As we proceed through 2023 and into the decade ahead, a diverse range of factors is expected to impact drug development and manufacturing. From the evolution of AI technologies to demand for new injectable dosage forms to an increased focus on sustainability, these trends will also affect packaging requirements.
While many of these changes will herald welcome improvements — new additions to the personalized medicine market, for example — they will also present challenges that pharma manufacturers must overcome.
Personalized treatments
Personalized medicines — treatments formulated with the specific needs, lifestyle and even genetics of an individual patient in mind — are expected to transform the pharma landscape over the next 10 years. With greater access to rich patient data than ever before, companies can create high-precision customized therapies that are more effective, with fewer side effects.
Due to their nature — tailored to individual patients — personalized medicines will pose manufacturing efficiency challenges that will need to be addressed. Production lines will need to adapt to smaller, more niche production runs.
Given the smaller batch sizes that personalized medicine will require, intelligent packaging processes will need to be developed, with multiple packaging formats, such as single-use vials or pre-filled syringes, that can accommodate smaller volumes of medication and a wider range of dosages and formulations. Additionally, because personalized medicines are likely to be more expensive than traditional, mass-produced drugs, considerations will need to be made around protecting and preserving the medication, such as tamper-evident packaging or specialized temperature-controlled packaging (e.g. RFID chips). The latter is particularly important since personalized medicine could result in products being delivered directly to the patient.
Similarly, personalized medicine will significantly impact labeling and patient education materials, which will need to be tailored with information about the specific patient, dosage and formulations. An aging population also means that we need to deliver complex information more accessibly. Alongside this is the need for multilingual information delivery, resulting in information needing to be delivered via a variety of media, for instance digitally generated hard copy booklets for the patient’s unique treatment regime or via smart barcode technology.
Proliferation of automation
Given the significant complexity brought upon by personalized medicine in filling and packaging processes, the related area of automation is poised as a potential solution to ensure process reliability and traceability.
Minimizing manual interaction with products and packaging helps avoid human error — which in turn reduces waste. As a bonus, increased automation brings an improvement to the level of sterile integrity found throughout the industry.
Automation is improving supply chain management for packaged drug products through better track and trace capabilities. Automated systems can track and monitor inventory during storage and in transit. This reduces waste, improves efficiency and helps tackle issues with counterfeit medicines.
However, companies must invest in new equipment and technology if they want to harness the benefits of automated systems. And some packaging processes, such as kitting for injectable drug products, may be harder to automate, particularly when manufacturing for multiple markets, each with its own labeling and packaging regulations.
Staff must be retrained so they have the necessary expertise to operate and maintain new equipment, and integration of these technologies into existing packaging lines can also be a challenge. Automation doesn’t negate the responsibility for visual inspection either — implementing adequate quality control still takes time.
Increased focus on traceability
Upcoming changes to the U.S. Drug Supply Chain Security Act (DSCSA) will have enormous implications for packaging and labeling logistics. The regulations will change labeling laws for pharma companies seeking to ship to the U.S. Companies and their contract packaging organization (CPO) partners are required to provide interoperable and electronic tracing for products at the package, case and pallet level from this year onwards.
Blockchain technology — a method of recording information that reduces the chance that a system is altered, hacked or manipulated — has the potential to make serialization more effective and efficient. Although not currently required by law, it can be harnessed to track products more thoroughly through production and storage to distribution.
Blockchain makes product tracking more secure, with fewer errors, and has the potential to fix global supply chain vulnerabilities, accelerate collaboration among companies, reduce fraud and assure product authenticity.
Specifically, a trusted blockchain and IoT-guided network could support a drug supply chain where controlled details such as temperature and location can be recorded in near real time using wireless sensors and GPS devices attached to the packages. Serial numbers and unique fingerprints of the manufacturer added to the label can then be scanned by the patient when purchasing the medicine to gain access to all relevant information. Under a blockchain supported system, the product manufacturer, pharmacy warehouse and pharmacy have access to complete, reliable and secure information about the origin (and quality, if blockchain can be extended to trace the origin of raw materials and medicinal products) of the drugs registered on the blockchain.
Currently, AI is used in drug development to analyze large amounts of data and identify potential drug targets, but it has the scope to transform both drug manufacturing and packaging. One area where we can expect to see enhancements thanks to AI is predictive maintenance to reduce downtime by implementing preventative measures before equipment begins to fail. Process optimization and inventory management are other areas where AI can more effectively identify potential improvements and ensure that necessary stock levels can be forecast.
In addition, detecting packaging defects — where a product defect causes the medication to leak and contaminate the packaging leading to waste and potentially putting patients at risk — can be significantly enhanced through AI. Packaging lines may make use of automated AI inspection systems to identify product or packaging defects early in the manufacturing processes, which can lead to increasing the overall efficiency of production. Deep learning AI models may offer a more robust inspection vs. traditional image processing techniques, as it can learn and adapt to changing environmental conditions, such as different lighting intensities. Ultimately, AI will enable an increase in speed through the packaging line, better quality control and more accurate product count.
As we progress through the decade, we can anticipate more sophisticated AI algorithms being developed to further enhance operations across drug development, manufacturing and packaging.
Focus on sustainability
Although sustainability is high on the pharma industry agenda, particularly within the packaging space, it’s still challenging to implement new packaging solutions that are both workable and biodegradable or recyclable. This is because all new packaging formats or materials must be tested for compatibility with drug products and approved by regulators.
Nevertheless, over the coming decade, pharma will have no choice but to revise its supply chain approach, moving to more responsible sources of raw materials for packaging, while also reducing its carbon footprint in transportation.
The concept of the circular economy, which emphasizes reusing and recycling materials, will also be applied to drug manufacturing. For example, drug packaging and containers could be designed for reuse or recycling, and waste from drug production could be repurposed.
Beyond simply enhancing recyclability in packaging, sustainability covers a broad remit. It’s about reducing the energy used in the manufacturing process, minimizing waste and changing our mindset as an industry.
Taking action for the future
In the wake of new industry trends, pharma’s challenges are not limited to packaging logistics and practices. It’s important that the industry, together with progressive-minded CPO partners, works to adapt to a shifting landscape and moving goalposts. The sector needs to remain proactive and dynamic while retaining the ability to react to sudden, unexpected changes.
Provided time and care are given to all the social, ethical and regulatory concerns presented, the industry has all the tools it needs to keep pace with whatever the future brings.
