Lab Manager first profiled the Grand River Aseptic Manufacturing (GRAM), Large-Scale Filling Facility in Grand Rapids, MI, in November 2020. https://www.labmanager.com/lab-design-and-furnishings/project-profile-grand-river-aseptic-manufacturing-facility-24266 This building has helped accelerate the domestic manufacturing of a COVID-19 countermeasure. Lab Manager spoke with Katelyn Deckert, laboratory planner and architect at CRB, and Ian VanOeveren, senior manager, analytical services, on behalf of GRAM, about the updates to this lab facility and how the COVID pandemic has affected its growth and day-to-day operations.
Q: What has changed since June 2020, particularly regarding the lab facilities?
A: The Butterworth Analytical Research and Development (ARD) laboratory went from design concept, to a fully outfitted laboratory with state-of-the-art equipment and testing capabilities.
Q: How has the COVID pandemic affected this facility? Have occupancy levels been reduced, has access been limited, have labs been expanded, etc.?
A: The services provided by Grand River Aseptic Manufacturing (GRAM) have always been considered essential, and as part of Operation Warp Speed it was more important than ever that we deliver on our commitments to our clients, the community, and our nation. Even as timelines were being shortened and priorities were shifting, our staff was required to limit occupancy and work remote when possible. While it was difficult to adjust to this new landscape and meet our obligations, we adapted quickly. The analytical staff was able to manage the commissioning activities of the new ARD laboratory, while simultaneously performing the tech transfer to onboard the Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, COVID-19 vaccine into the facility.
The careful selection of the equipment and the thorough planning during the lab design phase put GRAM in a unique position to support our client’s needs without modifying our original plans. Thus, the ARD laboratory was unchanged as a result of COVID-19, with exception of how quickly the onboarding process took place.
Q: What kind of feedback have researchers offered in the past year about this facility?
A: Due to travel restrictions throughout COVID, there has been a limited number of external site visitors. The feedback that has been received so far is very positive. Our team and our clients are excited for the potential growth and opportunities this new lab presents.
Q: How flexible has the lab design been since 2020? Has the setup changed at all? Has there been a change in equipment, casework, furniture, etc., in the past year?
A: While the original plans for the ARD laboratory have not changed in terms of layout and the type of equipment that was acquired, the pace of onboarding and qualification has accelerated to meet the demands of the industry. There is more urgency than ever to meet timelines and get our products to the marketplace. The acquisition of new technologies such as Ultra High-Performance Liquid Chromatography (UPLC) and SoloVPE Slope Spectroscopy instruments at GRAM will allow for a wider range of experiments and types of products that GRAM can evaluate. The use of these instruments will reduce turnaround times and decrease the amount of solvents needed to perform sample analyses.
The design of the ARD laboratory in terms of layout and casework had adaptability and flexibility in mind from its inception. These are some of the design features that facilitate efficiency and adaptability with minimal rework as the needs of the lab change:
- Open lab design in a modular layout allows for standard utility runs and circulation/flow efficiency.
- The layout of the benches is set perpendicular to the exterior wall to maximize access to daylight and views.
- All bench islands are moveable and connected to overhead services for plug-and-play capability.
- Benches also feature adjustable height worktops and shelving, to help with ergonomics as well as accommodating a variety of equipment.
- Benches can be unplugged and removed to allow for larger floor mounted equipment or robotics to be swapped in.
- A special split bench module with exhaust capabilities is set up for analytical equipment, allowing easy access for service.
- Fixed casework (such as sinks and chemical fume hoods) that requires hard connections to building infrastructure are kept at the perimeter of the room to maximize flexibility in the open space.
Q: Now that there is a "light at the end of the tunnel" regarding the COVID crisis and its vaccines, what is going on at the GRAM facility? If things are winding down, what is next? Has the design or layout of the lab changed as a result?
A: While COVID is not yet behind us, it has certainly been a welcomed change to get back into a more routine office setting. Our staff is very excited to be transitioning back to the office and begin testing in this new lab space. Having brought this new laboratory online, the analytical team is eager to get back on the bench. With their shared motivation, high education, and combined breadth of industry experience, they are ready to put all that on display to support new project work.
While the overall design concepts and layout of the ARD laboratory have not changed, this new space allows for a more streamlined approach for analytical services. This new space will allow the GRAM team to be more efficient and extend our service offerings to additional research and development projects.
Q: What does the future hold for the labs?
A: As GRAM’s client base and product portfolio continues to expand, the types of instrumentation and technology that GRAM utilizes will continue to expand as well to meet the needs of clients. As a key player in the CDMO space, we must adapt as the pharmaceutical industry advances to provide the best support to our clients. We have always prided ourselves in our ability to say yes when others cannot. Every new project, innovation, and challenge presents an opportunity to grow and each success makes us better prepared for the next. In order to maintain this ability, lab expansion is on the horizon in the not-so-distant future. It’s an exciting time at GRAM and we are looking forward to seeing what the next chapter has in store for us.