Amid the evolution of the pharmaceutical industry, and more recently catalyzed by the coronavirus (COVID-19) and its implications on drug demand, delivery and the supply chain, parenteral drugs are experiencing increased demand. Whether administered intravenously, intramuscularly, or subcutaneously, the format creates new and critical avenues for drug delivery thanks to some favorable attributes around safety and efficacy. For one, parenterals allow for a controlled release—either gradual or instantaneous—that an oral medication cannot always provide. This format is critical to providing immediate pain relief, such as with epidurals during childbirth, or for continuously managing fluid levels, such as with saline solutions delivered via IV. Parenterals also encourage patient adherence—often by requiring a clinician for administration—minimizing the opportunity for error and the subsequent costly, dangerous consequences.
Still, parenterals cannot perform correctly if the formulas are compromised while in production or en route to patients. Each medication must be safeguarded from the initial phase of manufacturing all the way to the point of use. This makes packaging a critical piece of the puzzle in sealing off the drug formula from any outside elements—and ensuring that no leachables from the packaging itself could compromise the integrity of the formulation.
In addition, the market will continue to evolve and bring new drugs into the equation to meet patient needs. Emerging formulas will come with their own sensitivities and requirements for remaining sterile and effective, making that journey to the patient all the more complicated and demanding new measures to prevent contamination. As a result, packaging will play a vital role in the debut of potentially lifesaving drugs and will need to be a core consideration in the design and manufacturing process of these new products.
Anticipating the next generation of parenterals
Considering the potential hazards facing parenterals throughout production and distribution, it may be surprising to learn that the market today still widely uses ampules—small glass vials—to store and transfer medications. These containers, while offering an appealingly low cost, are susceptible to breakage. If glass particles fall into the drug as a result, the formula may be subject to cause contamination or harm.
On the other side of the spectrum sit prefilled syringes and cartridges, which offer arguably safer transport but have not yet gained traction due to cost and a more complicated design. This type of packaging component, while providing a high-value option with little risk, represents the smallest footprint in the current market.
Yet, the pendulum may swing as the pharmaceutical industry continues to evolve. As a whole, the prioritization of risk reduction at point-of-use is driving the need for packaging components that enable more fool-proof drug delivery—especially when it comes to self-administered medications. The fewer the steps required, the lower the chance of error.
As a result, personalized medicine is expected to become much more popular and present in the market, as drugs can be designed for more simplified administration and still maintain the necessary level of safety and control. This growth will likely boost the need for prefilled syringes and cartridges—devices that offer one-step use that are easier for both health professionals and patients to navigate. Accompanying these devices will likely be a rise in digital health apps and other technologies that can simplify drug use and self-administration. The result? An increasing need for higher-value components.
Addressing the changing demands of parenteral packaging
While the adoption of personalized medicines may simplify product use for the patient, these higher-value components also make the manufacturing process more complex. Designing drug delivery to be virtually fail-safe for patients requires an intricacy of safety measures throughout the product packaging.
When working with parenteral drugs in particular, it is important to be aware of potential hurdles posed by problematic packaging and to design production in a way that mitigates these risks. To start with, large-molecule drugs are often more sensitive to particle contamination than small-molecule drugs. This sensitivity can heighten the risk of contamination in the manufacturing process and ultimately render entire batches unusable, leading to major product loss and costs. It also makes the manufacture and packaging of larger batch sizes of drugs like biosimilars and biologics challenging.
This is where the role of packaging components, including sealing solutions, becomes particularly critical. The duty of packaging technologies should be to meet stringent requirements for safety and security throughout the manufacturing process and applying the appropriate sealing solutions to keep parenteral drugs sterile can make the difference in a viable batch. These solutions may take the form of elastomeric plungers—essential features for prefilled syringes, which aim to enhance safety and product integrity by reducing opportunities for error in administration. When designed effectively, plungers provide a smooth glide throughout the syringe barrel. This attribute enables chemical purity by reducing friction and enabling safe administration in manually- or pump-activated syringes—even after long-term storage.
It will be important for these components to modernize in response to the changing needs of drugs. The new characteristics and behaviors of future drugs will dictate new considerations and requirements in drug packaging. As demand increases for large-molecule parenteral drugs, which exhibit significant sensitivity to leachables and other particle contamination, manufacturers can benefit from new innovations in spray coating technologies that enhance the protective barriers of plungers and stoppers. By completely covering such components with a proprietary fluoropolymer spray coating, manufacturers can reduce drug contact with the naked rubber and leachables as well as other external contaminates to better protect formula integrity.
Yet, the trick is not to simply utilize the right components but to also engage the right partner in the implementation of those components. COVID-19 has demonstrated the merits of decentralized supply chains and suppliers that bolster continuous manufacturing capabilities for drug manufacturers, shining a light on service and process—not just materials and component design. New supplier manufacturing capabilities will shape the industry’s ability to respond to public health crises and pandemics, and packaging partners that take an integrated approach to design can provide reassurance that foresight and precautionary measures were applied to each level of production.
Achieving a secure parenteral package
To prevent opportunities for contamination throughout production, pharmaceutical companies should work closely with component manufacturers that can accommodate a range of batch sizes and will approach packaging for every product with the same care and scrutiny. As many companies move toward a modular facility design, flexibility and meticulous attention on the component side will be increasingly instrumental in enabling efficiency. Focusing on component sterilization further upstream in the production process can reduce the manufacturing footprint in a parenteral packaging facility, which can be designed to eliminate the presence of identified contaminants and to meet the highest manufacturing standards. An adjustable setup also supports the use of automation along the production line to minimize the risk of human contamination.
In addition, pharmaceutical companies will find value in manufacturing processes that can customize packaging to address individual product needs. This is an important capability for complex parenteral drug devices like pump injectors—devices for which off-the-shelf components are often incompatible. In this sense, employing a tailored approach to device design serves as a major avenue for meeting safety and performance standards.
Agility along the production line may be helpful for preventing contamination and facilitating unique product needs, but it is also helpful for meeting changing market demands. Amid supply shortages for COVID-19 test kits, and speculation on potential shortages of important packaging components for vaccines or treatments, drug manufacturers should scrutinize the processes behind scaling up from development to production. They should take a moment to ask whether a sudden surge in demand would create shortages and capacity limitations in their output. If the answer is “yes,” the company should be aware that speeding product to market could result in damaging missteps.
Drug and device manufacturers can mitigate these issues with a few considerations when selecting packaging suppliers. First, select a partner that offers a sample kit or “starter pack” to drug manufacturers that supports easy scaling between development, validation and production. Ensure the partner has expanded, decentralized manufacturing facilities around the globe to meet distribution needs as demand swells.
Next, to harken back to the tailored approach, leverage a combination of batch and continuous manufacturing to provide crucial components in necessary volumes, and closely collaborate to design and quickly produce custom components for effective sealing. Finally, create a manufacturing methodology based around quality control to mitigate defective components that can threaten drug integrity—a fundamental requirement to govern growing operations.
As the market continues to evolve, it will be prudent for pharmaceutical companies to consider the types of parenteral products that will gain traction, their individual needs and where component manufacturing will require adjustment to keep up. Flexibility and customization will serve as important points of differentiation in this process, enabling emerging medicines to reach the patient and perform as intended. The priority for all pharmaceutical companies moving forward should be to engage a partner that can provide a unique manufacturing approach prepared to meet these industry demands—and that can be ready for anything.