10.31.22 -- Assessing mRNA Vaccine Quality

Downstream processing for biologic drugs often requires the use of harsh chemicals that can damage SUT components. CPC designers identified a polymer to handle rough downstream chemicals.

The promise of bispecific antibodies (bsAbs) stems from their off-the-shelf nature and ability to bind to two or more different targets or epitopes, thereby performing multiple functions.

Discover the three major challenges cell and gene therapy manufacturers are facing today and experienced insights on how to overcome them.

As you create your hot-melt extrusion (HME) strategy to manufacture amorphous solid dispersions (ASDs), there are several considerations to ensure your plan is flexible, robust, and comprehensive.

Oral solid dose experts Amy Trotch and Kieran Coffey offer insight into OSD coating techniques and technologies and how to effectively scale and transfer them for commercial manufacturing. 

Whether you are scaling up, moving to another facility, or moving to another outsourcing partner, it’s vital to create a robust strategy that enables you to move with speed while managing costs.

Read how, by enabling the delivery of solutions in specific areas, the new era of manufacturing can begin, and the next generation of cell-based immunotherapies can reach patients.

Without proper handling and packaging, the efficacy of probiotics can be compromised at any point of the packaging, storage, and transportation process, impacting shelf life and effectiveness.

Realizing the potential of next-generation molecules calls on appropriate expression technologies and development processes that can facilitate their path to market.

This paper discusses the regulatory expectations for the incorporation of alternative methods with a focus on comparability and strategies for easier substitution of current methods.

Cost efficiencies and expertise again go hand in hand, with companies often outsourcing or partnering primarily to gain access to manufacturing know-how.

Improve the characterization of cell-based AAV transfection and production, increase the efficiency and accuracy of both processes, and shorten development time.

Iwan Bertholjotti, director of commercial bioconjugate development, and Dr. Bernhard Stump, head of bioconjugate development, discuss complexity and uncertainty in the bioconjugates market.

Late-phase development requires a holistic development strategy driven by a well-defined target product profile. Here's an overview of the complex path to a successful product launch.