West can partner with you to get your product to market faster while mitigating risk

EU MDR, Annex I Guidelines Compliance Challenges

If you are like many other newly formed biotech companies, you're doing your best to manage many activities critical to your success with limited resources, all while trying to accelerate your path to market.

EU MDR, Annex I Guidelines Compliance Challenges

You need guidance early in your development so you can avoid mistakes that could cost you extra time and money later in the process.

Challenges in Drug Development

Traditional Packaging Components aren’t Appropriate for Complex Drugs

Ensuring Expedited Speed to Market

Speed to market can determine the success of your product. Emerging companies take, on average, two years longer than established companies to get drugs to market.1 Understanding the importance and implications of packaging decisions early in your process can reduce risk to your program and prevent delays to market.

¹Emerging Biopharma’s Contribution to Innovation, June 2022, IQVIA

Traditional Packaging Components aren’t Appropriate for Complex Drugs

Staying Updated with Regulatory Changes

Constantly changing regulations and increasing scrutiny around quality requirements adds complexity. Do you have the expertise to interpret these regulations and guidance to avoid compliance challenges?

Traditional Packaging Components aren’t Appropriate for Complex Drugs

Managing Limited Resources

Are you having trouble determining where you need to focus your team? With a leaner organization it’s important to make efficient use of your limited resources.

Are you facing these challenges?
Learn more about containment solutions to mitigate risk and help you get your drug to the patient faster

Five Key Considerations for Component Selection

1

Start Packaging Development Early

By obtaining information and proactively mapping out your approach early on to better understand the decisions you need to make around your fill/finish strategy, you can avoid the risk of making an investment in equipment or processes that may not meet your long-term needs.

2

Establishing a Container Closure System

Container closure systems should maintain the sterility and quality of final drug products throughout their shelf life. Therefore, it is critical to find components that will work as a system, fitting dimensionally together, to ensure container closure integrity.

3

Protecting Your Drug Product

Interactions between drug product and components can impact the safety, efficacy and shelf life of your product. It is important to select components that will protect, store and deliver your product to the patient.

4

Minimizing Particulate Risk

Subvisible particulate continues to be a significant patient safety concern and is the subject of growing regulatory scrutiny. By carefully evaluating and selecting components you can be assured that you are addressing the risk of particulate contamination.

5

Planning for Scale-Up

Ensuring that you are using components that will allow for scale-up to commercial manufacturing quantities is important. However, this often requires the unnecessary purchase of commercial quantities early in the development process leading to additional cost and waste of unused quantities.

Want to Learn More?

Proven vial containment that scales from R&D to Commercial

The West Ready Pack™ Containment Solution offers superior quality components to protect, store, and deliver your drug product.
Multiple options are available for stoppers, seals and vials to provide you with components best suited for your molecule.

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West Pharmaceutical Services Inc. is the exclusive distributor of Corning® Valor® Glass.