07.28.20 -- How NJIT Is Tackling CGT Development, Manufacturing

During the 12^th REMS (risk evaluation and mitigation strategies) Summit in Virginia, UBC’s Natalie O’Donnell, corporate vice president, safety, REMS, and strategic engagement, UBC, and Justin Wilson, director, software development and technology, UBC, presented a session on the impact that technology has had on REMS and the potential effect it can have in the future.

Maintaining the appropriate storage temperature of biological material is critical for downstream use. However, due to the complexity of this material and its sensitivity to temperature we are seeing an increase in nontraditional storage temperature requests. In this article we’ll explore some of the reasons why this is occurring and the associated challenges.

To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.

The traditional business model for in-house pharma manufacturing is nearly a thing of the past. More companies are turning to outsourcing to achieve flexibility and efficiency in a highly competitive market. 

Whether the experts come from a CRO or a regulatory consultancy, their help will be critical in helping develop the trial, meet with the Institutional Biosafety Committee, establish a timeline, and manage expectations. Here’s why.

A single vendor offers access to a network of experts who can share knowledge about a project as it moves from phase to phase, thus helping to navigate its path toward commercial success. 

Life sciences industries require highly controlled environments for drug research development and manufacturing.

A leader in the development of restorative cell therapies has a pipeline of products that may offer rapid-onset pain relief and restored function for orthopedic use. By implementing Skyland PIMS into their manufacturing plan, the drug developer is able to securely manage critical data in a collaborative, cloud-based, 21 CFR Part 11 compliant workspace.

With the current increase in development and investment, gene therapy companies will increasingly be looking to streamline the manufacture and commercialization of their therapies. Choosing a contract development manufacturing organization (CDMO) to ensure a smooth road to commercialization is essential. Contact us directly to learn more about picking the right strategic partner.

This podcast discusses the project execution, challenges, achievements, and success with a global pharmaceutical company whose goal was to scale up their manufacturing operations in the U.S. and Europe for an approved CAR-T product.

How high-density cell banking accelerates upstream processes by providing a larger volume of concentrated cells at the start of a production run, shortening seed training from weeks to days.