Whether it is potent oral solid dose, sterile injectable process development, scale up, technology transfer or custom packaging of specialist drug products, contract development and manufacturing organizations (CDMOs) like PCI Pharma Services are helping to meet demands of the marketplace.
PCI Pharma Services provides a comprehensive range of pharmaceutical services from the earliest stages of development through to commercial launch and ongoing supply. Tim Roberts, Chief Commercial Officer at PCI Pharma Services, discusses industry trends, including increased demand for specialty global manufacturing services, robotic technologies, the growing pipeline of biologics, supply chain risk mitigation, packaging capabilities, and investments in new facilities.
Contract Pharma: Please talk a little about PCI’s journey from its legacy roots as a provider of pharma packaging solutions to its evolution into a global, integrated CDMO solutions provider.
Tim Roberts: Established in 1971 and trading as Packaging Coordinators Inc. (PCI), we have been providing contract packaging solutions to the pharmaceutical industry for over fifty years. Over the last decade, PCI has made several strategic acquisitions and investments to both geographically strategic locations as well as adding state-of–the-art manufacturing capabilities. One such acquisition being Penn Pharmaceutical Services Ltd. in 2014, bringing with it an industry leading contained manufacturing facility for the safe processing of highly potent drug products, providing specialist capabilities and capacity for the ever-growing oncology market.
In 2015, the organization rebranded under the name PCI Pharma Services and has since continued to grow both organically and by way of further acquisitions, with Lyophilization Services of New England (LSNE) being the most recent acquisition. This strategic investment further expanded our global expertise in specialty manufacturing by adding sterile fill-finish and lyophilization capabilities, delivering on the vision to become a truly integrated, global, CDMO.
Today, PCI Pharma Services is a global CDMO operating 30 GMP facilities throughout North America, Canada, Europe, and the Asia Pacific region. We are proud to serve in excess of 1,700 customers with unparalleled expertise and experience in taking compounds from the earliest stages of development through to successful commercialization, delivering speed-to-market and commercial success for our clients and the patients we jointly serve.
Our continued growth enables us to support over 3,100 clinical trials, over 450 commercial molecules, and each year deliver over 90 commercial product launches. Our industry leading experience, operational flexibility, commitment to safety, supported by innovative technologies and our exemplary quality and regulatory record make us the partner of choice for biopharmaceutical companies around the world.
Contract Pharma: How is PCI committed to meeting client needs for integrated development and manufacturing solutions?
Tim Roberts: As part of the ongoing evolution of PCI and by listening to our clients, we launched speedsolutionsTM in November 2022. SpeedsolutionsTM combine core CDMO capabilities with additional value-added services and expertise, delivering an integrated approach to every client project, de-risking the supply chain by eliminating the need to transfer to alternative suppliers. Irrespective of where clients enter the PCI world, they will be supported with the option of an end-to-end solution both within specific phases of the product lifecycle and across their entire development to commercialization journey.
For example, a client entering the PCI world during Phase I can leverage our speedtostudy® solutions, offering services from the earliest stages of development including drug product manufacturing, primary and secondary packaging, storage, and distribution, supporting proof of concept and Phase I requirements with:
- Expert guidance understanding early phase safety and efficacy;
- Financial benefits accelerating Phase I timelines;
- Risk mitigation – managing strategy, inventory, and destruction;
- Faster First-In-Human – Xcelodose® microdosing and sterile robotic fill technologies; and Scalable manufacturing utilizing geometric scale-up for reproducibility.
With value-add solutions such as specialist in-house regulatory and analytical support, packaging development and design, artwork services, new product introduction and late-stage customization, we provide essential support services to our clients across the full drug product lifecycle from development through to commercialization helping to reduce complexity and expedite timelines to deliver life-changing therapies to patients.
Contract Pharma: What are the trends driving growth in highly potent oral solid dosages (OSDs)? What highly potent OSD processing capabilities does PCI offer, and how are you addressing the increased demand?
Tim Roberts: Latest insights from IQVIA1 position oncology as the fastest-growing sector of drug development representing 38% of the R&D pipeline. With advancements in science and technology, and a better understanding of the biology, immunology, and genetics of cancer, it has lead to the development and approval of powerful targeted therapies, capable of causing the complete durable elimination of tumors.
