Expansion across its network will mean hundreds of new employees in Cincinnati, increased ability to get complex medicines to patients and more.
Expecting the recent increase in drug product demand to continue, Resilience is taking steps to meet that demand and fulfill patient needs, according to Syed Husain, chief commercial officer at the company. Those steps include expanding the San Diego-based biomanufacturing organization’s clinical and commercial drug product manufacturing capabilities across its network, primarily at its Cincinnati and Research Triangle Park, North Carolina, sites.
Resilience’s preclinical, clinical and commercial cGMP manufacturing network can help withstand unforeseen difficulties like capacity constraints and raw material supply chain shortages, and the strategic expansions will address the growing demands in the drug product space, Husain told BioSpace.
Increasing its drug product capabilities is the latest milestone for Resilience, a company that’s striving to set itself apart from other contract development and manufacturing organizations. In its work to revolutionize the CDMO space, it has focused on the foundation of biomanufacturing, prioritized manufacturing technology development and redefined what partnership means.
Since its inception, Resilience has acquired manufacturing and development facilities and upgraded its digital, quality and capacity capabilities at its sites across North America. The latest expansions in Cincinnati and Research Triangle Park will help the company best serve its partners, broaden patients’ access to complex medicines and bring hundreds of new employees to Ohio.
Meeting Increased Drug Product Demand
Announced in February, Resilience’s latest expansion includes plans to put at least $225 million into increasing its Cincinnati facility’s drug product capacity. It also involves investing in its Research Triangle Park site to add small to midscale fill/finish capabilities. As a result of the increased capacity and capabilities there and across its manufacturing network, leadership expects the company to provide over 200 million units to its partners by 2025. Those units will support multiple modalities and therapeutic indications.
The expansion is also important to the company’s development, Husain noted. “The combination of robust market growth, rising outsourcing trends and high-value opportunities makes the drug product business an attractive area.”
He shared that according to internal analysis, market demand will continue to outpace drug product outsourcing supply for the next decade at a 21% compound annual growth rate based on three key factors:
- Strong, stable and predictable growth of clinical drug product demand across complex therapies such as biologics, vaccines and gene therapy modalities.
- The use of GLP-1 receptor agonists likely quadrupling over the next decade, absorbing clinical and commercial demand to treat patients living with type 2 diabetes, obesity or both.
- A shortage of experienced outsourcing providers that know how to work with vials, prefilled syringes (PFS) and auto-injectors through the full drug development lifecycle.
As part of the growth at its Research Triangle Park facility, where it has drug substance and drug product experience in support of gene therapy medicines, Resilience will install a new state-of-the-art Bausch & Strobel Isolator filler to support vials and PFS in a fully segregated 45,000-square-foot facility.
Making a Significant Investment in Cincinnati
The most significant portion of its recently announced expansion will happen at Resilience’s Cincinnati facility, a 580,000-square-foot center for fill/finish and device assembly and packaging. Sitting on 44 acres and featuring a 100,000-square-foot warehouse, the site was previously owned by AstraZeneca. Resilience acquired it in January 2023.
The Cincinnati facility’s key competency areas include:
- Aseptic processing and fill/finish.
- Cold chain and ambient storage capabilities.
- Automated inspection, device assembly, labeling and packaging for vials, syringes and cartridges.
This FDA-licensed site is capable of commercial drug product manufacturing and device assembly, labeling and packaging of various small and large molecules, according to Josh Matson, the Cincinnati facility’s general manager and site head.
Expansion will benefit the location’s drug product capacity in multiple ways, allowing Resilience to provide needed capacity to partners and get patients the medicines they need. For example, it will add a fourth high-speed fill line for prefilled syringes and expand from three to six device assembly and packaging suites by 2025.
Matson told BioSpace the Resilience Cincinnati expansion is important in the sterile injectable and device assembly space because there’s a capacity shortage today.
“The clients that we’ve been working with are clients that need capacity, and they need it quick, and our experience grows every day with the exciting products we manufacture and supply commercially for our pharma partners,” he said. He added that with the expansion, Cincinnati can meet an immediate need not only for partners but also for patients. “They can’t always get this medicine when they go to the pharmacy today. So, every unit we make helps with that unmet need for patients.”
Building Up the Workforce
To support the Cincinnati site’s growth, Resilience will hire over 400 people at that location over the next 2.5 years. There are about 750 employed there now, up from roughly 450 last summer. Mara Strandlund, chief people officer at Resilience, told BioSpace the 400 additions will fill a variety of roles, primarily in manufacturing and quality. She noted they’re trying to add 90 full-time positions now.
Strandlund views the Cincinnati facility as a fascinating facility to work in because of its technology.
“Some of the robotics, some of the high-speed fill lines, it really brings an interesting mix of how we want to bring technology into the workplace as we continue to evolve as a company,” she said.
Resilience is also hiring in Florida, North Carolina, Pennsylvania and Toronto.
According to Strandlund, there are multiple reasons the company is attractive to biopharma professionals.
“I always think scaling’s fun if you want that growth environment,” she said. “But more importantly, we’re a young company, and when you join a young company, you have the ability to influence in a different way. The policies haven’t been set for 30 years.”
Strandlund also cited the breadth of fields Resilience has across its locations as a reason prospective employees might be interested.
“Drug product is in Cincinnati, but the company also develops and manufactures drug substance and covers multiple modalities including biologics, vaccines, nucleic acids and cell and gene therapies across our network,” she said. “So, from a scientific perspective, people can get involved in different areas in some very unique ways.”
