Achieving Operational Excellence in Today’s Fast-Paced Sterile Fill-Finish Market 

Charged with delivering advanced therapeutics in today’s fast-paced market, as a CDMO, agility is everything. From an operational standpoint, CDMOs must have the necessary infrastructure to successfully support a wide range of products. This begins with a strong foundation of both advanced capabilities and highly trained teams. Denis Johnson, GRAM’s CEO shares insight leveraging his extensive experience in sterile fill-finish and running CDMO facilities, on anticipating trends, addressing challenges, and providing solutions, as well as flexibility that enables CDMOs to adapt to market changes.

Contract Pharma: Please share a brief background on your experience running CDMO facilities.

Denis Johnson: As a leader with over 25 years of experience in GMP-regulated environments spanning medical devices and pharmaceuticals, I’ve built my career on a foundation of operational excellence and a deep commitment to improving patient outcomes. Over the past six years, I’ve focused on the CDMO space, where I’ve found immense satisfaction in partnering with leading pharmaceutical companies to bring transformative therapies to market.

I’m especially passionate about the sterile fill and biologics manufacturing sector, which I’ve specialized in for the last five years. It’s one of the most complex and rewarding areas in our industry.

Throughout my career, I’ve led operations that have generated up to $850 million in revenue and managed teams of over 3,000 employees. I take pride in building resilient, high-performing organizations that are agile, quality-driven, and deeply aligned with the needs of patients and partners alike.

My mission is simple: to lead with purpose, empower teams to excel, and deliver solutions that make a meaningful difference in the lives of people around the world.

Contract Pharma: What are some key challenges clients face in today’s sterile fill-finish market and how is GRAM able to address them?

Denis Johnson: Three key opportunities stand out to me in today’s pharmaceutical manufacturing landscape: the ongoing evolution of quality expectations, the need for expanded U.S.-based sterile fill capacity, and the strategic implications of tariffs.

Sterile filling is essential to patient safety and therapeutic success. As isolator technology has advanced, so too have the standards for automation and control. The expectations today are significantly higher than they were a decade ago—and that’s a good thing. It challenges us to continuously improve, innovate, and stay ahead of the curve. Every leap in technology enhances our ability to deliver for patients with greater precision and reliability.

To maintain and grow capacity in this space, we must invest not only in cutting-edge equipment but also in the skilled professionals who operate it. Equipment alone doesn’t drive success—people do. While I see substantial investment in infrastructure across the industry, there’s a clear gap in the availability of highly trained teams. That’s where GRAM stands out. We’ve built a strong foundation of both advanced capabilities and experienced talent, positioning us to lead in product launches and tech transfer with speed and confidence.

Finally, the impact of tariffs has accelerated interest in reshoring, and we’re leaning into that momentum. GRAM is actively expanding our footprint at our Grand Rapids, Michigan campus to meet the growing demand for domestic manufacturing. We’re proud to be a trusted partner for pharmaceutical companies looking to strengthen their U.S. supply chain presence.

Contract Pharma: What types of products are you seeing increased demand for in the sterile fill-finish space?

Denis Johnson: One of the most significant shifts we’re seeing in the industry today is the surge in GLP-1 products—driving the highest volume expansion since the COVID pandemic. It’s a remarkable transformation, fueled by a concentrated set of product codes, and it’s reshaping capacity demands across the board.

At the same time, there’s an equally important movement toward targeted therapies for rare and orphan diseases. This trend is generating a diverse portfolio of small to medium-volume product lines, each with the potential to make a profound impact on individual patient populations. It’s an exciting evolution that reflects the growing precision and personalization in modern medicine.

From an operational standpoint, high-volume products challenge our equipment capacity, while the proliferation of smaller, specialized molecules puts pressure on our technical expertise and team agility. Success in this environment requires not only state-of-the-art infrastructure but also a highly skilled workforce capable of managing complex launches and rapid product transitions.

