PCI Pharma Services

As the demand for refrigerated biologics continues to rise, maintaining precise temperature control and ensuring end-to-end traceability has never been more critical. In the latest issue of Healthcare Packaging, Justin Schroeder, Global Vice President of Technical Sales, discusses how PCI Pharma Services is using digital innovation to enhance serialization, cold chain management, and product integrity across its global operations. With biologics now accounting for over 40% of drugs in development, our ongoing investments in digital systems, cold chain infrastructure, and new global facilities enable clients to bring their injectable and drug-device combination products to market with precision, compliance, and confidence. From implementing the Time Out of Refrigeration (TOR) system to monitor the duration that biologics spend outside of cold storage, to adopting advanced serialization and aggregation technologies, we are transforming how CDMOs can protect high-value, temperature-sensitive therapies. Read the full article here: https://lnkd.in/ePCiUuku #ColdChainPackaging #AdvancedDrugDelivery #PharmaManufacturing #LetsTalkFuture

The success of groundbreaking therapies depends on the precision, foresight, and agility of the clinical supply chain. Our latest article in the Journal of Clinical Studies explores how PCI Pharma Services' Supply Management and Readiness Team (SMART) transforms clinical supply management from a logistical challenge into a strategic enabler of trial success. Brian Keesee, President, Clinical Trial Services, and Ed Groleau, Senior Director, Clinical Supply Chain, discuss how operational excellence contributes to patient safety, ensures regulatory compliance, and promotes continuity in clinical trials. Covering everything from early engagement and innovative packaging design to global logistics planning and preparing for risks across all phases of the process. Read the full article: https://lnkd.in/erUXvJSU #ClinicalTrials #PharmaSupplyChain #CDMO #LetsTalkFuture

Tariffs are significantly reshaping the global pharmaceutical supply chain, leading to increased cost pressure and operational uncertainty for manufacturers. In a recent article for Pharmaceutical Outsourcing, Zach Rupert of PCI Pharma Services provides a clear and practical framework for understanding where tariff exposure occurs and how organizations can begin to mitigate it. “The Tariff Mitigation Toolkit” explains how changes in U.S. trade policies, duty classifications, country-of-origin rules, and global sourcing models can impact everything from component procurement to final product distribution. It also outlines proven mitigation pathways, such as Foreign-Trade Zones, prototype provisions, and strategic supply chain redesign. As companies reassess their global operations, this perspective offers valuable guidance for future planning. Read the full article: https://lnkd.in/eDAUksuG #PharmaceuticalManufacturing #SupplyChainStrategy #TradeCompliance #LetsTalkFuture

Upcoming Webinar – Save Your Spot! From Clinical to Commercial: Introducing Devices Earlier to Streamline the Drug-Device Combination Journey December 4, 2025 | 8am PST | 11am EST | 4pm GMT | 5pm CET As parenteral therapies become increasingly patient-centric, drug developers are recognizing the importance of introducing delivery devices such as prefilled syringes, cartridges, autoinjectors, and pens earlier in clinical development. Join Bill Welch & Justin Schroeder for an in-depth webinar exploring how making informed device choices in the early phases of clinical development can have a profound impact on scalability, manufacturability, and speed to market later on. Learning Objectives By the end of this session, you will: - Understand the benefits of introducing device strategy and selection earlier in clinical development. - Learn how early alignment between clinical and commercial manufacturing can reduce cost, risk, and time to market. - Explore how integrated solutions can support seamless scale-up from pilot to full-scale production. - Identify key considerations for device assembly, packaging, and testing that enable regulatory and commercial readiness. - Review emerging trends in early device adoption and combination product development. Whether adapting a platform device or developing a custom solution, attendees will gain a practical understanding of how to align early-phase clinical planning with long-term commercial objectives, creating a flexible, efficient pathway from first-in-human studies to global launch. Don't miss this opportunity: https://lnkd.in/eR9E2QCa #AdvancedDrugDelivery #PatientCentricity #ClinicalDevelopment #LetsTalkFuture

Targeted Protein Degraders (TPDs) are rapidly emerging as a key area in oral therapeutics; however, effective delivery continues to pose scientific and strategic challenges. In this expert-led article, Dr. Rebecca Coutts, Senior Director of Pharmaceutical Development, explores how strategic partnerships and enabling technologies such as spray drying, hot melt extrusion, and nanomilling are helping overcome the 'brick dust' challenge of TPD bioavailability. Discover how PCI Pharma Services' science-led, platform-agnostic approach is helping transform TPDs from promising discoveries into viable, patient-ready therapies: https://lnkd.in/etFMhE4B #TargetedProteinDegraders #OralTherapeutics #DrugDevelopment #LetsTalkFuture

