PCI Pharma Services

When BioProcess International joined us for an Open Day at our Bedford, NH facility, they described it as an opportunity to “see a site purpose-built with the lessons of previous builds — designed for speed, scalability, and flexibility.” Built with both speed and scalability in mind, Bedford features a high-speed aseptic fill–finish line operating within a fully isolated containment system, capable of filling up to 400 vials per minute and handling batches of around 300,000 vials. With two 430 sq ft lyophilizers and expanded cleanroom space, the facility is purpose-designed to support complex, large-scale programs and ensure flexibility for future modalities. As Patricia Krainski, VP, Business Development, put it: “We grow to get different modalities and different types of projects and molecules that can support our clients.” That mindset shaped Bedford - built to help partners move complex therapies forward with confidence. Mark Shepanski, VP, Global Program Management, described Bedford as “the third in a series of builds… We’ve learned quite a bit along the way.” Those lessons show up in human-centered details - like glass-walled customer viewing so teams can observe without gowning, and smarter flows, airlocks, signage, and expanded clean storage to make work safer and smoother for everyone on site. Read the BioProcess International coverage of the open day and interviews here: https://lnkd.in/esP_774S

Winston Brown, Global Vice President of Digital Transformation and Operational Excellence, shares valuable industry insights on how he sees technology and analytics can be best utilized for optimized performance and agility in the CDMO space. With over 25 years of global experience in quality, technical operations, and regulatory compliance, I play a key role at PCI focused on continuous improvement. I implement digital transformation tools with a phased approach to foster a culture of quality. I assess operations and business processes to leverage technology and analytics for enhanced performance. My goal is to ensure product quality with a right-first-time mindset, eliminate waste, and maintain a reliable global supply chain. What we see in the CDMO space and the industry as a whole are primary trends driving the need for enterprise-wide digital transformation. Effective digital transformation can differentiate CDMOs and branded companies by leveraging big data and process analytics, leading to superior product quality, enhanced processes, and stronger control measures, providing a significant competitive edge. The demand for targeted therapies and customized manufacturing has grown significantly, leading to a need for smaller-volume, complex treatments. These therapies require unique manufacturing processes, highlighting the importance of efficiently processing and interpreting large volumes of detailed data to compete in this sector. Regulators are focusing on right-first-time quality by better understanding manufacturing processes using scientific, data-driven methods. Tools like continuous process verification, Quality by Design (QbD), and Process Analytical Technology (PAT) help monitor performance. Digital transformation provides a framework for manufacturers to meet these standards. Digital Transformation boosts manufacturers by automating processes, minimizing human intervention, and using analytics for condition-based monitoring, ultimately reducing downtime. Leveraging big data modeling helps maintain a validated state, positively impacting MCOGs and other operational and quality KPIs.. PCI Pharma Services is constantly evolving, having initiated an ambitious company-wide digital transformation strategy to ensure high product quality and maintain a consistently reliable global supply chain for our customers. In 2025, we implemented our Digital Quality Management System (QMS) across all locations and are now starting to deploy Electronic Batch Records (eBR) in collaboration with our strategic partner. We are also investing in modernizing our Quality Control Laboratories with Laboratory Information Management Systems (LIMS), a project initiated in 2024. Additional digital transformation initiatives are underway to improve operational performance, aiming to create a globally connected enterprise driven by big data and analytics. #CDMO #ExpertInsights #PowerOfExperience #LetsTalkFuture

This month marks five transformative years since PCI Pharma Services proudly launched pci | bridge™, our innovative digital supply chain platform, introduced in 2020. From day one, pci | bridge™ was developed in close collaboration with client input to redefine supply chain visibility, transparency, and operational efficiency. What began as part of our three‑year digital transformation strategy has evolved into a cornerstone of how we expidite access to life‑changing therapies. Over the past five years, pci | bridge™ has: - Transformed manual forecasting, reporting, inventory management, and document workflows into seamless, digitized processes.  - Delivered real‑time insights into inventory, production, and distribution.  - Supported over 5,000 clinical and commercial products, empowering more than 550 clients and 1,350 unique users per month with complete supply chain visibility.  - Received top industry recognition: Winner of the Supply Chain Excellence Award USA for Clinical Trial & Commercial Lifespan Management in October 2024. - Recognized as two-time winner of Top 100 Healthcare Technology Companies by the Healthcare Technology Report. Our journey continues with regular feature enhancements driven by user feedback and integrations. We are grateful to every client, partner, and member of the PCI team who has contributed to refining and evolving pci | bridge™ into its current form. We celebrate:  - Five years of accelerating insights and transparency  - Ongoing digital innovation guided by user collaboration  - A future filled with even faster, smarter, patient-focused solutions Thank you for being part of this journey. #LetsTalkFuture #CDMO #PowerOfExperience #pcibridge

