Meet Grand River Aseptic Manufacturing: 2021 Facility of the Year Awards Winner for Operational Agility: COVID-19 Impact

This is a very special category that the FOYA Judges deemed important during such an unprecedented year, not only because of the impact the COVID-19 pandemic had on the pharmaceutical industry but because of the impact it had on the entire world. Facility of the Year Awards (FOYA) Operational Agility: COVID-19 Impact Category winners are receiving special recognition for their operational agility to make progress and/or impact the efforts for therapies and vaccines to combat the pandemic.

Grand River Aseptic Manufacturing is one of two companies that was awarded a FOYA in Operational Agility: COVID-19 Impact. Gilead also won an award in this category.

Project: Large-Scale-Fill-Finish Facility

This project was selected for creating a facility that was able to support a pressing need of the day, response to the COVID-19 pandemic. The judging committee recognized that agility as an engineering value driver is getting increasingly important, and in a year where the promise of therapies and vaccines provided much-needed hope for the broader community, Grand River Aseptic Manufacturing’s sense of urgency, commitment to creative project execution, and collaboration are commendable. The facility design reflects the flexibility, the speed, and the operational agility that ISPE believes are critical to continue driving our collective value.

FOYA Judges

A Perfect Time for Expansion

As demand for their services grew, Grand River Aseptic Manufacturing (GRAM) knew they needed a large-scale fill-finish facility. As part of the new facility, GRAM planned to offer general pharmaceutical liquid-filling, lyophilization, and straight liquid filling/terminal sterilization on a larger scale than previously available. They also wanted to offer contained formulation suites to support their multi-product facility design.

When GRAM begin planning the project in 2016, no one had ever heard of the COVID-19 virus, but GRAM’s timing and the choices they made throughout the project meant that they were in the perfect position to help during a pandemic.

The new facility was built with future expansion in mind and includes:

• State-of-the-art isolator technology
• Two Grade C formulation suites
• Filling suites
• Cold and frozen storage
• QA Laboratory
• Customer viewing rooms
• Future capacity for new technologies

GRAM wanted to handpick the best equipment from various vendors which would play nicely together. They started researching equipment years before they were ready to purchase including visiting overseas Original Equipment Manufacturers to examine their processes, assembly floors, and equipment. Once equipment was selected, GRAM worked with a design and construction firm to create their space around the central core of aseptic manufacturing equipment.

GRAM chose the site of their new facility because of its proximity to their existing facilities and a major university and for its ease of accessibility in the downtown area, but the location ended up being the biggest challenge to the project. Since the site had previously been used as a laundry chemical producer, there were toxic chemicals in the ground, and it had to undergo intense soil remediation. The ground was also filled with gypsum and had to be stabilized before construction could begin. The soil stabilization process required huge equipment which took up most of the construction site but in order to stay on-time the foundation footings were prefabricated off site. Once the ground was ready, a crane brought them in and they were set in a matter of hours, eliminating weeks off the schedule.

On-site, there was constant collaboration between management, design teams, construction crews, and outside contractors. Off-site contractors collaborated with design and construction teams using 3-D modeling which meant that almost 90% of the mechanical systems were able to be prefabricated. These time-saving solutions paid off. As news of the COVID-19 pandemic began to spread in early 2020, GRAM went into overdrive and speed up work to get operations fully functional as soon as possible.

“In May 2020, we received a BARDA questionnaire asking if we could be part of the response to the pandemic,” said John Wichelt, Vice President, Client Pharmaceutical Services, GRAM. “The one problem was we weren’t scheduled to be operational until October. But the entire team leapt into action so that we could meet BARDA’s schedule.”

GRAM conducted a new security audit for vaccine-related activities and began onboarding new hires. They started the qualification process in parallel with final construction and worked to successfully bring the facility up to sterility standards. They hired additional validation consultants and re-deployed several of their own employees to speed up validation efforts. Team members worked 60 to 90 hours a week to get ahead of the original schedule.

Because of the smart choices GRAM had made throughout the planning and construction phases and thanks to the team working tireless together to meet the new goals, GRAM was able to run its first batch of a COVID-19 vaccine candidate six weeks ahead of their original operational schedule.

“Bringing a new facility online is stressful under normal circumstances,” said Wichelt. “But doing it during a pandemic with less staff and higher stakes required almost superhuman effort and laser focus on the enormous social impact the facility would offer. GRAM’s capacity not only supports the U.S. government’s Operation Warp Speed efforts and the COVID-19 pandemic response, but also increases U.S. preparedness for future public health emergencies.”

Nominate Your Facility for the 2022 FOYA Program!

Apply for a chance to join this prestigious list of innovative game-changers and let ISPE honor your organization as a 2022 FOYA program winner. Applications must be submitted by 19 November 2021.

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