Pharmaceutical Manufacturing Matters Q&A with Jeff Clement

Contract development and manufacturing organizations (CDMOs) play a central role in the development and manufacture of today’s drug products.

In response to changing sponsor needs, CDMOs continue to invest in technology and capabilities to support pharma and biopharma companies across the drug development continuum from research and development to manufacturing and packaging.

The global pharmaceutical CDMO market size was estimated at $146 billion in 2023 and is projected to grow at a CAGR of 7.2% from 2024 to 2030, according to Grand View Research. This growth can be attributed to increasing investments by CDMOs to provide specialized services and capabilities to meet the demands for today’s advanced therapies. For example, the high demand for sterile injectables has led to the growth in outsourcing to CDMOs.

PCI’s Jeff Clement, Executive Director, Technical Sales – Development and Manufacturing, discusses key areas of investment, such as new manufacturing technologies to meet Annex 1 requirements, building out supply chains, and advanced drug delivery packaging, as well as insight into recent sterile fill-finish, lyophilization and injectable packaging expansions.

Can you provide an update on PCI’s announcement of an additional $100 million being invested into sterile fill-finish capabilities? 

Jeff Clement: As part of our global strategy to increase our sterile fill-finish capabilities and capacities, in 2022 PCI committed $100M to enhance our sterile fill-finish campus of excellence in Bedford, NH with a new 50,000 square foot multi-product facility. Over the past two years, we have meticulously planned, built-in aseptic processes by design, and methodically executed the expansion, allowing us to grow our breadth of services as a global CDMO providing best-in-class late-stage clinical and commercial scale, fully isolated vial filling and lyophilization solutions for new and existing clients. 

The built-for-purpose facility will provide increased capacity using Annex 1 compliant technology, including an aseptic fill-finish line within a fully isolated containment system, complete with twin lyophilizers (40 square meters / 430 square foot each) with automatic loading and unloading systems.  Processing batch sizes up to 300,000 vials at a rate of up to 400 vials per minute (vpm) provides much-needed large-scale capacity for the filling of life-changing small molecules and biologics, including high-value drug products such as mAbs, oligonucleotides, fusion proteins, and peptides.

With over 25 years of experience in lyophilization and sterile fill-finish manufacturing, PCI has developed industry leading technical expertise in the end-to-end processing of innovative and complex products. Truly supporting full product lifecycle management from formulation and lyophilization cycle development through clinical to commercial sterile manufacturing, this high-volume lyophilization and liquid filling facility provides our clinical-stage clients a seamless solution for scale-up as they prepare for commercialization.

What benefits does this new technology present to your clients?

Jeff: Our award-winning, large-scale vial filling and lyophilization line is one of the most versatile isolator lines in the industry having been systematically designed together by the manufacturers (groniger and SKAN) from the outset.

This innovative technology not only streamlines the filling process, but also ensures the highest level of sterility assurance for the final product. The enclosed system provides a vital line of defense against contamination, safeguarding the integrity of drug products and ensures the safety of both patients and operators.  The line employs the latest SKANFOG decontamination technology which has been proven to effectively eliminate any potential microorganisms. The SKANFOG system uses an advanced micro-nebulization process to optimize particle size of the VHP droplets, this technology uses 80% less VHP than traditional vaporization systems.

To meet the ever-growing product demand of some of the largest commercial requirements from our clients, this high-speed line can fill 400 vpm, fulfilling batch sizes up to 300,000 vials.  Designed to minimize product loss and utilizing smart fill technology including peristaltic pumps, defective vial identification prior to filling, re-stoppering, and under-fill correction ensures that there is no wastage of precious product. 

While minimizing any loss of API or Bulk Drug Substance, inline camera inspection systems check each vial for stopper placement and drug product. Our overarching philosophy at PCI, is to constantly strive for perfection, delivering a quality and sterility assured drug product to patients, while meeting regulatory standards including the recently revised Annex 1. 

When do you anticipate the site being operational?

Jeff: At the moment there is significant activity at the site with the lyophilization, filling and isolator equipment being installed which is always an exciting time in any expansion program.  Engineering and validation runs are scheduled to take place in the fall, with the site ready for GMP production in the first quarter of 2025.  We are inviting clients to visit the site from June of this year onwards, providing the opportunity to reserve capacity to secure their future sterile supply chains.

This site is the third large-scale high throughput isolator-based commercial sterile fill-finish facility that we have built across our global network in the last three years.  Our expert technical, engineering, and project management teams alongside our long-term contractor partners are experienced in delivering complex, time-sensitive capital projects and we have a high level of confidence in meeting the 2025 timeframe.

What efforts does PCI undertake to build robust supply chains and mitigate risk?

Jeff: Recent events have put a spotlight on the need for secure and nimble supply chains. Biopharmaceutical companies seek service providers that can provide robust integrated solutions to support their drug products throughout their development lifecycle from early phase development and clinical studies to commercialization, mitigating the need to transfer between suppliers therefore reducing supply chain complexity and risk. 

