Advanced, Flexible Packaging Solutions to Meet Parenteral Product Demand

PCI Pharma Services has invested heavily in expanding capabilities to meet the growing need for parenteral packaging services to support a range of products from niche, personalized medicines to large-volume treatments.

Growing Market for Parenteral Packaging Services

The value of the global biopharmaceuticals market is predicted to expand at a CAGR of nearly 9% from $237 billion in 2018 to approximately $389 billion in 2024¹ with the bulk of biologic drugs being offered as parenteral formulations. Over the past several years, nearly 40% of new molecular entities approved by the U.S. Food and Drug Administration (FDA) have been injectable products.² Consequently, the value of the global market for parenteral drugs is also increasing at a CAGR of over 11% and will expand from $8.69 billion in 2017 to $18.2 billion by the end of 2024.³

The global parenteral packaging market, comprising prefilled syringes, cartridges, vials, bags, ampoules and other ready-to-use systems, is also expanding at a similar rate. Two different market research firms estimate that the market is expanding at a CAGR of slightly more than 11% and will reach values of $18.2 billion by the end of 2024⁴ and $19 billion by the end of 2026.⁵ The value of the global market for prefilled syringes accounted for more than 35% of the global parenteral packaging market value in 2018⁶ and is expected to expand from $4.9 billion in 2018 to more than $9.7 billion by 2025, at a CAGR of 10.7%.⁷

Secondary Packaging at PCI Pharma Services

PCI Pharma Services is committed to being a market leader in the secondary packaging of parenteral products. Our goal is to help our customers safely and rapidly bring their novel medications to patients. We have more than 50 years of experience in pharmaceutical packaging and support over 50 successful commercial product launches every year. Our global capabilities include packaging for large-scale projects requiring sophisticated integrated technologies and automation, as well as more targeted therapies for select patient populations.

Our insights and expertise enable us to provide packaging solutions that truly differentiate products. We deliver product to patients creatively and effectively, adapting to the unique requirements of each global market, including branded and generic pharmaceuticals and biotech medicines, over-the-counter drugs, consumer healthcare products, medical devices and specialty products. Our exemplary regulatory compliance record, combined with our expertise in international legislative requirements, ensures that we offer best-in-class service for every customer.

Our injectable delivery capabilities include ampoules, vials, cartridges and standard prefilled syringes, as well as advanced safety syringes, autoinjectors and pen devices, with services including both simple and complex kitting for clinical and commercial applications.

In handling biologic medicines, we maintain a comprehensive cold chain and ultra-cold chain portfolio with temperature ranges including refrigerated (2–8 °C), frozen (–20 °C, –40 °C, –80 °C) and cryogenic (–196 °C) for advanced medicinal therapeutic products (ATMPs), including cell and gene therapies. For parenteral drug products, our secondary packaging services include labeling, Tyvek blistering, device assembly for autoinjectors, cartoning, kitting, child-resistant and compliance-prompting packaging, overwrapping and more, all supported by serialization compliance.

Investing in a Center of Excellence for Injectables Packaging

PCI Pharma Services supports global commercial supply with ongoing investment in state-of-the-art facilities and advanced packaging technologies, along with a dedicated workforce focused on delivering a consistently reliable and outstanding performance.

One of our recent and noteworthy investments is a $20-million expansion of our biotech technologies, including advanced injectable delivery forms. Part of this investment includes expansion of biotech clinical and commercial packaging and release testing capabilities at our Biologics Center of Excellence in Philadelphia, as well as expanded cold-chain capacity at numerous global locations to further support our existing biotech infrastructure.

At our Philadelphia Center of Excellence, we are adding cutting-edge technologies for the labeling and assembly of state-of-the-art syringes, safety syringes, and autoinjector devices with integrated top-load cartoning and in-line serialization, as well as furthering our expansive onsite cold-chain storage.

This site specializes in smaller runs with frequent changeovers. The added technologies were selected in response to the needs of both existing and potential new customers. The expansion increases our syringe labeling and assembly capacity by approximately 50% and provides us with the ability to support multiple customers with autoinjector assembly and automated top-load cartoning. The new syringe labeling and assembly line includes multiple online cameras for real-time visual inspection throughout the entire process. PCI also has autoinjector testing capabilities for rapid offline destructive testing, including measured volume dispensed, needle protrusion and cap removal force that enable efficient product release.

Construction of the first new room was completed at the end of October 2019, with the top-load cartoning line fully installed by the end of November. A second room containing an automated, high-speed and flexible autoinjector assembly line will be completed in April 2020.

Focus on Flexibility

The new high-speed autoinjector assembly line was developed in close collaboration with the selected vendor to ensure maximum flexibility and automation. We were able to leverage our decades of packaging experience combined with a true understanding of the evolving market in the equipment design to deliver a truly differentiated customer offering.

