EDITOR'S DESK

  • Anatomy Of A Biopharma VC Deal

    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?

Topical Biologics In Ophthalmology?

A recent clinical study of an eyedrop formulated with Grifols’ Immunoglobulin-based Flebogamma DIF offers cause for optimism among multiple stakeholders. It could become the first-approved topically administered biologic therapy for dry eye disease. 

AAV Manufacturing Field: An Interactive Look

Mapping the adeno-associated virus (AAV) therapeutic space gives us a glimpse into indication priorities for gene therapy, and a look at whose got their fingers in which partners’ pots. Check out this interactive graphic from DeciBio Principal Carl Schoellhammer, Ph.D. It's not only instructive, its kind of therapeutic to play with. 

Cashing In On Biopharma Collaboration

How does a biopharma business that’s potentially years away from its first shot at therapeutic sales revenue thrive in a high-inflation, high-interest, supply-constrained business environment?

What’s In A “Biopharma” Name?

As exciting new modalities, hybrids, and conjugates blur therapeutic lines, let’s not forget what “bio” means, how biologic therapeutics are distinguished, and why they were delineated as such in the first place. Make sure you're not a BINO (Bio In Name Only) when you’re naming your “biotech.”

GUEST COLUMNISTS

  • Targeting Von Willebrand Factor With An RNA Aptamer To Treat Stroke

    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.

  • Will Point-Of-Care Manufacturing Unlock The Value Of Autologous Cell Therapies?

    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.

  • 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.

  • 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.

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BIOPROCESS ONLINE CONTENT COLLECTIONS

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Biopharmaceutical supply chain strategies can be profoundly bespoke, but best practices like redundancy and quality risk management offer a starting point. The ideas in this collection of recent articles from Bioprocess Online can help shore up your own network in defense of the next upset.

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