Injecting Innovation into Drug Packaging

It is estimated that the pharmaceutical packaging market will experience growth at a compound annual rate of 6.1% during the forecast period of 2020–2027 (1). This growth is accompanied by changes in technical requirements and market demands that are driving opportunities for innovation.

According to Jens Kürten, group senior director, Communication and Marketing, Gerresheimer, there are nine megatrends that will both characterize and influence the pharmaceutical packaging market. “[These trends are the] rise in chronic conditions and an aging population, rapid growth in generics, better healthcare provision in emerging markets, growing urban populations and middle classes, rising costs in healthcare and stricter regulatory requirements, more biosimilars and biologics, self-medication and personalized medication, growth trend in vaccinations, and sustainability,” he asserts.

Market influences

“Pharmaceutical packaging requirements are influenced by the increasing need for patient self-administration and the increasing number of biological therapies, including cell and gene therapies, as well as the latest developments in COVID-19 vaccines,” says Janina Lehmann, senior director of Technical Customer Support, North America and Europe at West Pharmaceutical Services. Therefore, companies are seeking solutions that are more advanced and ready-to-use, so that the drug product quality, safety, and efficacy are protected, she explains.

When approaching packaging solutions for injectable drug products, Lehmann continues, it is important to achieve good compatibility with the primary container. “New technologies are improving drug stability and minimizing drug/container interaction during shelf life,” she notes. “High-quality container closure systems that meet regulatory requirements reduce the risk of leachables, provide container closure integrity, and minimize particulate risk.”

For Fabian Stöcker, vice-president, Strategy and Innovation at Schott Pharmaceutical Systems, there is an increasing trend towards unique packaging solutions due to the rise in distinctive drug formulations being developed. “There is simply not a ‘one size fits all’ approach that is feasible when considering the various aspects that must be fulfilled to safely store and administer drugs,” he says. “These requirements are determined, among others, by the drug product; for example, a highly sensitive drug will need a primary packaging that reduces drug/container interaction.”

The route of administration also plays an important role, Stöcker emphasizes. Whether the drug be injected intravenously or subcutaneously, at home or in a hospital setting, there are various needs that should be considered prior to choosing the ‘best-fit’ packaging, he adds. “Moreover, packaging requirements for pharmaceuticals change over time as the lifecycle of the drug continues,” Stöcker states. “In most cases, a new drug (e.g., a COVID-19 vaccine) is introduced to the market in a vial. In the mid- to long-term, most drugs then shift to prefillable syringes to simplify routes of administration among others.”

A rise in demand for therapies that can be administered by the patient themselves and the expanding biological therapy pipeline are driving innovation in both containment and delivery of injectables, Lehmann specifies. Continuing innovation in primary packaging solutions that are in line with serialization will also help to improve supply chain transparency and combat counterfeiting, she says.

From the machine manufacturer’s perspective, Andreas Mattern, director Product Management Pharma, Syntegon (formerly Bosch Packaging Technology), reveals that the most significant changes impacting packaging equipment are mainly due to the requirement for smaller batch sizes. “[These batch sizes command] faster changeover from one product and one packaging style to another, requiring highly flexible equipment, [while] operators and products [must be protected] from each other to avoid contamination, especially in primary packaging,” he says.

Strong demand is being seen for comprehensive turnkey projects, adds Jan Deininger, group communications manager at Optima Packaging Group. “Projects are often realized using a turnkey manufacturer for fill/finish, the isolator technology, and, if required, also for freeze-drying,” he says. “In the area of fill/finish, robotics is also being used more frequently. Digitalization continues to offer great potential for a further increase of production reliability in pharma.”

Overall, pharmaceutical packaging requirements are increasing, stresses Stuart Brown, business development manager, Sanner Group/Sanner of America. “Packaging solutions should be simple and have a high usability. They must protect the content and, in the best case, also provide intelligent functions to enhance patient adherence,” he notes. “Moreover, customers request more eco-friendly options to reduce or avoid plastic. They are also interested in the sustainability strategy of the producer.”

Pandemic demands

“The COVID-19 pandemic presents a unique challenge to global health and has strongly increased the demand for vaccines and therapies in health clinics,” Lehmann says. “Vaccine manufacturers and biotechnologies companies are developing COVID-19 vaccine candidates using different technologies such as mRNA, DNA, protein, and viral vectors. Each vaccine has different requirements for storage, preparation, and administration.”

As a result, it has been necessary to design the packaging for the vaccines with these specific requirements in mind to ensure the safety and efficacy of the therapeutic product are protected. “Several of [the COVID-19] vaccines require storage at ultra-cold or cold temperature, and multi-dose preparation,” Lehmann continues. “Advanced packaging solutions tailored to sensitive biologics such as nucleic acid and protein vaccines are reducing development risks and accelerating path to market. Agility in vaccine development, including the container closure systems, is essential to COVID‑19 treatment, while maintaining quality and safety. Speed and efficiency in parenteral drug development will remain post the COVID-19 pandemic, and pharmaceutical companies will benefit from a more robust supply chain.”

