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?

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.

An important step in the gene therapy development process is assembling biodistribution data in suitable animals in relation to the intended clinical population. Developing an accurate biodistribution profile is influenced by factors such as the route of administration, dose level(s), dosing regimen, and the animal immune response to the gene therapy product. The FDA adopted this ICH guidance in May 2023, and the EMA plans to adopt it in September 2023.

One aspect of the complex cell and gene therapy manufacturing process is often neglected or underestimated: the sources and quality of the materials used. Employ this article's best practices and strategies for ensuring supply continuity and the phase-appropriate qualification of materials.

In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.

In their second article of this two-part series, the authors detail how to make the partnership between the cell and gene therapy company and CDMO mutually successful.

When terminal sterilization is not an option, primary packaging materials have a fundamental role in preventing contamination. This article describes how packaging, including containers and closure systems, helps maintain sterility in aseptic manufacturing.

Drug/therapy development has made significant leaps in innovation in recent years, but common issues that hinder progress still exist. Are you harnessing and optimizing your data for speedier drug development and quicker launch timescales? This article shares important recommendations.