Global Integrated CDMO: Brad Payne Talks with PharmaTech Outlook

From the race to develop COVID-19 vaccines to advancements in novel treatments, the pharmaceutical space is witnessing an unprecedented scale of innovation. Agile and flexible operations to rapidly bring life-changing therapies to patients are at the core of every pharmaceutical company’s mission.

PCI Pharma Services has earned a solid reputation as a strategic, full-service CDMO partner, offering clinical and commercial drug product manufacturing, packaging and supply chain solutions that enable pharmaceutical companies to bridge the gap between life-saving drugs and patients faster. It assists global biopharmaceutical companies from the early stages of the drug development lifecycle to commercial launch and beyond. 

As a global integrated CDMO, PCI offers a comprehensive range of services, from drug product development and manufacturing to commercial packaging and global launch. The company’s specialist contained manufacturing and packaging facilities dedicated to processing highly potent drug products, combined with its renowned lyophilization and sterile manufacturing capabilities are complemented by a global network of packaging facilities to deliver a true end-to-end service for their client partners.

Our journey of nearly half a century, from being a commercial drug packaging company to becoming a strategic partner to pharmaceutical companies, has been inspiring,” says Brad Payne, COO at PCI Pharma Services. “The vast expertise we have accumulated over this period is instrumental in addressing the pain points in the industry, which currently has tens of thousands of assets under development. Internal capacities of many pharma companies are spread thin, and outsourcing this responsibility to a trusted CDMO like PCI is key to meeting the surging demand.”

Integrated Solutions to Simplify the Supply Chain

PCI’s speedsolutions™, a robust consultative service, is purpose-built to offer the speed and flexibility demanded by today’s clients. It comprises speed-to-study, speed-to-patient, speed-to-approval, and speed-to-launch, aligned to the phases of the product lifecycle to supercharge drug development and supply. Through these services, PCI is able to provide seamless and expedited solutions at critical moments in a program lifecycle. The speedsolutions™ offering combines both core services expected of a CDMO with additional value-added services for which clients may historically have utilized additional third party vendors. Such services include package design & development, artwork services, clinical supply management, regulatory support and late stage customization to name but a few. By offering these additional services, PCI is able to assist in reducing the overall complexity of vendor management for clients.

For example, PCI’s highly skilled packaging design and development experts maximize agility and efficiency in operations. They support design conceptualization at the early stages, facilitating informed decisions about material selection and driving patient-centric design and user interaction for ease of manufacturing. Expertise in environmental-friendly packaging is also a value add. Rapid prototyping and late-stage customization capabilities through cutting-edge technology provide the utmost flexibility to clients.

Another competitive differentiator for PCI is its clinical Supply Management and Readiness Team (SMART) service, designed to manage the clinical drug supply of small and midsize clients that lack the resources to tackle the complexities of Phase I, II, and III clinical trials internally. SMART members embed themselves into customers’ operations and manage the entire supply chain for them, ordering required items, coordinating schedules of bills, shipping products to depots around the world, and getting the product to clinical trial sites on schedule. 

We came across the challenges associated with managing clinical supply chains on multiple occasions and decided to fulfil this unmet need within the market. SMART is one of our largest value-added Speed Solutions to date,” says Payne. 

Clients often encounter challenges during the final stages of production in new product launches. Recently, one client working on a blockbuster drug administered through an advanced drug delivery autoinjector ran out of internal capacity. Within nine weeks, we were able to assist in getting them back up-to-speed on serializing, packaging, and assembling the autoinjectors to manage demand. 

Regulatory services are also a part of the integrated solution we offer, helping clients with regulatory support throughout the product lifecycle including global regulatory filings with authorities such as the US FDA, MHRA, EMA, PDMA, ANVISA etc. As part of this solution, Qualified Persons (QPs) are also able to audit a client’s drug development supply chain to ensure compliance with regulatory standards. 

The real value proposition of our Speed Solutions offering is being a single source for all aspects of a project, eliminating the complexities of working with multiple vendors to bring a product to market.

Driving Innovation through Strategic Investments 

To bolster its services, PCI continues to invest and increase its capabilities and capacity in high-growth development areas such as sterile drug product development & manufacturing, combined with the use of more patient-centric advanced drug delivery formats including prefilled syringes and autoinjectors. PCI has invested significantly in both manufacturing and packaging facilities to support clients in their growth journey. Investments in state-of-the-art manufacturing capabilities combined with biotech centers of excellence for advanced drug delivery packaging delivers a seamless solution for clients at every stage. As part of PCI’s philosophy of always being one-step ahead, we identify key growth areas by leveraging our partnership with Trinity Life Sciences, a consultancy firm providing evidence-based solutions for the life sciences market. 

