Prodigy Partners with Native American-Owned Cannabis Company to Establish 1st Fully GMP-Compliant Pharma Cannabis Facility in US

ProX cannabis extraction system.

Image: Prodigy Processing Solutions

With the anticipated rescheduling of marijuana to a Schedule III controlled substance by the US Drug Enforcement Administration, Refined Processes LLC, a Native American-owned cannabis oil processing company in California, recognized the potential for growth and the need for stringent regulatory compliance. The decision was made to develop a state-of-the-art, fully FDA GMP-compliant cannabis extraction lab facility to facilitate opportunities in the pharmaceutical sector.  Refined Processes has collaborated with Prodigy Processing Solutions, an innovator in GMP-compliant cannabis extraction technology, to develop a lab facility that not only meets but sets new standards for quality and compliance in the cannabis industry, with a focus on innovative extraction solutions and regulatory adherence.

Lab Design News spoke with Marc Beginin, founder and CEO of Prodigy Processing Solutions, and Aaron Thomas, founder and CEO of Refined Processes, about this lab facility and its implications on cannabis extraction. 

Q: When and how was the decision to develop this lab facility reached? 

AT: My professional relationship with Marc Beginin and Prodigy Processing Solutions spans over a decade and has been incredibly impactful. As an attorney and extraction industry expert, Marc has continually brought a wealth of knowledge and innovative extraction solutions to the table, which significantly enhanced my processing operations."

Several months ago, Marc and I had an in-depth conversation about the likely DEA rescheduling of cannabis and the significant opportunities it would open up in the pharmaceutical sector. Recognizing the potential for growth and expansion, we decided to proactively develop a fully FDA GMP-compliant cannabis extraction lab facility.

MB: Some time ago, I informed Aaron about the anticipated DEA rescheduling of cannabis and the vast opportunities it would present in the pharmaceutical sector. Seeing the potential for growth and the need to meet stringent regulatory standards, Aaron decided to proactively upgrade his facility. Together, we're making sure his facility is top-notch in terms of FDA pharma compliance and quality, setting a new standard in the industry.

Q: Did it replace an existing facility, or was it developed to meet the need for a new facility?

AT: Initially, we were operating on the Santa Ysabel Reservation, which provided a solid foundation for our existing operations. However, as we prepared for the anticipated DEA rescheduling and the expansion of our market reach, it became evident that we needed a location that offered enhanced logistical advantages and scalability.

Palm Springs emerged as the ideal choice due to its superior infrastructure, accessibility to major transportation routes, and proximity to key markets. This move not only allows us to streamline our supply chain but also positions us closer to our distribution partners and compounding pharmacies.

The site was already licensed under California law and had existing infrastructure that we could build on. This not only facilitated a smoother transition but also allowed us to expedite the upgrade process to meet FDA cGMP and EU GMP standards.

Q: How can a cannabis extraction facility find vendors (architects, engineers, lab planners, equipment/furniture vendors, etc.) who specialize in this type of lab? Do you look for firms with a specific certification or portfolio, do you use word of mouth from similar labs in your industry, do you do a search and base your decision on interviews, etc.?

MB: When selecting firms to work with, especially for something as critical as a cannabis extraction lab, one needs to employ a multi-faceted approach, including prioritizing firms with specific experience and a strong portfolio that demonstrates their capability to meet stringent regulatory standards, such as GMP compliance.

Finding specialized vendors for a cannabis extraction facility can be a daunting task, but that's precisely where Prodigy excels. Prodigy brings a comprehensive one-stop-shop of professionals to the table, including architects, engineers, and lab planners, providing all the expertise and services needed for developing a state-of-the-art extraction lab, all tailored to meet GMP compliance standards.

Prodigy specializes in providing comprehensive services for cannabis extraction facilities. Our extensive network includes trusted architects, engineers, lab planners, and equipment vendors who understand the unique requirements of the cannabis industry. We only work with vendors who meet the highest standards for quality and compliance.

 AT: Having built ten successful cannabis extraction lab operations from scratch, I know firsthand the challenges of finding reliable design and development partners. Prodigy transformed the experience into a seamless, turnkey solution with its network of elite architects, engineers, and lab planners who specialize in cannabis facility planning and lab design.

Q:  What kind of safety standards do cannabis extraction facilities have? How might these differ from something like a university life sciences lab or a pharmaceutical lab?

