Ingress of carbon dioxide into bulk drug substance (BDS) containers that are stored and shipped on dry ice is a serious and often understated problem. Bottles are a container of choice for freezing ...

Figure 1: (a) Cell and gene therapy development pathway from patient/donor (red) to recipient (blue); (b) subcellular molecules and ions important for effective cell and gene therapy cultures ...

This webcast features: Aleš Štrancar, Managing Director, BIA Separations, a Sartorius Company In vitro transcription (IVT), the enzymatic process used for the production of mRNA vaccines, ...

Cell and gene therapies have reached clinical and commercial success as evidenced by the steady number of first approvals over the past four years. Drug developers face mounting challenges linked to ...

As gene therapies continue to stake their foothold on the clinical trial landscape and comprise the future wave of lifesaving pharmaceuticals, high-quality GMP-grade plasmids are increasingly in ...

Vaccines have been protecting against disease since the late 1700s. They function by triggering the immune system to generate short-term and long-term responses. Because there are many pathogens, ...

Mitochondria originated millions of years ago, likely when a eukaryotic cell incorporated a bacterium. Thus, mitochondrial DNA strands are 200,000× smaller than those from a cell’s nucleus. Depending ...

The steps involved in manufacturing pharmaceutical products require rigorous processes to ensure the safety of patients. One important such process is cleaning validation — a critical element in ...

Using multiple time-saving strategies in cell line development, discover how WuXi Biologics used lessons learned during the pandemic, to achieve a groundbreaking DNA to IND timeline applicable for non ...

Explore the latest news and expert commentary on Process Monitoring and Controls, brought to you by the editors of BioProcess International ...

Explore the latest news and expert commentary on CMC Forums, brought to you by the editors of BioProcess International ...

The bioprocess industry is undergoing a profound transformation, driven by the demand for greater efficiency, sustainability, and innovation. At the heart of this evolution is Process Intensification ...