These strategic investments have proved highly beneficial for our client partners.  For example, one client developing a drug for macular degeneration, identified that patients were more prone to eye infections when the drug was drawn manually from a vial to a syringe. To overcome this challenge, they decided to change drug delivery format to prefilled syringes. Utilizing PCI’s sterile development and manufacturing expertise, the transition from vial to prefilled syringe was successfully made helping to significantly reduce infection rates and create a safer treatment pathway. 

Significant investments have also been made in automated vial-filling lines. Currently, PCI has allocated a $100 million budget for a high-speed multi product sterile vial filling line with integrated twin lyophilizers in Bedford, New Hampshire, for batch sizes up to 200,000 vials processing up to 400vpm utilizing full isolator technology. This is complemented by strategic investments in adding gloveless, fully automated, robotic sterile-fill-finish capabilities at its San Diego, California, and Melbourne, Australia facilities supporting the aseptic filling of RTU components such as vials, syringes and cartridges for autoinjectors.

On the packaging side, the company has invested over $100 million in its Philadelphia, Pennsylvania commercial packaging facility to increase capabilities and capacity for the biotech market with advanced drug delivery packaging of prefilled syringe assembly, autoinjector and drug-device combination products. It is also building a second facility in Rockford, Illinois, at a cost of $150 million to expand its biologic packaging capabilities with additional vial, prefilled syringe and autoinjector assembly and packaging technologies.  This additional facility will be operational in summer 2024, with capacity reservation available to clients immediately. 

These strategic investments across both manufacturing and packaging, allow PCI to provide integrated end-to-end solutions, helping to reduce supply chain complexity and risk for their clients Combining expertise in sterile fill-finish manufacturing with specialist advanced drug delivery biologic packaging, labeling and cold chain distribution provides a valuable end-to-end solution, simplifying supply chains while delivering time and cost efficiencies.

A True Global Proposition

Maximizing its reach to serve global clients has always been top-of-mind for PCI, which now operates 30 facilities across North America, Europe, and Asia Pacific. PCI assigns key account managers to avoid bottlenecks within operations across its global network of facilities. 

The account manager works with multi-disciplinary teams from the various sites and coordinates the process at each step to ensure key milestones are met and life-changing therapies are delivered to the patient. For instance, if a potent, oral, solid dose product for a global client is manufactured in Tredegar, Wales, and has to be transported to Rockford, Illinois, for packaging, the key account manager will manage the transition between sites, technologies, and segments providing streamlined project management support for its client.   

Multimodal supply chains that span many countries and continents are accompanied by inherent challenges such as logistical interruptions and quality and regulatory bottlenecks,” says Justin Schroeder, global vice president of technical sales at PCI Pharma Services. “The most effective mitigation strategy is to work closely with vendor partners in developing preventative measures and being as communicative as possible to work hand-in-hand.” 

Here, its digital supply chain management platform, pci|bridge™, plays a key role. It is designed to provide clients with real-time insights into their portfolio of work at different PCI sites. pci|bridge™ updates customers on their supply chain status and inventory levels, enabling them to place orders beforehand to avoid shortages. Clients can also identify potential risks and the best-suited plan of action to mitigate them. 

Taking its superior customer service a notch higher and building upon its extensive experience, PCI recently established a Global Program Management function dedicated to building facilities for clients and / or bespoke processing suites within existing multi product facilities.  This function comprises a dedicated team of program managers, quality engineers, and supply chain managers who work with clients to build such facilities and suites bespoke to their product needs.  This is a key area of partnership for PCI’s clients as they look to mitigate risk in their supply chain and develop more strategic relationships with their CDMO. Dedicated to providing exceptional services to its global client base, PCI is committed to expanding its footprint and capabilities in key geographical locations including Asia Pacific. With a global reach and local focus, PCI is driving innovation across the drug development lifecycle, upholding its reputation as a leader in the CDMO space and delivering life-changing therapies to patients.

PCI Pharma Services – A Leading Global Integrated CDMO – With Brad Payne, Chief Operating OfficerPCI Pharma Services. | As seen in PharmaTech Outlook | September 2023.

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