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Competition in the biopharmaceutical pipeline is ever increasing. The growing number of entrants into the market and established companies utilizing accelerated development pathways are making the race to approval and commercialization even 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. If you need guidance early in your development so you can avoid mistakes that could cost you extra time and money later in the process, West can help. We can partner with you to help get your drug to market faster without compromise.
Challenges in Drug Development
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. Understanding the importance and implications of packaging decisions early in your process can reduce risk to your program and prevent delays to market.
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 guidances to avoid compliance challenges?
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.
Learn More
If you work for a startup biotech or emerging company and are in the process of developing a drug, download our white paper and/or e-book to learn about containment solutions to mitigate your risks and help you get your drug to the patient faster.
Whitepaper
Five Key Considerations for Component Selection
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.
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.
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. This is often done with the use of barrier coatings, such as FluroTec™ film, a globally used coating in at least 130 approved products that can prevent chemical migration from the elastomer to the drug product.
Minimizing Particulate Risk
Subvisible particulate continues to be a significant patient safety concern and is the subject of growing regulatory scrutiny. Careful evaluation and selection of components can ensure you are addressing the risk of particulate contamination. Watch our webinar Understanding & Applying the updated FDA Guidance: Inspection of Injectable Products for Visible Particulate (link) for an overview of the draft FDA guidance on the inspection of injectable products for visible particulates and discussion on how to apply the recommendations.
Planning for Scale Up
Ensuring that you are using components what 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.
Learn More
The following resources can help you understand how component selection can impact your budget and speed to market.
Featured Blogs
December 04, 2020
How to get your biologic approved quickly when you don’t have the resources of big pharma
Biologics is a rapidly growing market, with a robust R&D pipeline bringing innovative therapies to treat patients. Today, there are 4,000 more active biologic programs in the pipeline compared to 2015, with biologics development programs growing 2.5 times faster than small molecules. New entrants into the biologics market are driving this rapid growth. As of 2018, emerging companies represented 84% of all early phase research.1 Not only is this segment driving R&D growth, but they are having commercial success in bringing their drugs to market. In 2018, 65% of new drugs launched were patented by emerging companies.1
October 21, 2021
Overcoming the Challenges of Fill-Finish Manufacturing when Selecting Novel Containment Solutions
The need for advanced containment solutions, and novel fill-finish processing to enable implementation of these solutions, continues to grow as more complex drug products enter multiple pipelines. As biotech companies develop these complex drug products, the integration of product and process knowledge is crucial to delivering product safety, quality, identity, potency, and purity. And as biotech companies seek partners to help accelerate their development processes, West is committed to leading multi-disciplined, high-performance teams in developing optimal fill-finish solutions for novel packaging and container systems. This dynamic partnership is well-illustrated by the following case study.
March 03, 2022
CCI at Ultra-Low Temperatures: Don’t be Left Out in the Cold
The FDA has approved over twenty (20) cell and gene therapy drugs, and with the rapid growth of the cell and gene therapy market, there is greater demand than ever to demonstrate container-closure integrity (CCI) at ultra-low temperatures. To preserve the product’s efficacy, most cell and gene therapy drugs are stored at temperatures below -60ºC. Many of these products are packaged in either vial systems or cryogenic freezing bags. While each of these container-closure systems poses a unique challenge for the evaluation of CCI at ultra-low temperatures, the discussion in this blog focuses specifically on vial systems.
December 04, 2020
How to get your biologic approved quickly when you don’t have the resources of big pharma
Biologics is a rapidly growing market, with a robust R&D pipeline bringing innovative therapies to treat patients. Today, there are 4,000 more active biologic programs in the pipeline compared to 2015, with biologics development programs growing 2.5 times faster than small molecules. New entrants into the biologics market are driving this rapid growth. As of 2018, emerging companies represented 84% of all early phase research.1 Not only is this segment driving R&D growth, but they are having commercial success in bringing their drugs to market. In 2018, 65% of new drugs launched were patented by emerging companies.1
October 21, 2021
Overcoming the Challenges of Fill-Finish Manufacturing when Selecting Novel Containment Solutions
The need for advanced containment solutions, and novel fill-finish processing to enable implementation of these solutions, continues to grow as more complex drug products enter multiple pipelines. As biotech companies develop these complex drug products, the integration of product and process knowledge is crucial to delivering product safety, quality, identity, potency, and purity. And as biotech companies seek partners to help accelerate their development processes, West is committed to leading multi-disciplined, high-performance teams in developing optimal fill-finish solutions for novel packaging and container systems. This dynamic partnership is well-illustrated by the following case study.
March 03, 2022
CCI at Ultra-Low Temperatures: Don’t be Left Out in the Cold
The FDA has approved over twenty (20) cell and gene therapy drugs, and with the rapid growth of the cell and gene therapy market, there is greater demand than ever to demonstrate container-closure integrity (CCI) at ultra-low temperatures. To preserve the product’s efficacy, most cell and gene therapy drugs are stored at temperatures below -60ºC. Many of these products are packaged in either vial systems or cryogenic freezing bags. While each of these container-closure systems poses a unique challenge for the evaluation of CCI at ultra-low temperatures, the discussion in this blog focuses specifically on vial systems.
West and the diamond logo, Ready Pack and logo, FluroTec, Flip-Off, and NovaPure are trademarks or registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
Corning and Valor are registered trademarks of Corning Incorporated.
Crystal Zenith and D Sigma are trademarks of Daikyo Seiko, Ltd.
adaptiQ is a trademark of SCHOTT AG.
West Pharmaceutical Services Inc. is the exclusive distributor of Corning® Valor® Glass.
FluroTec and Crystal Zenith technologies are licensed from Daikyo Seiko, Ltd.