Precision oncology is transforming the way patients are treated. Many patient are receiving precision targeted immunotherapies that are tailored specifically to their disease. By their nature, targeted cancer therapies are more complex than conventional chemotherapies, making their formulation more challenging, they are often classified as being highly potent and as such, require specialized facilities, equipment, and contained processing technologies.
With over 35 years’ experience in the processing of highly potent drug products, we are experts and innovators in potent processing and delivering life-changing therapies to patients. With purpose-built facilities utilizing the very latest in containment technology, we offer fully integrated development, manufacturing and packaging solutions for oral solid drug products with an occupational exposure limit (OEL) as low as 0.01µg/m3.
Our fully integrated facilities with specialist contained engineering solutions allow us to provide safe, scalable, and flexible processes from early phase clinical supply through to commercialization. With common equipment trains from development to commercial scale, geometric scale-up delivers reproducibility and ultimately speed to market for our clients.
Meeting the increased industry demand for specialty global manufacturing services within the oncology arena we recently invested in two new contained facilities at our world-class UK site, dedicated to the manufacturing and packaging of solid oral-dose tablets and capsules. These new facilities double our large-scale processing capacity including dispensing and fluid bed granulation of high-potency solid-dose products at commercial scale. In addition, the new high-potency, multi-product packaging facility provides a fully integrated process, delivering end-to-end services for a global client base.
Contract Pharma: How is PCI responding to the growing demand for sterile fill-finish solutions?
Tim Roberts: Harnessing over 25 years in the sterile fill-finish and lyophilization manufacturing space, we provide integrated large and small molecule solutions for both clinical and commercial scale projects. Our global manufacturing capabilities in complex formulations and lyophilization covers a broad range of inject-ables including nanoparticles, mRNA, mABs, proteins, oligonucleotides, and other biologics across multiple delivery formats from vials and bottles to pre-filled syringes and autoinjectors.
As part of our global strategy to increase our sterile fill-finish capabilities and capacities, and to address the global capacity shortage, we continue to build on our current capabilities in biologic drug development and manufacturing.
With recent successful global regulatory authority inspections including the FDA, ANVISA and PDMA, and larger scale manufacturing investments, both our Madison, Wisconsin and Bedford, New Hampshire facilities provide flexible commercial-scale solutions for our clients. At the Madison site, we recently invested in additional large-scale lyophilization capabilities, doubling capacity. We are also expanding our presence at the Bedford site with a $100 million investment in a new commercial facility. This investment supports the construction of a 5,295 square meter facility expansion, enhancing capabilities and increasing capacity using state-of-the-art isolator technology including high speed, large volume sterile fill-finish lines with the capacity to fill 400 vials per minute and auto-loading twin 40 square meter lyophilizers.
We have also further invested in industry leading robotic technology to complement our existing global sterile fill-finish capabilities. This investment comprises two robotic Cytiva Microcell Vial Filler units supporting clinical scale manufacture, one located in San Diego, California and one in Melbourne, Australia. In addition, a larger-scale Cytiva SA25 Aseptic Filling Workstation, also located at our San Diego facility, allows us to deliver a seamless, end-to-end, sterile fill-finish solution across multiple dosage forms including vials, pre-filled syringes, and cartridges, with flexible small to large-scale production capabilities meeting the bespoke needs of our customers.
These robotic technologies provide advanced methodologies of improving efficiency, reducing cost, and increasing sterility assurance, and are gaining huge popularity for the primary filling of Ready to Use (RTU) containers such as vials, syringes, and cartridges.
Contract Pharma: Providing an end-to-end solution, are PCI’s packaging capabilities expanding and/or evolving?
Tim Roberts: With the pharmaceutical industry’s growing pipeline of biologics, the need for technically advanced manufacturing and specialized packaging support has grown considerably. Committed to being a market leader in the packaging of biologic products for our global clients, our goal is to support our customers in safely, and efficiently bringing their novel medications to patients.
Complementing our sterile manufacturing investments, we continue to expand our European and North American biotech Centers of Excellence for clinical and commercial packaging. These state-of-the-art facilities are equipped with advanced packaging technologies for the labeling and assembly of vials, cartridges, standard pre-filled syringes, advanced safety syringes, autoinjector and pen devices complete with integrated top-load Dividella cartoning and in-line serialization.
