Summer is here! That means you might hear the dreaded words, “Surprise! We are coming to audit you!” Whether it’s a client, supplier, or regulatory agency calling for an audit, those words can strike fear in even the most organized companies. But not if you're prepared by taking these five action items now.
- Targeting Von Willebrand Factor With An RNA Aptamer To Treat Stroke
- Will Point-Of-Care Manufacturing Unlock The Value Of Autologous Cell Therapies?
- The Business Case For Pharmaceutical Continuous Manufacturing
- Should My Biotech Startup Buy Or Produce The Proteins We Use?
- Where Oncology Drug Discovery Goes Next
- Plasmid DNA Manufacturing To See Impressive Growth In Years Ahead
- The 2 Factors Driving A Surge In Aptamer Use In Drug Discovery
EDITOR'S DESK
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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?
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.
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.
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?
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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
BIOPROCESSING WHITE PAPERS
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Integrated First-In-Human Services To Streamline End-To-End Development And Manufacturing
Lonza’s SimpliFiH®️ Solutions offering is designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.
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Turnkey Solutions To Improve Cell Culture Performance2/16/2022
This white paper describes the benefits of a one-step and neutral pH feed optimization strategy, as well as the potential application of chemically defined hydrolysates.
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Improve Your Molecular Cloning Process With Synthetic Biology Automation5/25/2023
Explore the promising field of synthetic biology, the hurtles manufacturers face with it's workflow, and how automation can help accelerating throughput and walkaway time.
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The Roles Of Operational Readiness, Capital Projects In Drug Manufacturing8/31/2022
Read more about what a facility needs to achieve operational readiness and the necessary steps to take to be at full scale production when the “go” button is hit.
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Continuing The Conversation: The Future Of Reimbursement For Cell And Gene Therapies8/26/2021
Cell and gene therapies were expected to pose significant payer challenges however, several high-cost cell and gene therapies have achieved rapid and broad reimbursement to date across major payer bodies.
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Systems For Shop Floor Automation And Digitization9/30/2022
We review an automation system that is based on a standard technology platform, with standardized hardware, networking, and software elements and is designed to securely connect to end-user networks.
BIOPROCESSING APP NOTES & CASE STUDIES
- Vero Cell-Based Vaccine Production: Cell lines, Media And Bioreactor Options
- How to Select the Right Integrity Test Instrument
- Using Dual Dye Ratiometric Technology To Quantify The Impact Of Pipette Tip Type
- Buffer Management Simplified: Fluid Management Systems Keep You Moving
- Contract Testing Lab Quickly Responds To Increased Customer Requests For Nitrosamine Services
BIOPROCESS ONLINE CONTENT COLLECTIONS

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.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Meeting GMP Requirements For Allogeneic Cell Therapies
- The Route To Faster Microbial Quality Control
- Establishing Analytical Methods For Emerging mRNA-Based Therapies
- Healthy Cells, Healthy Results: How To Improve Cell Line Development
- A Single-Use, Scale-Down, Predictive Solution For Intensified Perfusion Development
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 06.08.23 -- Discover The New Possibilities For Increased Dosing Capabilities Offered By Nanoformed APIs
- 06.08.23 -- Ensure Protein Stability Through Biophysical Characterization
- 06.07.23 -- Computational Biology's Role in Gene Therapy, Building Flagship Pioneering, and more episodes to check out!
- 06.07.23 -- Not All Plate Counting Technologies Are The Same
- 06.06.23 -- Leverage An Integrated Drug Substance And Drug Product CMC Strategy