BIO From The Editor and Guest Columns
The Business Case For Pharmaceutical Continuous Manufacturing
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 My Biotech Startup Buy Or Produce The Proteins We Use?
"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.
Where Oncology Drug Discovery Goes Next
AbbVie Bay Area Site Head and VP of Oncology Discovery Research Steve Davidsen, Ph.D. lays out the primary challenges to pushing forward in areas of high, unmet oncological need: accelerating discovery to shorten the time to patient impact and identifying optimal patients for a given mechanism of action or molecule.
Plasmid DNA Manufacturing To See Impressive Growth In Years Ahead
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.
The 2 Factors Driving A Surge In Aptamer Use In Drug Discovery
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.
Here's How USP mAb Standards Support Fast-Evolving Platform Approaches
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.
Cost Of Quality: Worth Every Cent In Bio/Pharmaceutical Manufacturing
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.
FDA Adopts ICH Guidance On Assessing Nonclinical Biodistribution Of Gene Therapy Viral Vectors
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.
Best Practices For Raw Material And Supplier Management For Cell & Gene Therapy Manufacturing
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.
All You Need To Know About Contamination Control Strategies, Part 2
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.