A redefined focus and smart investment strategies have elevated performance levels and capabilities at Grand River Aseptic Manufacturing.

Driven by an abundance of high-quality lumber and access to the Grand River for transporting huge quantities of the nature resource, Grand Rapids, MI was the epicenter of U.S. furniture manufacturing in the late 1800s. Over time the city transitioned, and now boasts high-tech manufacturing prominence in the aerospace, automotive and healthcare fields. This type of evolution is driven by the ability to recognize and embrace new technologies, as well as their corresponding opportunities. Illustrating this dynamic as well as any company in the region is Grand Rapids Aseptic Manufacturing.

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The company was originally founded in 2008 as a joint venture between Grand Valley University and the Van Andel Institute, serving as a pharmaceutical packing company. The university provided the land while VAI, a bioscience R&D incubator of sorts, established the business. In 2011, a private equity group acquired the company and transitioned it to the contract manufacturer currently known as Grand River Aseptic Manufacturing, or GRAM.

Today, the company has more than 50 employees working in two locations with over 40,000 square feet of cGMP space. Capabilities encompass all stages of clinical development and commercial manufacturing, inspection and packaging. Specific contract production services include liquid and lyophilized vial filling, syringe filling, terminal sterilization, labeling, packaging and kitting. A new, recent addition to GRAM is used for finishing work, while filling and development is still handled at the company’s initial location.

In addition to bringing a transition from packaging to production, the 2011 acquisition included the investment interests of Tom Ross. An initial financial supporter of GRAM, Ross gradually became involved in some day-to-day operations in 2013 before taking on the role of president. He was appointed CEO last year. Ross’ elevation coincides with some the most significant decisions GRAM has made in its brief history, as well as some of its most interesting challenges.

Late-stage developments
Initially, GRAM focused on small-batch, clinical manufacturing covering stages 1-3 in taking customers up to the commercialization stages. “Our focus on quality made us very attractive to those wanting to commercialize but weren’t there yet,” offers Val Dittrich, who handles marketing and business development responsibilities at GRAM. “The problem was that we began to run out of clinical work.”

This slow-down in early-stage business ignited GRAM to pursue opportunities in the commercialization realm of stages 4 and 5. “As we began targeting potential customers and worked the sales pipeline, the need for immediately available, small-run CMO capabilities became clear,” states Ross. “With the consolidation in the CMO market and the acquisition of various manufacturing facilities by big pharma, many customers needed an immediate solution. We had many of these things in place and moved quickly to scale up production capacities.”

“In order to enable growth and attract customers, we had to invest heavily in the facility, equipment, and people,” offers GRAM chief operating office Connie Degen. “This was driven by the long lead times and required validation activities for facility upgrades and equipment, as well as the technical training required for certain staff. Had we not made the up-front investments, it would have proven difficult to attract new business opportunities and build a solid customer base,” she adds.

Accompanying these investments was a slew of implementation challenges focused on handling the increases in production scale. “In early 2014, we doubled the size of our formulation room, expanded our aseptic processing area and added additional WFI capacity to keep up with the demand for larger batch sizes,” recalls Degen. “Since then, we have also gone to three shifts of fill production and are adding automation to our finishing lines,” she states.

Degen places the state-of-the-art clean room and the aseptic filling line that supports projects through all phases of development as some of the most critical investments. “As the client base grew and projects moved toward commercial production, we were then able to invest in areas to support clean room and filling line activities,” she states.

This included increased lab capabilities (chemistry and microbiology), labeling, packaging, inspection and new warehousing space. The later came in the form of the company’s second Grand Rapids facility, which opened late last year.

“However, the single most important investment GRAM has made is in its people,” states Degen.“GRAM’s successes and pivotal moments over the years are a direct result of the talent and expertise of each individual employee and the culture that has been developed.GRAM has invested in talented people and worked to create a strong team environment, which results in each employee’s willingness to step outside their functional areas and help other team members. This investment is what drives company and customer successes.”

Currently, GRAM imprints as many as 20,000 vials and places upwards of 18,000 labels each day. “We never expected to be doing these types of quantities, but the investments and Tom’s leadership has led to our commercial clientele doubling in the last two years,” states Dittrich. She goes on to say that GRAM’s reputation for quality and customer service has led to referrals from larger CMOs who don’t want to handle smaller runs. “We know their company, we know their product and we know what will and will not work. That’s what keeps customers coming back. Based on our history customers know their product is safe here,” she continues.

The company has also invested in improving their processes to mesh with expansion, which led to GRAM becoming DEA-licensed for production and storage of stage 3-5 small molecules. This competitive advantage was realized after urging from a customer that wanted to grow their business relationship with GRAM.

Rolling on the river
“We have no clients in Michigan,” offers Dittrich. “We’re one of the few CMOs in the Midwest, so we’re not exactly located in a prominent life sciences geography. It just proves that you don’t have to be in a traditional hub to grow and attract new business.” Looking forward, Ross will rely on a number of key strategies to help GRAM continue bringing new contract manufacturing work to Grand Rapids.

“Managing growth in a fast-growing company is challenging,” offers Ross. “Anticipating resource needs and finding highly skilled talent to help achieve aggressive growth targets remain a key focus.” Degen adds, “We are routinely reviewing operations in relation to individual projects with a focus on continuous improvement.” This continuous improvement approach, and the elements of quality inherent to it, also pertain to the way GRAM is growing its workforce.

“Dedication to quality begins at the interview process,” states Degen. “Prospective hires are evaluated for their work ethic and understanding of the critical nature of our manufacturing. During the on-boarding process, there is significant emphasis placed on all aspects of quality, including documentation and good manufacturing practices.

“For the aseptic manufacturing group, training is interactive and frequent. Every employee is instructed on the importance of their role to the overall quality of the product, and learns to see each unit produced as one that may be injected into a loved one. Company management maintains and reinforces this commitment to quality as the most important aspect of our work,” she adds.

In continuing with GRAM’s ongoing commitment to both quality and growth, Ross points to the following as potential opportunities and areas of investment:

• The price and time paybacks of single-use systems for commercial production.
• Capitalizing on growth in markets such as injectables, personal dosage, pre-filled syringes and kitting for finished product.
• Possibly adding another clean room to increase production quantities.
• Merger and acquisition activity has led to some bigger companies eliminating offerings that are not as profitable. Some of these could be opportunities for GRAM.

“Over the next few years the goal is to maintain a trend of sustained, profitable growth while continuing to round out our capabilities and service offerings,” states Ross. “Before considering expansion into new sectors, we want to continue to solidify our reputation and track record.” Just as the city it calls home, GRAM seems poised to continue evolving and preparing for the next phase of growth.