Most recently we announced an investment of $50 million in a new 200,000 square foot facility at our Rockford, IL, site to meet the growing biologic market need of specialized packaging for injectable drug delivery device combination products. With over 20 dedicated suites, the new facility will support the assembly and packaging of vials, pre-filled syringes, autoinjectors, and pen-cartridges such as those for glucagon-like peptide 1 agonists (GLP-1) for treatment of diabetes and obesity. The facility will be validated summer 2024 with capacity reservation available immediately.
Meeting the sensitive temperature requirements for these specialist drug products we are significantly increasing our global cold and frozen storage capacity and also bringing online the latest advancements in automated frozen packaging. This new technology will facilitate larger commercial-scale volumes, providing increased operational efficiencies, reducing quality and safety risks with accelerated speed to clinic during clinical development and thereafter, market commercialization.
Contract Pharma: How would you characterize the state of the pharma supply chain? Discuss PCI’s risk mitigation and dual sourcing strategies.
Tim Roberts: Recent events such as the pandemic, natural disasters, the war in Ukraine and disruption in labor through staff shortages have emphasized how vulnerable the industry’s supply chains truly are and underlined the crucial importance of robust risk mitigation strategies and the need for nimble and agile supply chains.
Although there is a broad movement towards the simplification of supply chains with biopharmaceutical companies looking towards single source supply partners, in truth, this needs to be balanced with the need to reduce risk when it comes to ensuring an uninterrupted supply of critical life-saving therapies.
Proactive supply chain analysis and scenario planning is needed and FDA draft guidelines ‘Risk Management Plans to Mitigate the Potential for Drug Shortages’ provides guidance to support drug manufacturers develop, implement, and maintain risk management plans. This new development is part of the FDA’s effort to address disruptions in manufacturing which cause drug shortages, specifically in the area where therapies are deemed as being critical to life.
A risk control measure noted in the FDA guidelines is the identification of alternative / back-up suppliers. Dual sourcing is a strategy biopharmaceutical companies are utilizing by appointing a second supplier to ensure continuity of supply for their life-saving drug products and to help mitigate risk should something untoward happen to their primary supply source. Dual sourcing can also be utilized to provide supply chain agility and flexibility to deliver any increase in demand, with a second source of supply manufacturing additional supplies outside of the original forecast.
At PCI, we recognize the importance of supply chain risk mitigation and work with several global clients on their dual supply strategy to ensure life-saving therapies reach patients when needed. With client needs varying from large pharmaceutical company internal policies insisting on a dual supply model for critical medicines in their portfolio, to smaller biotech companies who are considering selling an asset and needing to demonstrate supply chain assurance during the due diligence process, we offer flexible supply models to meet the needs of all our clients. From dual market supply, scale-up to address increase in demand, capacity reservation models to back-up supply when needed; we collaborate with our clients to help safeguard their supply chain.
Contract Pharma: What can we expect down the road from PCI as an integrated solutions provider—from development to commercialization across drug manufacturing and packaging?
Tim Roberts: Meeting the dynamic demands of the marketplace whether it be for potent oral solid dose, sterile injectable process development, scale up, technology transfer or bespoke packaging of specialist drug products, at PCI we will continue to provide a collaborative, creative, and tailored approach to deliver upon our mission of being the bridge between life-changing therapies and patients.
Regarded as a true pharmaceutical and biopharmaceutical supply chain solutions provider to our global customer base and by leveraging 50 years of experience, we have the experience to deliver a flexible approach and excellence in what we do. To continue being our customers’ bridge between life-changing therapies and patients, we will continue to invest in our digital transformation strategy to build even more collaboration and efficiency across our global organization and bring online the latest in advanced technologies to deliver new levels of customer experience.
Core to our values and beliefs is our global focus on environmental governance. Through our ESG strategy, we are committed to fostering environmentally sustainable performance, honoring a diverse and inclusive culture, and creating positive impact on our employees, supply partners, customers, patients, and the communities in which we live and work. We want to do what’s right for our employees, our customers, our communities, and the planet, while playing an important role in the supply chain for pharmaceutical products that improve and extend lives.
Demand for Sterile Fill-Finish, Precision Oncology Growing – Interview with Tim Roberts, Chief Commercial Officer, and Anthony Vecchione, Associate Editor, Contract Pharma | May 2023.