The West Blog

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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.

Erik Anderson

October 21, 2021

Latest Blogs

By Your Side

Marisa Leuzzi

October 13, 2021

Latest Blogs

FluroTec COVID-19 Vaccines

Page McAndrew PhD

September 16, 2021

Latest Blogs

Germany Floods Philanthropy Our Culture Of Giving

In July, the western states of Rhineland-Palatinate and North Rhine-Westphalia in Germany experienced devastating floods caused by days of extreme rainfall. Our Eschweiler and Stolberg production sites and Kiefernweg Campus were not directly impacted; however, the communities were heavily affected. While we are thankful that none of our team members were injured, we empathize with many of them who are dealing with damage to their homes and personal property, as well as trauma caused by such a devastating event.

Gillian Power

September 14, 2021

Latest Blogs

Quality Enhancements Flurotec® Barrier Film

One of the challenges of sharing technical content is making the material engaging and easily digestible to many different types of learners. It must not only be scientifically accurate, but also needs to capture and keep the attention of the intended audience. The Knowledge Center on West’s website is a valuable repository of written and presented materials, created by the experts who develop and test our products. It is also now home to the Learning Center, a section of the Knowledge Center that shares information on a more introductory level, aimed at new employees or companies that are new to packaging. In an effort to continue enhancing our website content, we are now also starting to add new types of media. In the age of podcasts and vlogs (video blogs), we understand that video and audio are just as helpful (maybe more so!) for people trying to grasp a new concept.

Tara Haarlander

September 10, 2021

Previous Blogs

Container Closure Integrity Cell and Gene Therapy Integrated Solutions Platform

Container Closure Integrity Evaluation for Cell and Gene Therapies

By Olga Laskina, PhD.

December 23, 2020

With the growth of gene and cell therapies, there is an increased need to characterize container closure systems (CCS) at the low temperatures experienced during their lifecycles: ultra-low (-80°C) for genes and cryogenic (-180°C) for cells. West’s Integrated Solutions platform includes the state-of-the-art container closure integrity (CCI) capabilities needed for these therapies.

Cell and Gene Therapy Storage and Shipment Packaging Primary Packaging

Storage/Shipment of Gene Therapies – Primary Package Systems

By Page McAndrew, PhD

September 04, 2020

Gene therapies are stored and shipped at ultra-low temperature (approximately -80^oC, either in a refrigerator or on dry ice). This provides a challenge to the primary package systems in maintaining container closure integrity (CCI), especially systems comprising glass vials and elastomer stoppers. These materials have different coefficients of thermal expansion. Upon cooling from room temperature to ultra-low temperature, they contract at different rates; this may lead to gaps and CCI loss.

Cell and Gene Therapy

Packaging Containment Solutions for Cell and Gene Therapies

By Abigail Hisler

July 27, 2020

Research in the area of cell and gene therapies started almost 40 years ago, however recently there has been a surge of activity including landmark regulatory approvals for therapies treating chronic and rare diseases. In 2017 and 2018 the FDA approved the first two CART-T cell therapies for cancer treatment and the first two gene therapies for rare diseases. All four of these cell and gene therapies were approved under the FDA Accelerated Approval Program, aimed at expediting approvals for life saving drug therapies. These regulatory programs have the potential to shorten drug development as much as 1-3 years. Currently, there are more than 1,000 regenerative medicine clinical trials underway globally¹, and the market is expected to grow rapidly over the next 10+ years.