At PCI, ensuring the continuity of the supply of life-changing medicines is our highest priority.  As a truly integrated and world leading global CDMO, we are manufacturing, packaging, and supply chain experts, harnessing decades of experience and expertise to deliver seamless solutions with the ultimate aim of improving the lives of patients.

Providing scalable sterile drug product development, manufacturing, and lyophilization solutions from development to commercialization, together with integrated custom assembly and packaging solutions for injectables, allows for ultimate knowledge sharing and communication between teams to ensure the drug product packaging is optimized for the product, patient, and production.  This integrated approach across global manufacturing and packaging teams not only streamlines supply chains but also provides an accelerated delivery of life-changing therapies to patients.

A strategic aspect of our ongoing evolution and by listening to our clients, PCI provides speedsolutions™, delivering the ultimate in solution flexibility and complete customer-centricity.  Speed Solutions combines value-added services and expertise, bringing an integrated approach to every client project, de-risking their supply chain by eliminating the need to transfer services such as packaging design and artwork to alternative suppliers as well as providing expert regulatory and clinical support services. 

PCI continues to grow and as a world leading CDMO, we are truly spanning the drug product lifecycle, connecting development and commercialization, de-risking supply chains, and delivering true speed to market on behalf of our clients.  We are a strategic partner and an integral part of the supply chain in bringing life-changing therapies to patients. Our expertise combined with innovative technologies means we deliver more than just a service; we are a trusted partner sharing an industry-leading depth and breadth of knowledge.

What investments has PCI made in advanced drug delivery packaging supporting injectable dosage forms?

Jeff: Complementing the continued growth and investment across our sterile manufacturing network, we continue to expand our European, North American, and UK Centers of Excellence for the clinical and commercial packaging of patient-centric delivery systems.  These state-of-the-art facilities are equipped with advanced drug delivery packaging technologies for the assembly and labeling of vials, cartridges, standard prefilled syringes, advanced safety syringes, auto-injectors, and pen devices complete with integrated top-opening cartoning and in-line serialization. This combined with extensive global storage and distribution capabilities across a range of temperatures from controlled room temperature (15°C – 25°C), through 2-8°C, -20°C, -40°C, -80°C to -196°C, ensures a seamless solution.

Most recently we announced an investment of $150M in a new 310,000-square-foot final assembly and packaging Center of Excellence at our Rockford, IL, site to meet the growing market need of specialized assembly and packaging for injectable drug-device combination products.  With over 20 dedicated suites, the new facility will support the assembly and packaging of vials, prefilled syringes, auto-injectors, on-body injectors, and pen-cartridges such as those for the treatment of diabetes and obesity, as well as those needed for the ongoing growth in oncology and autoimmune disease treatments.  The investment at the Rockford campus will also bring online a 200,000-square-foot warehouse providing controlled room temperature, refrigerated, and frozen storage capacity.

What can we expect in the future from PCI as an integrated solutions provider?

Jeff: Addressing the dynamic needs of the market, whether it pertains to potent oral solid dose, sterile injectable process development, scale-up, technology transfer, or custom packaging of specialized drug products, PCI remains dedicated to fostering collaboration, creativity, and tailored solutions. Our purpose is that together, we bring life-changing therapies to patients.

With over 50 years of experience, PCI is a respected provider of biopharmaceutical supply chain solutions worldwide. Our expertise enables us to deliver flexibility and excellence in all that we do. To continue to bring life-changing therapies to patients, we will continue to invest in innovation, science, technology, and our digital transformation strategy, exemplify our commitment to simplifying processes, addressing the needs of our extensive client base, and ultimately expediting drug product delivery to patients.

Central to our values and beliefs is our global commitment to environmental governance. Through our ESG (Environmental, Social, and Governance) strategy, we pledge to uphold environmentally sustainable practices, foster diversity, and inclusivity, and positively impact our employees, partners, customers, patients, and communities in which we live and work. We recently published our inaugural Annual ESG Report, outlining our achievements and ongoing commitment to the targets set, aligning to the strategies of our customers as a trusted partner. We aim to act ethically, benefiting our employees, customers, communities, and the planet, while fulfilling a significant role in the pharmaceutical supply chain, and enriching and extending lives. 

Pharmaceutical Manufacturing Matters Q&A with Jeff Clement  | As seen in Contract Pharma | April 2024

Jeff Clement joined PCI Pharma Services in 2014. In his current role, Jeff provides technical drug product development and manufacturing support to PCI’s global business development teams. Jeff has over twenty-five years in the biotech and pharmaceutical industries and his career includes experience in the pharmaceutical discovery sciences, high throughput automation, clinical formulation development, and cGMP analytical and manufacturing contract services.

We are committed to supporting clients at every stage of the manufacturing cycle, delivering best-in-class services efficiently and effectively.

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