プレフィルドシリンジ：考慮されていないかもしれない３つの問題点

Pain Point #1—Process Development and Optimization

Building out an optimal and flexible process design is necessary for long term success. Getting any sterile product to market can be quite lengthy, so a scientifically sounded process development design and further optimization is a key milestone. It’s important to focus on this once initial information about drug products are collected during early development in order to set your prefilled syringe up for commercial success.

Solution #1— Process Development and Optimization That Fits Your Unique Needs

Every molecule has unique attributes and processes that don’t fit into cookie cutter models. To achieve high quality and sustainability within your product’s life cycle, building out a robust process with agility and flexibility will set you up for long term success as you scale. It’s important that your partner has industry experts and the experience to develop an optimal process that is tailored to your unique challenges and needs. For example, here’s a checklist of things to look at:

• Formulation development
• Syringe and plunger screening
• Mixing and pump-shearing studies
• Holding time studies
• Mechanical or vacuum stoppering studies
• Nitrogen purging or flushing
• Sterilization cycle development and validation
• Gliding and break-loose force studies
• Shipping studies
• Scalability studies

Furthermore, when it comes to process development and optimization, it is crucial to recognize the value of having a development site with commercial capabilities—or more simply put, having the product’s entire journey “under one roof.” This provides drug manufacturers an easier process to transfer and scale up their product from development to commercialization.

Pain Point #2—Regulatory Preparedness

When it comes to steriles and specifically syringes, the market is highly regulated and always challenging. As a result, many companies don’t have the internal resources to stay on top of the ongoing regulatory filings and process requirements necessary for their prefilled syringe project. If your plans are to expand globally, not having that expertise of global regulatory bodies can cause frustrations and setbacks. Whether you are currently at a local scale or global scale with your current product, not being able to have a strong focus on the regulatory components can cause lengthy delays and result in negative financial implications to your project.

Solution #2—Find a CDMO with a Strong Regulatory Reputation

When considering a CDMO to partner with for your prefilled syringe program, inquire about their experience with local and global regulatory authorities and governing bodies. At the same time, it may only be relevant to look at the current country you’re doing business in. However, it is important to look beyond this because eventually your product will scale globally. Important questions to consider when selecting a CDMO include:

• Do they have a clean track record?
• What does their global regulatory experience and resources look like?
• How familiar are they with regional regulatory requirements and governing bodies?

Whether you’re in early development or commercialized manufacturing, this common oversight in CDMO selection can negatively affect your prefilled syringe program—making a CDMO with a robust means of overseeing regulatory matters crucially important.

Pain Point #3—Demand Planning and Forecasting

Demand planning and forecasting is critical to your success; however, it can be difficult to manage because there will be uncertainty with many factors. Let’s say your prefilled syringe drug product unexpectedly takes off in popularity. Doctors are reaching out one after another because you’ve created an incredibly life-improving, easy-to-administer drug product, and you just can’t keep up with the demand. Lacking long-term foresight is common and for many operations, is something that’s hard to predict. If you over or under forecast, it can not only have a huge financial impact, but also impact the well-being and lives of patients who are dependent on your product.

Solution #3—Find a CDMO with a Strong Demand Planning and Forecasting Reputation

Since demand planning and forecasting is vital to your prefilled syringe program, it’s important to embark on a journey with a CDMO who has a strong reputation of navigating this critical and challenging process. It’s also important to find a CDMO who can offer versatile and flexible solutions that can be easily adapted to fluctuate with market demand—they should have the ability to provide multiple lines of support for differing manufacturing scales. As a result, this will ensure that you are managing costs, resources, and time efficiently, while ensuring your product reaches patients.