We're delighted to reveal a brand-new feature that enhances transparency in clinical operations for everyone on pci | bridge™, our industry-leading real-time supply chain management platform. Introducing the Protocol Spend Widget, now available directly on your pci | bridge™ dashboard. Say goodbye to searching through emails, dealing with spreadsheet chaos, or performing manual calculations. Whether it involves packaging, labeling, shipping, distribution, or returns, every dollar spent is captured and updated in real-time. This revolutionary widget empowers our clients to: - Stay within budget with clear visibility into protocol-level spending. - Justify costs confidently and quickly. - Make smarter decisions faster across their portfolio. At PCI, we believe innovation is best driven by listening, and this enhancement is born from our clients' feedback and is one example of many ongoing improvements to pci | bridge™. This is the power of experience https://lnkd.in/eSWP5unE #LetsTalkFuture #CDMO #PowerOfExperience #pcibridge

The technology transfer of a monoclonal antibody (mAb) drug product for late-phase clinical and commercial launch is a complex and multifaceted process. It demands meticulous planning, robust risk management, and seamless collaboration across technical, regulatory, and operational teams. In this new article, Shawn Cain, SVP of Development & Manufacturing Steriles at PCI Pharma Services, shares insights on ensuring process scalability, analytical method robustness, regulatory compliance, and supply chain stability - each critical to a successful tech transfer and global commercialization. #CDMO #BiologicsDevelopment #TechTransfer #LetsTalkFuture

As the demand for patient-centric therapies rises, self-administered injectable advanced drug delivery and drug-device combination (DDC) products are becoming essential, not only at launch but from the very start of clinical development. Published in the latest edition of Manufacturing Chemist, William Welch, Executive Director of Market Development at PCI Pharma Services, shares his insights on why incorporating DDCs into clinical trials improves patient experience, strengthens data quality, and accelerates the path to commercialization. From prefilled syringes to autoinjectors, Bill explores the shifting paradigm and why forward-thinking sponsors are embedding these delivery systems into Phase 2 and Phase 3 studies. Full Article: https://lnkd.in/e7wqaZie #CDMO #DrugDeviceCombinationProducts #PatientCentricity #LetsTalkFuture

Missed our Navigating Global Trade Complexities in Pharma webinar? No problem, the on-demand version is now available, delivering insights on Tariffs, VAT, and Free Trade Zones. Hear from our industry experts,  Zachary Rupert and Gavin Morgan, as they demystify global trade in the pharmaceutical and biotech sectors while sharing invaluable insights on: - Practical tips for optimizing your global supply chain - Regulatory must-knows for importing/exporting APIs, clinical trial materials, and combination products. - How leveraging free trade zones and custom warehouses can deliver cost efficiencies - How tariffs and VAT affect pharma and biologics across major markets (US, EU, RoW). Plus a practical overview of tariffs, VAT, and free trade zones, as well as their impact on supply chain strategies. View Here: https://lnkd.in/ejastDzr #CDMO #ClinicalTrials #DrugDevelopment #LetsTalkFuture

Developing drug-device combination products presents a unique set of technical and regulatory challenges that can compromise quality, delay timelines, and increase risk. From integrating design controls and navigating human factors to ensuring regulatory readiness and commercial scalability, success requires a deeply coordinated, end-to-end approach. In this article, Bill Welch and Justin Schroeder from PCI Pharma Services examine the six key challenges involved in the development of combination products. They also discuss how PCI addresses these challenges through its integrated infrastructure, proven expertise, and commitment to expediting delivery to patients. #DrugDeviceCombinationProducts #PatientCentricity #CDMO #LetsTalkFuture

We are proud to announce that Ginger Jones, PCI's Senior Business Development Executive for Clinical Trial Services, will be giving the welcome remarks at Women In Bio's Life Sciences Night in La Jolla on August 20th! This event brings together trailblazers, innovators, and emerging leaders to celebrate and empower women in the life sciences, a mission that aligns perfectly with PCI's commitment to diversity, equity, and inclusion, a key aspect of our broader Environmental, Social, and Governance (ESG) strategy. As a champion for women in STEM, Ginger exemplifies the leadership, insight, and passion we value at PCI. Her participation in this event reinforces our belief that advancing science and promoting equity are inextricably linked. Event Information: https://lnkd.in/eqEHTjNi #ESG #WomenInScience #STEM #LetsTalkFuture

ExpertXchange Webinar - Last Chance to Register! Navigating Global Trade Complexities in Pharma: Tariffs, VAT, and Free Trade Zones Explained. Date: Wednesday 13th August 2025 Time: 8am PDT | 11am EDT | 4pm GMT | 5pm CEST Join our speakers, Zachary Rupert and Gavin Morgan, for an ExpertXchange webinar designed to demystify global trade in the pharmaceutical and biotech sectors. This session will provide a clear and practical overview of tariffs, VAT, and free trade zones (FTZs), as well as their impact on your supply chain strategy. Key takeaways include: - How tariffs and VAT affect pharma and biologics across major markets (US, EU, RoW) - How leveraging FTZs and custom warehouses can deliver cost efficiencies - Regulatory must-knows for importing/exporting APIs, clinical trial materials, and combination products - Practical tips for optimizing your global supply chain Whether you’re in supply chain, regulatory, finance, or manufacturing, this webinar will provide you with the tools to make informed, strategic decisions. Registration Link: https://lnkd.in/eTcgvrKv #CDMO #SupplyChain #RegulatoryCompliance #LetsTalkFuture