Despite being a high-speed line, the new equipment is able to assemble three different types of devices on one machine with easy-to-change tooling completed in less than 30 minutes, even when changing formats and sizes. The cartoning line also includes multiple modules, two of which allow for manual operations if required. In addition, each of these modules can, at a future time, be replaced with other advanced capabilities as needed.

The new syringe line also affords precision labeling for products in which the label placement is critical. Furthermore, the line provides one inline process from insertion of the prefilled syringe through serialization and pack-out for shipment, as opposed to the more conventional lines where the entire process can take up to three steps. This streamlined process reduces the complexity of packaging operations and also ensures improved quality, particularly for cold-chain products.

Comprehensive Serialization Solutions

Providing patients with safe and effective medicines requires assurance that the pharmaceutical supply chain has robust security, maintaining the highest standards for safety and regulatory compliance with domestic and international regulations implemented to address the global integrity of the pharmaceutical supply chain. Through the use of integrated and multi-layered technologies, a systematic methodology has been undertaken to combat counterfeit drug products, thereby allowing for validation of the integrity of each drug package delivered to patients.

PCI is a global market leader in serialization. We have actively provided serialized commercial products for both domestic and global markets for many years, enabling a robust understanding of the detailed industry requirements. This industry expertise is further supported through our partnership with leading serialization technology provider Antares, the platform for our global serialization services.
We have implemented a sophisticated network of technologies to provide serialized drug product for our global clients. Partnering with clients as they develop and implement their global secure supply chain strategies, PCI’s dedicated team works to understand requirements providing flexible solutions based on the drug product, package configuration and ultimate market destination. This includes integrated serialization technologies for highly automated packaging and configurable off-line serialization technologies capable of providing serialization for almost any package format.

In addition, we support differing regulatory requirements in countries around the world, including in-line product aggregation, providing the confidence of structured parent/child relationships in the various levels of packaging integration, from primary, secondary and tertiary packaging to the pallet, captured in the completed batch. This aggregation solution allows clients to receive a secure and detailed account of their drug product, critical to a safe supply chain.

Data exchange for serialization is also flexible at PCI. Inbound and outbound secure data exchange in support of serialization allows clients to utilize and leverage existing EPCIS and ERP networks as part of their global strategy. PCI interfaces with client-preferred IT architecture, offering a seamless and secure networked data exchange for inbound codes, as well as completed and commissioned codes upon batch release. Furthermore, PCI’s experts engage with leading industry groups, such as GS1, to stay ahead of current and future complex serialization requirements as they continue to evolve for both developed and emerging markets.

True Partner in Managing Uncertainty

PCI’s experience in commercial product launch is unparalleled. We provide our customers with agility in a dynamic commercial market, giving the flexibility to adapt quickly to changing market demands and to capitalize on market opportunities.

For parenteral products, we support a diverse portfolio of conventional and specialty delivery forms, including transdermal patches, autoinjectors, pens and other injectables, plus eye care applications. Cold-chain products, controlled substances and highly potent products are also supported by PCI, along with packaging services for medical devices and combination products. In addition to providing packaging services, we support customers with innovative package development, from design to commercialization.

PCI is the preferred launch partner of many leading companies due to our heritage and experience in bringing new products to market. We leverage shared expertise to ensure that every detail of each product launch is accounted for. With a committed team of experienced professionals led by attentive and effective project management, we guide each product to a successful launch with dedicated customer service for the duration of the project life cycle. With best-in-class technologies, extensive capacity and substantial ongoing investment in our business, we provide value as a true partner in managing uncertainty.

References

1. Biopharmaceuticals Market - Growth, Trends, and Forecast (2019 - 2024). Rep. Mordor Intelligence. 2019. Web.

2. Van Arnum, Patricia. “Market View: Parenteral Drug.” DCAT Value Chain Insights. 23 Oct. 2019. Web.

3. Branch, Emilie. “Market on the Rise: Parenterals.” Contract Pharma. 13 Nov. 2018. Web. 

4. Global Parenteral Packaging Market Will Reach USD 18.20 Billion By 2024: Zion Market Research. Zion Market Research. 4 Sep. 2018. Web.

5. Parenteral Packaging Market by Product Type (Bags, Bottles, Ampoules, Vials, Prefilled syringes & cartridges), Material (Glass, Polymer, PVC, Polyolefin), by Region: Industry Analysis, Market Share, Revenue Opportunity, Competition and Forecast 2026. Rep. Futurewise Research. 2019. Web.

6. Parenteral Packaging Market Analysis: Prefilled Syringes and Bags Collectively Account for More Than 55% of the Overall Market Value During the Forecast Period: Global Industry Analysis (2013-2017) & Opportunity Assessment (2018-2028). Future Market Insights. 28 Aug. 2018. Web.

7. Prefilled Syringes Market Value to Hit $9.7 Billion by 2025. Global Market Insights. 29 Jul. 2019. Web.