Over recent years, PCI Pharma Services has made a focused and continued investment in growing its sterile fill-finish capabilities to support the growing demand for complex injectable therapies. This includes the addition of a new, large scale isolator fill-finish and lyophilization line at its Bedford, NH campus, alongside the strategic acquisition of Ajinomoto Althea in 2025, strengthening the company’s U.S. manufacturing imprint and technical expertise.

Further backed by significant investment from Bain Capital, Kohlberg, Mubadala and Partners Group, PCI is speeding up the expansion of its global sterile manufacturing network. In this Pharma Matters Q&A, Anshul Gupte, PhD, RAC Drugs, Vice President of Pharmaceutical Development at PCI Pharma Services, provides updates on the expansions in Bedford and León, Spain, and talks about the importance and advantages of being able to offer services across multiple modalities.

Contract Pharma: You are making investments at your sterile manufacturing sites in both the U.S. and Spain. What’s the importance of growing your footprints on both sides of the Atlantic, and what trends are driving that?

Anshul Gupte: PCI is growing its pharmaceutical development capabilities at its sterile manufacturing campuses in Bedford and León to include a dedicated Pharmaceutical Development Center of Excellence (CoE) at each location. The $11 million investment enhances our capabilities across various aspects of drug development. These range from first in human, early phase studies through to commercialization and beyond for formulation, process, and analytical support.

The global investments reflect PCI’s commitment to serving clients with integrated, end to end solutions for sterile injectable products. As demand grows for both innovative biologics and complex small molecules, pharmaceutical companies are increasingly seeking partners that can provide seamless development and manufacturing capabilities.

Strategic goals behind these investments are speeding up time to market, reducing technical risk, and making smoother scale-up possible from clinical to commercial manufacturing. By pairing our development and manufacturing capabilities, we provide clients with pathways that make sense. This pathway enhances efficiency, ensures regulatory compliance, and ultimately brings therapies to patients faster.

By growing our company on both sides of the Atlantic, we strengthen our ability to serve a global customer base with resilience, flexibility, and speed. This reinforces our commitment to operational excellence, global reach, and supply chain security. It also gives our partners the power to bring life changing therapies to patients worldwide with confidence.

CP: Being able to handle both small-molecule drugs and biologics opens up your flexibility. However, it also means having needed expertise on staff in both areas. What are the challenges to being equally adept in multiple modalities?

Gupte: Being equally adept in both small-molecule drugs and biologics offers significant flexibility. But it also presents distinct operational and scientific challenges. Each modality requires special expertise, infrastructure, and regulatory understanding. Small molecules typically involve known chemical synthesis and formulation pathways. By contrast, biologics demand advanced capabilities in formulation, analytical, processing, cold chain management, and the handling of highly sensitive large-molecule compounds. Maintaining top quality in both areas requires continuous investment in cutting edge technologies, robust quality systems, and highly skilled personnel.

One of the primary challenges faced can be talent acquisition and retention. Scientific experts in biologics, particularly in sterile formulation, analytical characterization, and process development, are in high demand worldwide. Ensuring teams remain skilled across multiple modalities also means ongoing training and cross functional collaboration. In parallel, facility design must keep flexibility in mind. Such elements as modular cleanrooms, adaptable equipment, and containment solutions help meet diverse product requirements while keeping strict regulatory compliance.

Other complexities lie in varied regulatory expectations, supply chains, and scalability considerations. Successfully handling all these needs requires strategic planning, integrated project management, and a culture of innovation. Investing in multi-disciplinary global expertise enables PCI to provide comprehensive, future ready solutions helping our clients in a diverse therapeutic landscape.

CP: Let’s get technical. Can you share details about added space or new equipment tied to the investments you are making at either site?

Gupte: Both Pharmaceutical Development CoEs should be in operation within the coming months. They can handle a full range of non-potent and highly potent small molecules and biologics in various drug product presentations. Examples include vials, prefilled syringes, cartridges, and ophthalmic bottles. Both CoEs, in addition to formulation, would be able to conduct integrated analytical development and stability.

Our scientific teams focus on helping pharmaceutical development across the product life cycle. Ways we do this include early stage developability assessments and Investigational New Drug-enabling studies. We also provide clinical services support to advance programs into the clinic. Additional capabilities include special lyophilization development for small molecules and biologics, including antibody–drug conjugates. Plus, we conduct studies designed to facilitate successful scale-up and market preparation.

Our dedicated teams further support the development of drug–device combinations, including transitions from vial presentations to device based formats. They also offer dedicated expertise in long acting injectables and ophthalmic product development, among other advanced formulation and delivery approaches.

Briefly, we have invested in a range of scalable pharmaceutical development equipment and instruments. Among these: ultrafiltration and diafiltration systems, freeze/thaw, photostability, high-throughput stability characterization, ball mill, microfluidics, semi-automated vial, cartridge, and syringe filling systems, lyophilizers, chromatography, dynamic light scattering, spectroscopy, and sub-visible particle instruments, and others.

CP: Do you find that more of your partners are looking for end to end services? How does that type of CDMO model encourage and develop trust?

Gupte: Yes, we are seeing a growing demand for end to end services for sterile injectables. Biopharma companies increasingly prefer integrated CDMO partners that can support the entire product life cycle. This means from development and clinical manufacturing through commercial fill-finish, drug-device assembly, testing, packaging, and distribution. Driving this trend primarily is the growing complexity of biologics and high value therapies. Other factors are, for example, faster time to market, managing costs, and reducing supply chain risk. Of course, this all takes place in an increasingly competitive environment.

