be repurposed to lease or sell to another manufacturer. 

Streamlined Commissioning, Qualification, and Validation Processes 
POD technology benefits from employing repeatable products, processes, and protocols to save time and money as validation efforts become pre-planned, pre-packaged and predictable. G-CON, for example, uses templates and testing schedules to better receive customer validation teams for Factory Acceptance Testing. Carefully planned turnover checklists and procedures allow for a seamless transition to Site Acceptance Testing after POD delivery. Consistent management during CQV affords customers a streamlined validation package that is always easily incorporated into the overall site validation and readiness strategy. The turnkey nature GCON’s package provides smaller companies and facilities the unique POD technology benefits from employing repeatable products, processes, and protocols to save time and money as validation efforts become pre-planned, pre-packaged and predictable. G-CON, for example, uses templates and testing schedules to better receive customer validation teams for Factory Acceptance Testing. Carefully planned turnover checklists and procedures allow for a seamless transition to Site Acceptance Testing after POD delivery. Consistent management during CQV affords customers a streamlined validation package that is always easily incorporated into the overall site validation and readiness strategy. The turnkey nature GCON’s package provides smaller companies and facilities the unique opportunity to establish cleanrooms without the need for dedicated SME involvement. “G-CON has focused on ensuring that FAT is comprehensive for every project. This both decreases project timelines, by requiring less onsite testing, as well as catches any possible issues at the factory, where they can be addressed quickly and retested at SAT,” stated Tom Ronat, G-CON’s Director of Quality. 

Scaling Without Interruption 
POD technology helps to solve the industry’s growing bottleneck by providing alternatives to outsourcing product production without having to build new facilities. Companies now have the flexibility to create faster and predictable product scheduling without limiting themselves to CDMO’s production capacity and scheduling. Rather than constructing and qualifying their own facility, manufacturers can now lease humidity and temperature controlled warehouses to house their manufacturing PODs. 

The ability to customize and prefabricate PODs allows for quick construction and installation of the facility without the opportunity loss that typically occurs between approval and production. The offsite assembly of PODs allows for parallel-path, independent completion before transport and installation. Each POD is designed with its own failsafe HVAC system that requires few connections to the host facility, because typical HVAC mezzanines are not required, a large portion of the facility design process can be removed. The PODs integrate seamlessly with facility utilities. As the PODs are a sub-system within the warehouse environment, facility planners are afforded additional flexibility when determining site location. This flexibility translates to a broader selection for acquisition or easier construction process as applicable. 

POD technology’s inherent flexibility affords small to midsize companies in late phase clinical trials the opportunity to scale processes in reduced time and for a fraction of the cost. When expanding, additional pods can be added to existing structures to meet increasing demand and deliver life-changing therapies to patients in need.