Pharmaceutical packaging was already experiencing steady growth for a number of years prior to the COVID-19 pandemic, reveals Stöcker, particularly for companies like Schott that produce the standard borosilicate glass vials, which are currently needed for vaccines. “Relying on standard containers and proven materials [such as borosilicate glass vials] has allowed the industry to speed up many processes,” he says. “It also appears that the pandemic will have an effect on the packaging market for some years to come, as vaccine booster shots will likely be needed each year.”

Gerresheimer, which also produces borosilicate glass vials, had similar experiences to those elaborated on by Stöcker. “[The year] 2020 was marked by the outbreak of the COVID-19 pandemic, which heightened awareness and increased the significance of a functioning healthcare system, good provision of drugs and medical technology, as well as access to preventive healthcare,” continues Kürten. “In particular, vaccinations have come to the fore as a key means of preventing infectious diseases. Our products, especially vaccine vials made from borosilicate glass, are playing a major role in the preparation and implementation of COVID-19 vaccination campaigns.”

Both Schott and Gerresheimer have confirmed increased investment in production capacity to account to the rising demand of vials for vaccines, which Kürten highlights will continue beyond the COVID-19 pandemic as more people take up vaccinations of all kinds. “The importance of vaccines and injectables will increase, with annual growth rates of 6–10%,” he says.

There has also been an increased demand for filling and closing lines with high output for COVID-19 vaccines, adds Deininger. “Great efforts have been made to adapt existing filling systems for vaccine filling and to build new filling systems as quickly as possible,” he states. “The vaccine lines were designed with high output rates, high filling accuracies, and isolator technology.”

For Mattern, demand for over-the-counter drugs and nutritional supplements, formulated as tablets and capsules, rose during the pandemic, in addition to a strong increase in demand for injectables. “[As injectables] are typically packaged in vials, most of the initial demand was met by repurposing existing equipment, but especially for the vaccines, we assume there is going to be a lasting demand for additional processing and packaging capacity,” he says.

“COVID-19 has changed the typical working day of everyone involved in pharmaceutical packaging—from the drug producer and contract packer to the packaging supplier and the equipment manufacturer,” Mattern asserts. “We have all experienced the need for faster delivery times of our core products (drugs, packaging, and equipment).”

Opportunities for growth

Optimization of production will be a key focus for packaging producers in 2021, reveals Brown. “[In 2020], many new capacities were built up, partly from scratch, to fulfill the increased demand,” he says. “When things settle back to normal again, we need to align the old and new capacities and identify potential for optimization in automation and digitalization, but also in performance and energy efficiency. At the same time, new solutions that are still in the development pipeline due to COVID-19 will be pursued and hopefully launched in 2021.”

The acceleration in demand for production and packaging of therapies that has been experienced as a result of COVID-19 has provided tremendous opportunities for contract manufacturers, Mattern specifies. “The strong innovation and continuous development of the drug pipeline by originators will certainly lead to future opportunities for outsourcing, especially if [contract manufacturing organizations] CMOs install flexible, ‘future-proof’ equipment,” he asserts.

Automation and digitalization are major trends for stakeholders in the pharma industry but also pose challenges. “Digitalization will still take its time due to the strict regulatory and validation requirements in the pharmaceutical industry,” Mattern notes. “However, the use of robots is currently increasing in filling and packaging operations, which is another step in the right direction since, according to US FDA statistics, human errors are responsible for approximately 50% of process deviations” (2).

In terms of the current market, Stöcker highlights that opportunities are becoming apparent to companies like Schott, as providers of both glass tubing and pharma packaging, because it is easier for capacities to be adjusted ad hoc. “Another opportunity we see is the rise of packaging made of high-quality polymer, precisely cyclo-olefin-copolymer,” he says. “The material has established itself as a suitable alternative for specific drugs and applications.”

There is also an increasing need for pharma analytics, which is creating both opportunities and challenges for packaging companies, Stöcker continues. “Chemical stability studies and E&L [extractables and leachables] profiles are becoming ever more important with new drugs entering the market. By working together closely with drug manufacturers, pharma packaging companies can leverage their knowledge to offer the best fit packaging for each unique formulation,” he explains.