Today, PCI Pharma Services joins the global community in recognizing World Diabetes Day and raising awareness of a condition that affects more than 500 million adults worldwide. For many individuals living with diabetes, injectable therapies such as insulin and GLP-1 receptor agonists are essential to maintaining health and quality of life. At PCI Pharma Services, we’re proud to play a vital role in this healthcare journey, supporting our partners from clinical development through to commercial supply. Our expertise in aseptic fill-finish, device assembly, testing, packaging, and global distribution ensures that critical injectable therapies reach patients safely, efficiently, and with the highest quality standards. Through our commitment to excellence, innovation, and patient centricity, we support our partners to deliver therapies that empower patients and improve outcomes worldwide. #DiabetesAwareness #WorldDiabetesDay #AdvancedDrugDelivery #LetsTalkFuture

At PCI Pharma Services, innovation is about more than efficiency. It’s about responsibility. In our latest feature in ONdrugDelivery Magazine, Lori Jackson, Senior Director, Global Digital Quality & Program Management, and Tim Hansen, Global Director, Sustainability, highlight how Electronic Batch Records (EBRs) are reshaping pharmaceutical manufacturing to be smarter, leaner, and more sustainable. By replacing paper-intensive processes with digital systems, we are reducing waste, cutting carbon emissions, and creating a foundation for continuous improvement across our global network. This digital transformation not only supports regulatory compliance and operational efficiency but also delivers measurable environmental benefits that contribute to long-term sustainability. Read the full article in OnDrug Delivery to see how PCI is leading the way toward a greener pharma industry. https://lnkd.in/e23g3mTW #LetsTalkFuture #CDMO #PowerOfExperience #pcibridge

Earlier this year, the UK officially signed into law a major overhaul of its clinical trial regulations, the most significant update in more than two decades. Full implementation is set for April 28, 2026, marking a pivotal moment for the country’s clinical research landscape. As Shawn Murtough, Director of Quality and Regulatory Services at PCI Pharma Services, explains: “These reforms align closely with many of the features introduced under the EU Clinical Trial Regulation, signalling a strong commitment to efficiency, transparency, and innovation. The UK is clearly seeking to position itself at the forefront of clinical research, offering Sponsors a faster route to trial approval and start-up.” For full insight into the changes strengthening the UK’s position as a global hub for clinical development click here: https://lnkd.in/esAmDTxs #ClinicalTrials #ClinicalDevelopment #CDMO #LetsTalkFuture

Driven by chronic disease prevalence, wider biologic and biosimilar therapy adoption, and the shift to user-friendly combination products, market analysts estimate double-digit growth for PFS through 2030. Combining integrated sterile fill-finish, device assembly, testing, and global packaging, PCI Pharma Services delivers flexible, scalable, and integrated solutions to meet the growing demand for ready-to-use injectable formats. From supporting the most significant global patient populations to the rarest of disease programmes, our investments in US and European facilities, technologies and new capacities enable clients to accelerate speed to market while maintaining the highest standards of quality and safety. The latest issue of Pharmaceutical Manufacturing and Packing Sourcer (PMPS) highlights how we combine our expertise, infrastructure, and scalability to support the evolution of prefilled syringes and drug device combination products. Read the full spotlight to explore how PCI Pharma Services is powering the next generation of patient-centric drug delivery systems and ensuring reliable supply from clinical through commercialization. https://lnkd.in/eUJyFZh3 #PatientCentricity #DrugDevelopment #AdvancedDrugDelivery #LetsTalkFuture

Oral liquid dosage forms are rapidly evolving, and the implications for drug development are significant. In this insightful article, Louise Carpenter and Catherine Lloyd from PCI Pharma Services examine the emerging trends and key challenges that are shaping the future of oral liquid formulations. They discuss important topics such as enhancing solubility and stability, as well as optimizing patient-centric formulations for diverse populations. Learn how a science-driven, phase-appropriate approach can address formulation complexities, streamline the scale-up process, and accelerate the delivery of innovative therapies to patients. Read now to discover how PCI is advancing the next generation of oral liquid therapeutics. https://lnkd.in/e3NkDRSb #CDMO #OralLiquidFormulations #PatientCentricity #LetsTalkFuture