At GRAM, we’re embracing both sides of this shift. We’ve invested in scalable technology and built a team with the depth and versatility to meet the demands of high-volume production and high-mix innovation. It’s a powerful combination that positions us to lead in this new era of pharmaceutical manufacturing.

Contract Pharma: What equipment/capabilities are needed to accommodate the increasing complexity of modern therapeutics?

Denis Johnson: We’re seeing a strong and growing demand for fully automated isolator filling systems—and it’s a trend I’m excited about. These advanced technologies are perfectly suited for the production of specialized small-batch biologics.

Ensuring product integrity and patient safety is non-negotiable, and I believe our industry is rising to meet that challenge with smarter, more precise solutions.

Equally important is the role of real-time monitoring and data analytics. These tools are transforming how we manage quality control and optimize production. By leveraging data, we’re not just reacting—we’re proactively improving processes, anticipating issues, and driving continuous innovation.

At GRAM, we’re embracing these advancements to stay ahead of the curve and deliver exceptional value to our partners and the patients they serve.

Contract Pharma: What role does technology play in running CDMO facilities?

Denis Johnson: Automation is transforming pharmaceutical manufacturing—and I see it as a powerful enabler of precision, consistency, and scalability. By integrating robotic systems into our operations, we’re able to execute repetitive tasks like filling, labeling, and packaging with remarkable accuracy and efficiency. This not only minimizes human error but also drives higher throughput and reliability across the board.

As a CDMO, agility is everything. Innovative manufacturing technologies allow us to respond quickly to evolving client needs, whether it’s scaling production, accelerating timelines, or adapting to new therapeutic formats. This flexibility is a key differentiator in today’s fast-paced market.

Of course, with greater technology integration comes increased responsibility. Cybersecurity is no longer optional—it’s foundational. Protecting sensitive data and intellectual property is critical to maintaining trust and ensuring the integrity of our operations. At GRAM, we’re committed to implementing robust security protocols that safeguard our systems while enabling innovation to flourish.

Contract Pharma: How does GRAM provide the flexibility needed to adapt to market changes?

Denis Johnson: At GRAM, we’ve built our sterile filling operations around versatility, precision, and scale. Our five sterile filling machines equipped with advanced isolator technology are designed to handle a broad spectrum of formats, from liquid and lyophilized vials to syringes and cartridges. Whether it’s small or large volumes, low-speed or high-speed filling, we have the infrastructure to support a wide range of product needs while staying true to our core strength: sterile fill excellence.

Equally important is the collaborative ecosystem we’ve cultivated. We’ve established strategic partnerships with drug-device delivery companies, built deep relationships with equipment manufacturers, and maintained strong ties with component suppliers. These alliances give us the agility to adapt quickly to market shifts and ensure continuity in our mission to serve patients.

Together with our partners, we’ve created a resilient and responsive network—one that allows us to stay focused on what matters most: delivering safe, high-quality therapies to the people who need them.

Contract Pharma: What trends do you anticipate will further drive growth in the sterile fill-finish space?

Denis Johnson: The pace of innovation in the pharmaceutical industry continues to inspire me. It’s accelerating in ways that are reshaping how we think about development, launch, and long-term sustainability. I believe this momentum will only grow stronger—and at GRAM, we’re committed to keeping pace with it.

Innovation today is a balance: speed is essential to get products into clinical trials quickly, but long-term success depends on achieving competitive economics post-launch. Our partners value both. They want to move fast without compromising scalability or cost-efficiency down the line—and we’re built to deliver exactly that.

At GRAM, we’ve assembled a team with deep technical expertise from years of successful product launches. We’ve paired that experience with a versatile infrastructure that includes five filling lines and the capacity to add four more. Our mix of high-volume and flexible-volume equipment allows us to support rapid development while ensuring sustainable economics as products mature.

We’re proud to be a trusted partner in this evolving landscape—and we’re ready to support the continued growth and innovation that define our industry.