PCI’s integrated CDMO model fosters trust by providing continuity, transparency, and accountability across every stage of development and manufacturing. With a single, experienced multi-disciplinary team carrying out the process, our clients benefit from streamlined technology transfer, reduced handoffs, and consistent quality standards. This integration minimizes the potential for delays, poor communication, and regulatory challenges, which ultimately improves reliability and speed to market.

Furthermore, from a developing point of view, pharmaceutical development is the foundation of an integrated sterile injectable approach. Our development CoEs don’t operate in isolation. They are part of a cross functional framework including analytical sciences, sterile operations, and device integration. This establishes the scientific and technical framework necessary to ensure successful scale-up, regulatory approval, and life cycle management.

At PCI, integrated sterile strategies begin with complete understanding of the molecule and extend through formulation optimization, process development, analytical characterization, and packaging selection. Early collaboration enables us to apply deep technical expertise and quality-by-design principles. This optimizes processes and ensures scalability from clinical trials to commercial production. Our unified project management structure and robust quality system further reinforce confidence.

By keeping close to clients’ strategic goals and acting as an extension of their teams, PCI’s end to end solutions foster long-term partnerships built on performance, transparency, and shared success.

CP: What does the future hold? Will you be making any other investments soon?

Gupte: The future of PCI is defined by continued strategic investment to meet the changing needs of our pharmaceutical and biotech partners. As demand for complex and sterile therapies grows, we are focused on building out capabilities that enhance flexibility, scalability, and supply chain resilience to deliver truly end to end services for life changing therapies. Future investments of over $1 billion, announced recently, will notably deepen our sterile fill-finish and advanced drug delivery capabilities. At the core of this investment plan is growing our U.S. and EU syringe and cartridge filling capabilities and capacities, building upon our drug-device assembly infrastructure and cold chain capacities, together with investment in advanced automated visual inspection systems and digital technologies to support next-generation drug products such as biologics, mRNA-based therapies, and highly potent compounds.

Our investment strategy is guided by customer demand, scientific innovation, and long-term industry trends. Ultimately, the goal is to ensure we remain a trusted, forward looking partner that can support the development and commercial status of life changing therapies for patients worldwide.

CP: What are the primary scientific and technical challenges associated with developing sterile liquid formulations for small molecules versus biologics?

Gupte: While both categories require strict controls, their development challenges differ significantly.

For small molecules, key considerations include:

• enhancing solubility and bioavailability
• keeping chemical stability, with degradation at a minimum
• optimizing pH, buffering systems, and excipient compatibility
• ensuring compatibility with elastomers and container closure systems.

Biologics, such as monoclonal antibodies, peptides, and recombinant proteins, demand a more nuanced approach. These molecules are sensitive by nature, and can fall victim to aggregation, denaturation, and oxidation. Development strategies must address:

• stability and aggregation control 
• keeping subvisible and visible particulates at a minimum
• protection against shear stress and interfacial instability 
• control of extractables and leachables
• maintenance of potency and structural integrity throughout the product life cycle.

Analytical characterization plays a pivotal role in biologics development, using advanced techniques such as size-exclusion chromatography, dynamic light scattering, mass spectrometry, and spectroscopy. Ultimately, a deep understanding of molecular behavior is essential to ensure product quality, safety, and effectiveness.

CP: What are the advantages of having pharmaceutical development laboratories at sterile fill-finish manufacturing sites?

Gupte: Co-locating our pharmaceutical development CoEs within our good manufacturing practice (GMP) sterile manufacturing and lyophilization facilities is a key differentiator and offers significant scientific, operational, and regulatory benefits. From a technical point of view, the close proximity enables seamless technology transfer and facilitates real-time collaboration between formulation scientists, analytical experts, and manufacturing teams. This integration ensures that processes are designed with scalability and manufacturability in mind from the outset.

Key advantages include:

• Accelerated development timelines: Rapid iteration and troubleshooting minimize delays. 
• Enhanced process understanding: Direct access to manufacturing environments supports robust process development. 
• Reduced technology transfer risk: Eliminating site-to-site transfers minimizes variability and misalignment. 
• Improved container closure integration: Early compatibility studies with vials, syringes, and cartridges. 
• Regulatory readiness: Alignment with GMP requirements and regulatory expectations from early stage development. 
• Operational efficiency: Streamlined communication and project management.

Ultimately, this model strengthens the connection between formulation design and commercial manufacturing. It improves product quality and speed to market for our clients and their patients.

CP: How do these CoEs enhance the overall tech transfer process and reduce development timelines?

Gupte: Having both functions co-located allows for iterative learning. If we observe, say, viscosity related filling challenges during small scale trials, we can adjust formulation rheology or container closure design within days rather than weeks. Analytical support is on-site too, so stability or particulate assessments can be fed directly into engineering runs. That integration translates into shorter development cycles, fewer elements of surprise at scale-up, and ultimately faster time to clinic or market for our partners.

CP: Looking ahead, how do you see pharmaceutical development of sterile liquids changing, and how will PCI support future industry needs?

Gupte: The future of sterile injectable development will be shaped by innovation, complexity, and patient-centricity. We anticipate continued growth in targeted therapies, particularly in biologics but also small molecules, as well as increasing demand for ready to use, ready to administer formats.

For PCI, the future is about deeper scientific integration and smarter development decisions that speed up innovation while keeping the highest quality standards. I expect to see greater use of automation, robotics, and data driven formulation design, using predictive modeling to anticipate formulation or process risks before material is ever made. There will also be increased focus on sustainability and manufacturing efficiency, particularly in keeping product loss to a minimum during aseptic filling.

PCI is well positioned to support these changing needs through ongoing investments in scientific expertise, advanced technologies, and integrated sterile injectable capabilities. Our focus remains on high quality, flexible, and scalable solutions that enable our clients to bring life changing therapies to patients around the world.