• 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.”


  • 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.

  • Part 2: What You Should Expect from A High-Functioning CDMO

    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.

  • Let’s Explore Packaging For Aseptic Manufacturing

    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.

  • Optimizing Digitalization To Accelerate Your R&D

    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.





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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