James Bury, director technology at Tjoapack, examines the increasing need for innovative solutions in pharmaceutical packaging, emphasising novel approaches and emerging technologies that address changing packaging requirements.
Key Highlights:
- Packaging innovation is becoming more important due the increasing prevalence of sensitive biologics, counterfeit drugs, and changing regulations.
- Key trends driving the demand for innovation include the rise of biologics, the need to safeguard drugs from counterfeiting and tampering, and the necessity to comply with regulations like the DSCSA.
- Technologies like blockchain, AI, and automation provides the foundations for enhancing packaging efficiency, ensuring product safety and meeting sustainability objectives.
Tjoapack
Packaging is crucial in pharmaceuticals, protecting the integrity, safety, and efficacy of treatments throughout the supply chain and enabling product traceability. The pharmaceutical packaging market is projected to grow from $110.55 billion in 2024 to $176.94 billion by 2032, at a CAGR of 6.06%.
As the biopharmaceutical industry evolves with innovative products and changing regulations, packaging innovators must adapt to maintain compliance, meet product demands, and cater to patient needs.
Driving the demand for packaging innovation
Several trends drive the demand for innovation in drug packaging manufacturing, processes, and products:
Increasing prevalence of biologic drug products
Biologics are becoming more prevalent to address unmet medical needs, including chronic and rare diseases. In 2023, biologics accounted for 31% of the 55 new molecular entities approved by the FDA's Center for Drug Evaluation and Research.
Unlike traditional small-molecule drugs, biologics are highly sensitive, requiring strict and controlled environments throughout development, manufacturing, and supply. They depend on parenteral administration and must be manufactured in sterile conditions. Deviations from required conditions can shorten shelf life. Therefore, appropriate packaging solutions, effective monitoring, and cold-chain logistics are essential to ensure drug viability upon receipt by healthcare professionals or patients.
Safeguarding drug products throughout supply
Biopharmaceutical supply chains face risks like drug counterfeiting and tampering.
Drug counterfeiting: In 2023, the U.S. Drug Enforcement Administration confiscated 80 million counterfeit pills laced with fentanyl, significantly higher than in previous years. Counterfeit drugs pose severe threats to patient safety and compromise global supply chain integrity. Biopharmaceutical companies must implement robust solutions to combat counterfeit drugs.
Tampering: The World Health Organization estimates that around 10.5% of medicines worldwide are substandard or falsified. These can include repackaged products with inferior ingredients or altered labels to disguise their true origin. Patients consuming counterfeit therapies may not receive necessary treatment or could be exposed to harmful products, leading to serious health consequences. Pharmaceutical companies' reputations can also suffer if associated with ineffective or harmful counterfeit products.
Maintaining compliance with regulations
Regulations are continuously revised to ensure the highest safety standards. The Drug Supply Chain Security Act (DSCSA), enacted as Title II of the Drug Quality and Security Act in 2013, outlines steps for developing systems to achieve interoperable, end-to-end electronic traceability of drug products at the package level. Companies must comply with the DSCSA by November 27, 2024. Failure to comply could result in delays, impacting patient access to critical treatments.
Meeting sustainability objectives
Governments are implementing measures to address climate change, reduce carbon emissions, and minimise waste. The European Union proposes that all packaging must be recyclable, with plastic components comprising a minimum percentage of recycled material by January 1, 2030.
Introducing recyclable materials into pharmaceutical packaging is challenging due to considerations like drug compatibility, durability, and regulatory approval. Packaging in direct contact with medicinal products is exempt until January 1, 2035. Companies must find innovative and sustainable packaging solutions to meet these initiatives.
Enhancing biologic manufacturing and distribution with packaging innovation
Packaging solutions that consider patient and product needs are crucial for product viability and convenience. The industry is moving toward pre-filled syringes (PFS), which patients can self-administer, increasing usability, adherence, and convenience. With more treatments targeting rare and chronic diseases, there is a growing need for smaller-volume drug products. PFS handle smaller volumes and accommodate diverse dosage solutions.
Biologic products are sensitive and prone to aggregation and degradation, impacting safety and efficacy. They require controlled environments and cold chains throughout supply to remain stable and efficacious upon receipt by the patient.
Secondary packaging protects the primary packaging and drug product during delivery. When transporting temperature-sensitive products, smart packaging can monitor external temperatures throughout transit, reducing temperature excursions and notifying organizations if they occur. This ensures product stability throughout distribution and maximises shelf life.
The introduction of smart labels enables real-time monitoring. These labels contain processors like RFID chips or NFC technology that track and send data to receivers, feeding into a central database. Real-time tracking of temperature and environmental conditions ensures the integrity and safety of pharmaceuticals. Companies can use data from excursions to understand root causes and prevent recurrence.
Safeguarding drug products throughout the supply chain
Protecting drug products throughout the supply chain ensures they reach patients in the same condition they were shipped. Incorporating distinct identifiers on packaging via serialisation safeguards against counterfeit products. The DSCSA serialisation measures strengthen the FDA's ability to protect consumers from counterfeit, stolen, or contaminated drugs by enhancing detection and removal from the supply chain. The EU's Falsified Medicines Directive serves a similar role.
Smart labels enhance serialised tracking, carrying more data than traditional labels to meet serialisation regulations. Packaging innovators are also applying tamper-evident seals on outer packaging, such as blister packs, perforated caps, or foil stickers. As of February 9, 2019, the EU requires most prescription medicines and certain over-the-counter drugs to include anti-tampering devices on exterior packaging, making tampering evident.
Sustainable packaging in the biopharmaceutical industry
Sustainability in packaging is a significant concern due to environmental effects. Strategies to meet sustainability objectives include:
Eco-friendly materials: Using biodegradable plastics, recycled paper, and compostable materials reduces environmental burden.
Reduced packaging: Optimising designs minimises unnecessary components and drives cost savings.
Postponement packaging: Finalising products closer to the point of use reduces waste, inventory costs, and lost products.
Improved distribution efficiency: Optimising transportation routes and delivery schedules reduces environmental impact and improves delivery times.
By integrating these technologies, industry moves closer to a circular economy and contributes to global sustainability goals.
Continuous innovation with emerging technologies
To meet stringent regulations, sustainability goals, and drug product needs, packaging experts must continuously innovate and integrate advancing technologies to drive efficiency and ensure product safety and viability.
Blockchain-enhanced serialisation: Blockchain technologies enhance security by providing tamper-proof digital records of all transactions. This blockchain-guided supply chain enables real-time tracking of drug packs' temperature and location via wireless sensors and GPS devices, promoting data visibility and ensuring product quality.
Artificial intelligence (AI) drives efficiency: AI can enhance packaging workflows. Integrating AI into production lines enables predictive maintenance, minimising risks and delays. Deep-learning AI models provide robust inspection by adapting to changing environmental conditions, enhancing quality control, and optimising manufacturing processes.
Automation optimises packaging lines: Automated systems optimise supply chain management through enhanced track-and-trace. Monitoring inventory reduces waste, improves efficiency, and prevents counterfeit medicines. Automation minimises manual handling, reducing human error and waste, and helps ensure product sterility.
The future of packaging
Packaging plays a critical role in protecting drug integrity and efficacy from manufacturer to patient. Biopharmaceutical companies must prioritise packaging in supply chains to guarantee safety, compliance, and uninterrupted supply.
Partnering with specialised contract packaging organisations (CPOs) provides support to implement new packaging processes and strategies to meet changing regulatory requirements and evolving product needs while optimising packaging processes. With expertise and infrastructure for packaging innovation, CPOs can help harness emerging technologies to drive productivity and enhance serialisation.