Why does a venture capitalist choose to fund a biopharma company? What prompts them to choose not to? And why should (or shouldn't) a biopharma company take a VC's money?

Developing new treatments for acute ischemic stroke that can quickly and safely intervene at the right place and time has been a challenging endeavor. Today, the situation is changing due to technological developments related to stroke and recent advances in RNA-based medicines.

To shorten the treatment journey for autologous cell therapy patients, a promising model that appears to be emerging is point-of-care (PoC) manufacturing in major cancer and academic medical centers and hospital networks. PoC compresses the vein-to-vein process, brings production closer to the patient, and has the potential to address other ongoing concerns, such as reduction of risks and costs.

Using continuous manufacturing technologies is a risk and often a barrier to implementing it. In this first article of a two-part series, the author provides a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with specific considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers.

"Should we build out an internal group of scientific expertise or delegate work to external vendors?," is a question that this author has faced in his career. He shares key considerations building protein science teams.

Plasmid DNA is surging as an ideal starting material for gene therapies and vaccine production. Using new market research, let’s look at key market drivers, vital roadblocks, regional analysis, and the leading players in the space.

Aptamers offer advantages over antibodies, including lower immunogenicity and toxicity, better tissue penetration, lower production costs, and a very long shelf life. Why, then, have we not seen more of these come to market? Two hurdles have stood in the way until recently.

Industry-accepted reference materials give drug manufacturers a competitive edge. Data shows that first-in-class mAbs hold a market lead over later entrants. This article discusses the benefits of using well-characterized reference materials instead of spending time and resources to develop them from scratch. 

During my career as an executive in pharmaceutical manufacturing quality assurance, I have heard the term “cost of quality” (COQ) over and over when advocating for budget and resources. Most people think that it is just an excuse for higher costs, but that is not true. I'll share what is involved in calculating the COQ and why it's important.