Packaging expert Alexander Schäfer suggests that a comprehensive approach to packaging should involve three key elements. These elements are analyzing market trends, understanding consumer expectations, and considering partnering with a pharmaceutical contract manufacturing organization (CPO).
By analyzing market trends, businesses can gain insights into what packaging designs and materials are currently popular. Understanding consumer expectations allows businesses to create packaging that meets their needs and preferences. Finally, partnering with a CPO can provide businesses with the expertise and resources needed to efficiently and effectively package their products.
Utilising Pharmaceutical Contract Manufacturing Partnerships
When launching new drugs to a global market, there are many different factors to consider to ensure a successful packaging strategy. Labeling, kitting/packing, serialization, and distribution channels must be efficient and secure. Packaging designs must be end-user friendly and appeal to all markets, while also taking new sustainability requirements into consideration. And, importantly, you must provide ingredient details and dosage instructions in local languages.
A deep understanding of regional differences in regulations and marketing is critical for global launches. One difference between launching in the EU and the US is the need for late-stage customization in secondary packaging.
The simple reason is that one stock-keeping unit tracker (SKU) is sufficient in the United States, whereas up to 27 different SKUs might be required in Europe for the same drug. Additionally, there are inherent complexities tied to an EU launch as it relates to native serialization and aggregation.
Current market trends in packaging services
Biologics are impacting packaging trends for drugs in the market and in development. Small-molecule drugs are less likely to outsource them. This information comes from a new report by GlobalData.
The need for vaccines and injectable treatments is still high after Covid-19. The pandemic increased demand and showed how important it is to have secure packaging for injectable medicines.
In 2022, a lot of injectables were approved for use. 841 injectables got their first approval last year, according to GlobalData’s latest research. The trend is continuing. In August 2023, the number of approved injectables increased by 516 compared to the same period in 2022.
More injectable medicines are being approved, so there is a higher demand for prefilled syringes and auto-injectors. People like auto-injectors because they are easy to use and make them happy. This trend is expected to continue in the future. This also has implications for technical packaging requirements, design, and patient safety instructions.
Big pharma companies often support new injectable treatments and hire external packagers for packaging tasks, as shown by the data. Only a small number of pharmaceutical contract manufacturers in the bio/pharma industry offer injectable packaging solutions.
New product launches in drug development
Alexander Schäfer is a Business Development Manager at Sharp. Sharp has been offering packaging solutions for pharmaceutical and biotech products since the 1950s.
Setting up for a successful new drug launch doesn’t just involve labeling, packaging, and distribution channels, Schäfer says.
“A strong project management approach is essential for supporting commercial scale packaging design through post-launch production to ensure key milestones are achieved on time through the entire process,” Schäfer explains.
Project management is crucial for a product’s entire lifespan. This is because market changes, such as regulations or requests from the drug sponsor, can result in various modifications. These modifications may include changes in packaging, serialization, or even the introduction of a new delivery system for injectables. Even small amends require a diverse team of experts to implement them, and efforts must be prioritized, assigned, and managed properly to meet amendment deadlines.
Schäfer points out that understanding a drug’s technical and design requirements as it relates to packaging is crucial for successful rollouts, whether it is a single SKU operation or a global launch requiring operational agility and regulatory expertise support.
Whether drug sponsors are experienced in new product launches or not, they may seek the expertise of contract packagers to efficiently support a new product launch.
“Experienced packagers can provide input on designing cards and packing leaflets,” adds Schäfer, “but true partnership and collaboration is critical for a successful commercial launch.” Drug sponsors must be able to provide insights, for example, on the drug’s occupational safety and health data, packaging design constraints and specification challenges. In turn, packagers offer customized design and operational solutions to support an efficient launch.
In addition, a contract packaging partner should not only focus on the immediate drug launch project but also look to understand and collaborate on long-term strategies including additional market introductions, scheduled label changes, process improvements, more sustainable packaging solutions or even delivery system evolutions. By collaborating in this way, the CPO can offer valuable suggestions and recommendations early in a project that could help save time and money further down the road.
Drug launch and late-stage customization
A drug launch follows regulatory approval, where manufacturing services are utilised through to distribution must align to supply a new therapy to patients as quickly as possible. For packaging, there’s significant preparation leading up to a launch date.
In some instances, especially for new drug launches in the US, it is important to consider a ‘materials on risk’ program. Here while awaiting regulatory approval, bulk product and components are available in inventory, documentation from all stakeholders is finalized and packaging production lines are engineered and made ready to go. This approach requires a combination of risk-taking and micromanagement but can set the stage for a successful rapid launch immediately following regulatory approval.
A multi-country launch is more complicated because each country requires native labeling and packaging. Late-stage customization is a solution that involves streamlining artwork design and packaging operations to ensure the agility needed for a multi-country launch.
“It’s basically a solution for making a product country-specific,” says Schäfer. “For instance, labeling and packaging on demand.” The objective is to leave final customization of a product to a ‘last minute’ point of time within the supply chain. This gives inventory flexibility for any potential variations in forecasts across multiple countries during launch phase.
An innovative approach to serialization
There are several differences between the US and EU in terms of serialization and aggregation. Last minute changes, such as moving from vials to injectables, can be difficult to implement.
When selecting a contract packager, it is important to understand their experience level with global serialization requirements. During the selection process, it is necessary to ask questions relevant to your growth strategy and to ensure you are selecting a partner that can support your long-term objectives.
The right packaging and serialization partner can easily adapt the existing “blueprint” system, that has been customized for your product, to meet the needs of future launches into other markets. This is an important cost and time saving consideration, and it is best to include aggregation from the start of a program rather than add it as a post-launch requirement.
Schäfer explains that to effectively tailor packaging solutions, it is crucial to consider the big picture and ensure that both software and hardware are flexible enough to handle specific drug product needs.
This includes considering different packaging technologies and handling processes for different purposes, such as vaccines with large volumes and multiple count packs, or single pack gene therapies with on-demand packaging that require specialized cold chain storage and distribution.
It is also important to have a strong and experienced design team available to support packaging artwork development and structural design as well as prepare samples, 3D prints, and mock-ups for discussions with marketing teams.
Schäfer says Sharp has adapted to industry changes throughout its history by investing heavily in packaging facilities, technology, and subject matter experts to meet industry and client demands.
The company is also offering packaging support in the gene therapies space, which is a new area of focus. Environmental sustainability, which has become a significant issue industry-wide, is now a key focus for Sharp both in terms of its own operations as well as client expectations for sustainable packaging solutions and processes.
For customers, Schäfer says expertise is crucial, especially for smaller to medium-sized biotech and pharma companies, who may lack in-house resources. “Clients expect peer-to-peer discussions on specific topics, technologies, and regulatory discussions, requiring up-to-date knowledge and experience,” he concludes.
Partnering with Sharp
Sharp’s expertise extends to state of the art packaging solutions for on-demand labeling and distribution services, supporting patient-led distribution models for gene therapies, and injectables requiring multi-component secondary packaging and drug life-cycle management strategies.
In the highly competitive secondary packaging market, Sharp shines as a leading name, recognized for its exceptional manufacturing capabilities. With a commitment to excellence, Sharp’s expertise extends seamlessly from aiding pivotal clinical trials to supporting the complex needs of drug manufacturers. Their collaborative efforts bridge the gap between cutting-edge research and efficient production, making them an indispensable partner for both research and manufacturers alike.