Important Considerations for Sterile Injectable Drug Packaging.

The parenteral packaging market is set for strong growth in the coming years. Functionality, patient-centricity and close collaboration are some of the factors influencing successful design and manufacture in this sector.

The parenteral packaging market is projected to grow at 5.5% CAGR between 2021 and 2031, fuelled by chronic diseases and the rising demand for COVID-19 vaccines.1 The WHO reports that diabetes was responsible for 1.5 million fatalities in 2019 and, as such, the demand for insulin is on the rise for early treatment and medication.2 This is driving the growth in speciality parenteral packaging, particularly in the area of pre-filled syringe and autoinjector dosage forms.

Quantifying the market growth further and focused on patient-centric injectable formats, The Business Research Company predicts that the global injectable drug delivery devices market will grow from $39.93 billion in 2022 to $43.54 billion in 2023, at a CAGR of 9.0%.3
These self-injectable drug products provide the most adaptable device with a high precision of drug delivery and ease of use for the patient. Due to their complex nature, these biologic products require specialized packaging to ensure their safety, stability, and efficacy, meaning biopharma companies must also evaluate product packaging needs, while keeping an eye on the impact of packaging design on profitability and speed to market.

Product Packaging Considerations

1. Product Protection
The primary function of pharma packaging is to protect the product from damage and/or degradation caused by external factors, such as moisture, light, temperature and physical damage during shipping and handling. For injectable drug products, these issues can be considerable, given heightened drug product thermal stability requirements with often cold or ultra-cold storage and distribution conditions a necessity, together with specialist frozen packaging.

Traditionally, manually frozen packaging has been the industry method of choice and is typically aligned to clinical, or small volume, niche, drug products. However, with the latest advancements in technology, automated processing at low temperatures can now facilitate larger, commercial-scale volumes. This provides increased operational efficiencies, reducing quality and safety risks, accelerating speed to clinic during clinical development and, later, market commercialization.

When processing temperature-sensitive drug products and packaging in cold or ultra-cold conditions, consideration needs to be given to label adhesive and printing inks, as these can be impacted by the low temperatures. Thought also needs to be given to active/passive shipping solutions to guarantee product protection during distribution to the end user.

2. Compatibility: Safe and Inert Primary Packaging
With the primary goal being to develop high-quality, safe, and efficacious medicines to improve patients’ lives, during the drug development process, it is important for packaging materials to be selected carefully to ensure compatibility with the product and to identify any potential for product contamination that could affect product stability or efficacy. Therefore, the most critical aspect of primary packaging is for it to be as inert as possible so that it does not react with, add to, absorb, or allow external factors to change a drug product’s established safety, strength, quality, stability, or purity characteristics. The material must be chemically stable and not generate extractables and leachables (E&L), delaminate, or undergo other changes upon contact with the drug product.

A combination of risk assessment and analytical testing will determine the potential of contamination. For those outsourcing the sterile filling and packaging of their injectable drug product, an experienced contract development and manufacturing organization (CDMO) that has worked with a broad range of drug products will have historical documentation of E&L studies and be able to share its expert advice.

Patient Packaging Considerations

1. Patient-centric Design
Patient-centric design facilitates drug administration and supports patients’ adherence to a treatment regimen. Understanding patient pain points, obtaining feedback from clinical trials and human factor testing, then modifying packaging presentations to patients’ needs, is vital to help them live with, and manage, their disease.

In the biotech space, the ever-evolving area of drug delivery systems often triggers the need for more sophisticated packaging, with patient-centricity being key when dealing with self-administration of products delivered by different dosage forms, including vials, pre-filled syringes and autoinjectors.
The packaging of these medicines, particularly when thinking about scale-up for commercial launch, may require a technologically advanced, and often bespoke, packaging solution. For example, some autoinjectors now include wraparound devices aimed at improving the dexterity and grip of the patient.

2. Child Resistant/Senior Friendly
A prominent factor in packaging design is the development of child-resistant packaging, addressing global regulations and reducing the incidence of unintentional child poisoning. However, when developing child-resistant packaging, one of the greatest challenges is designing a closure that prevents children from gaining access to harmful substances but without limiting the ability of senior patients to take their medication. Increasing population age, combined with the growing trend for home care, is directing the focus of child-resistant packaging on to the accessibility needs of older patients, simultaneously.

Production Packaging Considerations

1. Manufacturability and Packaging Design
Early consultation between clinical and commercial stakeholder groups is important. Packaging design is a critical area of importance, so consideration of manufacturability is encouraged from the outset. Thinking about package design sooner in the clinical development process can lead to both cost- and time efficiencies, as the price of mistakes can be high.
Ensuring that the design and operational teams work together, using a design-for-manufacture philosophy, will help them understand the impact of design on packaging operations earlier in the process, ultimately delivering a streamlined and longer-term, time-efficient solution.

A common challenge arises when a biopharma company has its pack designed by a third-party design agency. This may meet the end user’s specification, but it may not fit on the packaging equipment itself when it comes to commercial manufacture. A designed pack that is not optimized for the packaging process equipment will result in unnecessary upfront capital costs, modifications to existing equipment and higher labor and commercialization costs, ultimately resulting in higher manufacturing costs and lowering commercial revenues.

Global Integrated CDMO Solutions

At PCI, ensuring life-changing medicines reach those who need them most is our highest priority. As a truly integrated global CDMO, we are manufacturing, packaging and supply chain experts, harnessing our experience and expertise to deliver seamless solutions with the ultimate aim of improving the lives of patients.
Providing expert sterile fill-finish and lyophilization solutions, from development to commercialization, together with integrated custom packaging solutions for sterile injectables, allows ultimate knowledge sharing and communication between teams to ensure the drug product packaging is optimized for the product, patient, and production.

PCI’s pharma packaging design department provides an innovative and value-added service to our clients. The dedicated team of in-house design specialists delivers insightful packaging design and practical knowledge to provide differentiated and cost-effective packaging solutions. Using three-dimensional modeling, we are able to facilitate rapid prototype design to support patient and physician focus groups, yielding vital insights into patient usability and acceptability. This also supports regulatory filings, providing an expedited response to enable true speed to market.

Meeting the growing needs of our clients for their life-changing biological drug products, PCI continues to invest in both our manufacturing and packaging capacities and capabilities. Over the next 12-18 months we have planned significant investments to expand upon our global clinical and commercial biotech packaging service offering for injectable drug delivery device combination products.
These investments reflect the outlook and the market opportunity that the company envisages for the future of injectable drug products. As a leading global CDMO we not only want to meet growing demand for scalable biotech packaging, but, through innovative value-add solutions, we aim to exceed customer expectations, delivering flexibility and excellence in all that we do to accelerate the development and commercialisation of life-changing therapies.

References

1. Visit: www.futuremarketinsights. com/reports/parenteral-packagingmarket
2. Visit: www.who.int/news-room/factsheets/detail/diabetes
3. Visit: www.researchandmarkets. com/reports/5733800/injectabledrug-delivery-devices-global-market

Important Packaging Considerations for Sterile Injectable Drug Products – Pharmaceutical Manufacturing and Packing Sourcer | May 2023 .


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Our dedicated team of specialists will be happy to discuss any of your Sterile Injectable Drug Packaging needs. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com

Pharmaceutical Manufacturing and Packing Sourcer | May 2023