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Catering to an Expanding Parenteral Drug Market

How drug manufacturers can adapt packaging for injectables to meet evolving patient needs

Massimo Mainetti, Global Head of Marketing and Product Management, Datwyler

Pre-pandemic trends can feel like a distant memory, but prior to the onset of the Coronavirus, demand for parenteral drugs was already on the rise. In 2018 alone, there were nearly 500 parenteral drugs in the pipeline. The spread of COVID-19 only exacerbated this growth as drug developers worked tirelessly to produce a vaccine. Considered one of the most efficient drug delivery techniques, parenteral drug delivery can help achieve easier administration, advanced safety, more accurate dosing, and a minimum risk of contamination. Following oral solids, parenteral administration is the most common form of drug delivery.

However, manufacturing parenteral drugs—especially large molecule drugs—often comes with significant challenges. Formulations can be highly sensitive to potential contaminants, requiring greater resources, and time to manufacture and package. These complexities can make scaling up production to match demand particularly arduous. However, drug developers and manufacturers can anticipate these hurdles and better identify the right parenteral drug packaging solutions to protect formulation integrity, ensure efficient delivery, and improve adherence.

What Makes Parenteral Drug Administration the Preferred Option?

A few factors continue to drive the expansion of this market, including the increasing need for COVID-19 vaccines available around the globe. As new variants emerge and still a long way to go towards reaching global herd immunity, vaccine developers are exploring new delivery methods for their vaccines, including prefilled syringes. While vials have been the standard in COVID-19 vaccine packaging, prefilled syringes are the logical next step due to ease of administration, reduced risk of contamination, minimised risk of injuries during use, and improved accuracy.

Amid a pandemic, medical professionals are looking for alternative ways to treat non-COVID patients without the need for a hospital visit whenever possible. Parenteral drug delivery devices like auto, wearable, and pen injectors can allow patients the convenience of receiving treatment in the comfort of their own home. Especially in the case of large volume parenterals that require a large amount of medication to be delivered, wearable devices can help patients receive consistent dosing that better integrates into a patient’s lifestyle. Prior to the outbreak, the self-injection device market was already valued at $34.4 billion and projected to reach $228.84 billion by 2027.

At-home care which is often needed for a patient’s comfort and is more cost effective, presents an opportunity for medical device and drug manufacturers to adapt to the ever-evolving industry with custom solutions to address unique needs and meet rising patient expectations. To achieve market differentiation, manufacturers must develop custom, patientfriendly products that not only support the efficacy of the treatment but also offer convenience, support compliance, and most importantly, ensure safety.

Understanding and Overcoming the Hurdles in Parenteral Drug Packaging

Unlike oral drug treatments, injectable biologics are developed from less stable, large molecules, making them more susceptible to contamination, more difficult to manufacture and often, more costly. They can be incredibly sensitive to contaminates such as silicone, cellulose, and airborne particulates. Should contamination occur, the entire batch must be disposed of, prompting developers to take extra preventative measures to protect formulations.

Though packaging may seem like secondary components to drug products, it can significantly impact the efficacy of a treatment. Despite the numerous industry-standard quality audits and third-party oversight, parenteral drug contamination is common. In fact, because parenteral drugs like injectable biologics are at greater risk to foreign contamination, the category has been met with numerous cases of protein aggregation, silicone sensitivity, loss of efficacy, and recalls.

What makes injectable biologics even more difficult to package is the higher immunogenicity risk to patients, which requires more stringent quality control for primary packaging solutions. This potential threat compels drug developers to ensure that manufacturing environments not only meet the more rigorous regulatory and quality demands, but also eliminate variability in the pharmaceutical packaging.

While the industry also continues to produce patient-centric treatments in formats that simplify both healthcare professional and patient use, the manufacturing process becomes more and more complex. With this shift, drug developers become tasked with delivering a virtually fail-safe drug delivery system for patients which require intricate safety measures for the product packaging. In the midst of these hurdles, the role of packaging components and sealing solutions is crucial.

Mitigating Drug Contamination: Prioritising Parenteral Packaging Components

By ensuring the quality of essential packaging components, drug developers can mitigate the risk of seeing entire batches of drugs rejected from the marketplace due to formulation impurities, or worse, in a recall. For highly sensitive drugs, drug developers can equip any plunger or stopper with full coverage of a no-silicone added fluoropolymer coating. This can create a robust barrier between the drug and rubber that ultimately minimises the impact posed by extractables and leachables.

Additionally, drug and device manufacturers can seek ready-to-use components in rapid transfer port (RTP) bags so that drug manufacturers do not also have to stretch themselves thin by sterilising components. Typically, stoppers are steam sterilised by the manufacturer, whereas plungers are supplied to the customer ready-to-use (in combination with ready-to-fill syringes packaged in tubs) using gamma irradiation. With more filling lines being developed to process ready-to-fill vials, cartridges, and prefilled syringes, the demand for ready-to-use stoppers and plungers is growing every year, and with more demand comes more variety in how these components are processed and sterilised by the pharmaceutical company.

Ensuring that elastomeric components undergo 100% camera inspection adds another layer of security that human eyes alone cannot achieve. When using camera inspection, one can ensure that the packaging used in these critical devices is meeting the level of quality demanded for parenteral drugs. If a component that is inspected manually has a defect – it can result in a high cost if an entire batch of drugs are rejected. Camera inspected components help drug manufacturers avoid this risk, potentially streamlining production and saving what would be a costly error.

Finally, drug manufacturers should maintain an open channel of communication with their packaging component suppliers. With transparency, specifiers can easily identify and trouble-shoot potential sources of contaminants and eliminate common defects throughout the supply chain, detecting potential issues earlier rather than much later in the distribution stages.

Every Detail Matters

As the industry continues to evolve with changing patient needs, parenteral drugs become more prominent, requiring drug developers to be flexible in order to meet growing demand. As we’ve seen with various COVID-19 vaccines, it is essential for pharmaceutical companies to have the necessary packaging available when operating on accelerated timelines because of an unprecedented surge. While packaging may seem like a small detail in the grand scheme of a treatment, it can mean the difference between helping secure a drug’s efficacy or rendering it useless. It is in these moments that it becomes essential to partner with suppliers that ensure the utmost quality in the packaging components that enable these treatments to reach patients safely.

DATWYLER

Datwyler is focusing on high-quality, system-critical elastomer components and has leading positions in attractive global markets such as healthcare, mobility and food & beverage. With its recognised core competencies and technological leadership, the company delivers added value to customers in the markets served. With more than 20 operating companies, sales in over 100 countries and more than 7,000 employees Datwyler generates annual sales of more than CHF 1’000 million. Within the healthcare solutions business area, Datwyler develops, designs, and manufactures solutions for injectable packaging and drug delivery systems to facilitate customers to create a safer medical environment of tomorrow. Looking back onto more than 100 years of history, Datwyler is a reliable partner, now and in the future! www.datwyler.com

--Issue 45--

Author Bio

Massimo Mainetti

Massimo Mainetti holds a master degree in business administration from the University of Milan. He started his career in a finance firm in London. A few years later, in 2003, he joined Panasonic Industrial Europe as Key Account Manager and then moved to a Distribution Manager role. In 2008, Massimo Mainetti assumed the position of Strategic Key Account Manager at Becton & Dickinson within the Pharmaceutical Systems business unit. In January 2015, he joined the global sales team of Datwyler Pharma Packaging as Key Account Manager Injection-Systems. And since June 2017, he has been acting in his current position.

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