“Special primary packaging needs for highly sensitive drugs, such as biopharmaceuticals or biosimilars, the increasing concern for supply chain security, and the need for patient self-administration represent growth areas and opportunities in the packaging market and are driving innovation,” Lehmann asserts. “From complex drug development to regulatory scrutiny, and from changing standards to drug–device combination products, pharmaceutical companies must address and work through many considerations related to packaging. Partnering with a packaging technology supplier who can demonstrate the suitability of the packaging system for its intended use early in drug development, will help to reduce development time and supply risk and minimize total cost of ownership.”

A sustainable future

Sustainability is not simply a corporate obligation but a potential growth driver, states Kürten. “The next 5–10 years will be more about sustainability than ever,” he says. A key target for Gerresheimer is to ensure that by 2023 and beyond all newly developed products will comply with ecodesign principles.

Mattern concurs that sustainability will be a main trend, particularly for secondary packaging, in the coming years. “The challenge for packaging manufacturers will be to develop [more sustainable] solutions that match the stringent regulatory requirements in terms of safety, processability, and barrier properties for pharmaceuticals,” he adds.

Even though significant advances have been made in sustainable packaging options, such as all-paper solutions and bio-based materials, the pandemic has led to delays, in some cases, of uptake and implementation. “The trend towards more sustainable pharmaceutical packaging solutions has also been hindered by the lack of pharmaceutical compliance,” Brown notes. Furthermore, increased development efforts need to be made by raw materials suppliers to provide new materials that are suitable for use with pharmaceuticals, he asserts.

Considerations over recyclability of materials is also necessary, Brown continues. “For example, multi-layer materials are difficult to recycle, so, we need to consider recycling aspects more when developing new packaging solutions,” he says. “Adjustments to pharma compliance regarding sustainability efforts, such as the development of compliant sustainable materials, must and hopefully will come.”

“With a growing focus on environmental sustainability, pharmaceutical companies are exploring new ways to design products that can be recycled or reused and new ways to minimize consumption and waste in manufacturing,” confirms Lehmann. “The pharmaceutical industry is working with packaging technology suppliers toward this goal. Continuous collaboration between pharmaceutical companies and packaging technology suppliers is important to protect quality and safety of the drug product and to create a healthier environment during and post the COVID-19 pandemic.”

For Stöcker, sustainability is also an important issue for the future, with various initiatives already underway across the whole industry to achieve sustainable goals.

Other trends

Another key trend for pharmaceutical packaging is the increasing complexity of drug formulations, which is driving the need for analytics, Stöcker highlights. “In many cases, these new complex drugs enter the market in smaller batches as the patient group is smaller than with blockbuster drugs. This is where we see great potential for ready-to-use containers,” he says.

Ready-to-use containers are trending, Mattern agrees, with more equipment available to provide the flexibility required to process presterilized syringes, vials, and cartridges. “There will always be a need for ‘runner machines’ processing drugs at high volumes and low cost,” he states. “But for the emerging medicines with lower production volumes, the need for flexibility in both packaging container and lot size will, in many cases, be of a higher priority than optimized costs.”

Personalized medicine and novel therapies are impacting the pharmaceutical industry in general, asserts Deininger. “[These] drugs represent a particularly high financial value and are complex to produce, which challenges the filling technology in various ways,” he says. “Also, the share of approved drugs to treat rare or ‘orphan’ diseases has increased. This also influences the requirements for filling and closing machines. Small batches require high system flexibility as well as fully automated and fully safeguarded processes. Under these conditions and with these technologies, even small, very valuable batches can be processed very efficiently.”

“Packaging development has become an integral part of pharmaceutical drug development and manufacturing. The increasing need for ready-to-fill container closure systems compatible with different, modular filling lines will further drive packaging innovation,” Lehmann summarizes. “The COVID-19 pandemic has strengthened the collaboration between the pharmaceutical industry, packaging technology suppliers, and regulatory authorities, creating a solid network for speed and efficiency in development and supply of safe and effective medicines in the future.”

References

1. Allied Market Research, Pharmaceutical Packaging Market by Product Type (Parenteral Containers, Plastic Bottles, Blister Packaging, Closures, Specialty Bags, Labels, and Others), Material (Glass, Aluminum Foils, Plastics and Polymers, Paper and Paperboards, and Others): Opportunity Analysis and Industry Forecast, 2020–2027, Market Research Report (January 2021).
2. R. Friedman, “Risk Reduction, Reliability, and Sustainability: The Drivers for Modernization of Sterile Manufacturing,” presentation at the 2021 ISPE Aseptic Virtual Conference (March 15–17, 2021).

About the Author

Felicity Thomas is the European editor for Pharmaceutical Technology Group.

Article Details

Pharmaceutical Technology
Vol. 45, No. 5
May 2021
Pages: 16–19, 23

Citation

When referring to this article, please cite it as F. Thomas, “Injecting Innovation into Drug Packaging,” Pharmaceutical Technology 45 (5) 2021.