Pharmaceutics International Inc. (Pii) is a contract development and manufacturing organization (CDMO) specializing in aseptic and solid oral drug products, with a focus on complex formulations and end-to-end solutions for small to mid-sized biotechs.
Pii celebrates its 30th anniversary, congrats! In a few words, what distinguishes the company as a CDMO?
Pii’s uniqueness lies in its comprehensive approach to drug products. We specialize in both aseptic manufacturing and solid oral dosage (OSD), a combination typically found in larger companies. Being a medium-sized company, we provide agility and flexibility that larger organizations often struggle to match. While our business is dominated by aseptic manufacturing due to market demands, our OSD side remains integral.
What truly sets us apart is our focus on complex formulations. For instance, in aseptic manufacturing, we have expertise in handling high-viscosity, oil-based injectables and sustained-release drug products, which require unique sterile filtration techniques. Additionally, our ability to support projects from early-phase development through commercial launch is rare. Most companies specialize in either early or late-phase development, but we have honed our processes over 30 years to excel in both.
The pharmaceutical industry has evolved significantly since the company’s inception. How has Pii adapted to these changes?
The industry’s shift toward precision medicine and advanced treatments has necessitated adaptability, and Pii has risen to the challenge. Our facilities are designed for flexibility, allowing us to produce small to medium batch sizes efficiently. For example, we use robotic fillers in aseptic manufacturing, making us well-suited for precision medicine requirements.
We also excel in handling the complexities of modern pharmaceuticals. Many new drugs are potent or have solubility challenges, requiring specialized capabilities. On the OSD side, for instance, we use advanced processes like roller compaction to address solubility issues. By focusing on these evolving demands, Pii remains at the forefront of delivering innovative solutions for drug developers.
What is your typical client?
Our primary clients are virtual biotechs, which is our sweet spot. These companies rely on us because they lack the labs and manufacturing facilities but possess intellectual property. We act as an extension of their business, supporting them with our capabilities. While we do have large pharma clients, they are not typical for Pii. Our focus remains on small to mid-sized biotechs, with minimal interaction with big pharmaceutical companies.
These clients value our services because of our ability to partner closely and deliver tailored solutions. We provide the infrastructure and expertise they need to move their projects forward, creating strong collaborative relationships that drive their success and, by extension, ours.
What is Pii’s geographical presence?
Our operations are predominantly North American, with about 95% of our business based in the United States. We do supply some products to Canada and have one solid oral dosage product licensed for the European market, but our primary focus remains on serving the U.S. market.
This regional focus helps us maintain strong control over our operations and cater effectively to our clients' needs. While we have the capabilities to expand with a recently extended global footprint, our current strengths and resources are firmly centered on delivering value within North America.
How are recent developments, such as the Biosecure Act, impacting Pii’s business?
The Biosecure Act and reshoring trends are already impacting the industry. We are seeing shifts in supply chains and talent availability, especially with companies like WuXi Biologics closing plants. Additionally, capacity crunches are a significant challenge. For example, the acquisition of Catalent by Novo has reduced capacity in areas like cartridges and pre-filled syringes, creating pressure on manufacturers like us to fill these gaps.
Another major factor is the high demand for GLP-1 production, which is taking up substantial capacity in the market. As a result, some clients are being redirected to find new manufacturing partners. While the Biosecure Act plays a role, it is this combination of reshoring, capacity constraints, and talent availability that is reshaping the CDMO landscape, particularly in injectables.
What are your plans for Pii’s future growth and expansion?
Jabil, a global leader in engineering, supply chain, and manufacturing solutions, acquired Pii in February 2025, providing Pii with access to an expanded global infrastructure, cutting-edge automation, and enhanced supply chain efficiencies, enabling even greater responsiveness and innovation for their pharmaceutical partners. We will leverage Jabil’s extensive expertise to accelerate our mission of delivering best-in-class drug development and manufacturing solutions to our customers and ultimately the patients we serve.
Our business is currently 90% aseptic and 10% solid oral dosage (OSD), with 90% of our work being commercial and 10% in development. Looking ahead, we plan to grow our aseptic capabilities by investing in a third aseptic suite, while also building our early-phase development pipeline. To that end, we have launched the AccelevateTM platform, which aims to deliver from purchase order to clinic-ready product in just 100 days, leveraging streamlined processes and modeling software for rapid execution.
Additionally, we are exploring strategic partnerships, particularly in biologics, as the analytical and manufacturing needs of biologics align well with our expertise in sterile drug product finish. While we have seen exceptional growth in aseptic manufacturing, we are also aiming to reinvigorate our OSD business, which has significant untapped capacity. By balancing organic growth and partnerships, we plan to expand our capabilities and maintain our strong growth trajectory.
What strategic opportunities do you see in the future of the industry?
One significant opportunity lies in biologics, where partnerships with cell line developers could bridge the gap between API manufacturing and drug product finish. This area, where analytical complexity and sterile manufacturing meet, offers immense potential for innovation. Unlike the small-molecule side, biologics require a unique combination of expertise and infrastructure, making this a promising avenue for Pii.
While many companies claim to offer one-stop shopping, few deliver on that promise effectively. At Pii, we aim to focus on strategic collaborations that genuinely add value, particularly for biologics. Additionally, we are working to diversify our portfolio and reputation, expanding beyond our dominant aseptic operations to emphasize our capabilities in OSD. This multifaceted approach ensures that Pii remains competitive and poised for future success.
