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Competition in the biopharmaceutical pipeline is ever-increasing. Established companies are utilizing accelerated development pathways for drug approval, and there is a growing number of new entrants in the market. As a result, the race to gain approval and commercialize new drugs is becoming increasingly faster.
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.
You need guidance early in your development so you can avoid mistakes that could cost you extra time and money later in the process.
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
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?
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.
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.
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.
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.
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.
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.
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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