MB: The safety standards for cannabis extraction labs are fundamentally the same as those for university life sciences labs or pharmaceutical labs, encompassing both operator and consumer safety. However, the larger scale and specific needs of cannabis labs introduce some additional requirements.

For operator safety, cannabis extraction labs handle larger volumes of material and more intensive processing activities compared to university labs. This necessitates more robust ventilation systems to manage vapors and gases, as well as enhanced fire safety measures due to the use of flammable and combustible solvents. Compliance with classifications like C1D1 and C1D2 under the National Electrical Code (NEC) is essential. These labs must have explosion-proof equipment, comprehensive fire suppression systems, and detailed emergency response plans. Extensive training on safety protocols and proper use of personal protective equipment (PPE) is crucial to ensure operator safety.

Regarding consumer safety, cannabis extraction labs must adhere to stringent Good Manufacturing Practices (GMP) to ensure products are consistently produced and controlled according to quality standards. This involves maintaining clean and hygienic manufacturing areas, preventing cross-contamination, and implementing robust quality control and testing procedures. Because these labs produce consumable products, there is a heightened focus on ensuring product consistency and safety, which often requires more extensive quality assurance processes than those found in university labs, which are geared toward research activities.

Q: What kinds of sustainability initiatives have been included in the design plan? Are these specific to cannabis extraction facilities, or do they align with other kinds of labs?

MB: Sustainability is a key focus in Prodigy's product development, and we're excited to be testing a prototype of a revolutionary chilling system, which is groundbreaking as it uses almost no electricity. It's designed to work with all cannabis extraction systems, but it also has the potential for great utility across various industries.

While we can't share the details just yet, I can say that it will be a significant step forward in energy-efficient lab operations for both sustainability and ROI. Stay tuned for more information once we're ready to unveil it to the world.

Q: Is there anything particularly unique or groundbreaking about your facility or the design plan?

MB: There are several unique and groundbreaking aspects of the Refined Processes facility and design plan. One of the standout features is the ProX extraction system, which is unmatched in terms of speed and return on investment (ROI). The ProX operates at ultra-cold temperatures, rated for an astounding -300F, which significantly enhances the efficiency, purity and potency quality of the final product while eliminating the need for winterization, thereby saving valuable time and labor.

Additionally, Aaron's facility will be the first pharmaceutical FDA cGMP-compliant cannabis extraction lab in the nation. This compliance is a significant milestone, setting a new benchmark for quality and safety in the cannabis industry. Our commitment to these standards demonstrates our dedication to leading the way in both innovation and regulatory adherence.

Q: What sorts of challenges did you encounter during the design/build process, and how did you overcome them?

MB: One of the primary challenges we encounter during the design/build process is threading the needle between creating an efficient workflow and meeting stringent regulatory requirements. Architectural design plays a crucial role, as we needed to ensure that the facility's layout optimized operational efficiency while adhering to all safety and compliance standards.

AT: We collaborated closely with Prodigy's architects and engineers to develop a state-of-the-art facility that balances both needs effectively, ensuring seamless operations and full regulatory compliance.

Q: How was the lab manager/researcher's input incorporated into this design plan? Did you meet with lab users in the kickoff meetings or rely on lab managers to collect their staff members' input to relay to you?

MB: The input from lab managers and operators is integral to all lab planning. From the very beginning, we engaged with Refined Processes' key stakeholders to gather insights on their operational needs and challenges. Their firsthand experience and practical knowledge were crucial in shaping a facility that not only meets regulatory standards but also supports efficient and effective daily operations. This collaborative approach is essential in creating a state-of-the-art facility tailored to the unique needs of each extraction lab.

Q: If a similar facility or program were to look at your facility for inspiration, what do you think they would take away as an example of what they should also implement in their own lab?

MB: They would see the importance of balancing optimized workflow with regulatory compliance. Prodigy designs facilities to maximize operational efficiency while meeting FDA cGMP standards. They would also recognize the value of integrating advanced technology, like our ultra-cold ProX extraction system, which not only enhances product quality but also streamlines the extraction process. Their final takeaway would be the importance of collaborative design, incorporating input from lab managers and extraction technicians to ensure the facility meets practical operational needs. This holistic approach results in a state-of-the-art GMP-compliant lab supporting optimal useability and maximum profitability.