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Where Does 3D-Printed Single-Use Tech Fit In The Development Pipeline?

Additive manufacturing in early-phase process development is growing more common, but the practice comes with important considerations.

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EDITOR'S DESK

On The Ground At NextGen Biomed 2026
Bioprocess Online caught up with Tiffany D. Rau, Ph.D., CMC consultant and adjunct professor of biochemistry and cell biology at the University College Cork in Ireland, at Oxford Global's 2026 NextGen Biomed conference.

Integrate Upstream/Downstream To Reduce Development Risks And Costs

Coordinating unit operations can help reduce costs and mitigate challenges in process development. Check out these key takeaways from the Bioprocess Online Live event “Optimizing Process Development Through Upstream and Downstream Integration.”

What If The U.S. Government Stopped Funding Biotech?

It sets off a real tension – ideological, economic, even personal. But what would happen if the U.S. government cut direct financial support for “biotechnology research,” leaving it entirely to investors, private and public markets, and bigger pharma? "Our industry’s mind-meld says with no government largesse our biotech industry collapses," writes Chief Editor Louis Garguilo. It's an "outlandish hypothetical," but he asks for a few minutes to go through this. And he has help in making his case.

Advising The Biotech C-Suite To Reconsider Quality

“I assist C-suite executives to transfer quality from a painful cost center to a competitive asset." It's the type of bold statement that draws one's attention. Chief Editor Louis Garguilo asked David Grote on what his assertion means materially – and how that’s applied to working with CDMOs. Here's their discussion that focuses on a transformation that moves executives from regarding quality as ‘overhead’ to recognizing quality as “an operational element for business advantage.”

A Biotech Business Model That's Investor-Friendly

For biotechs meeting with current and potential investors, says Edward Ahn, CEO, Medipost Inc., “it should be about demonstrating your business continuity more than anything else.” Investors know, he says, “any supply chain may be fragile.” Indeed, Ahn’s organization has put in place an intriguing business model to address such concerns. It includes owning part of a CDMO.

GUEST COLUMNISTS

Inside AstraZeneca's Fully Electrified Cell Therapy Facility
The company won an ISPE FOYA for its Rockville, Maryland, manufacturing site that boasts 100% uptime and flexible capacity to produce thousands of batches annually.
Affinity Membranes Are Moving Closer To Commercial Reality
A recent review shows advances in surface chemistry and ligand engineering are moving the needle for next-generation affinity membranes.
Mastering Temperature Control And Advanced Therapy Logistics In Global Clinical Supply Chains
Cold chain failures can derail patient dosing in global trials. Real-time visibility and predictive logistics are becoming mission critical.
AI Has Arrived In Biotech CMC Amid Patchwork Governance
AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.
Avoiding Common Pitfalls In CDMO–Sponsor Relationships Through Integrated Execution Models
Let's delve into the key pitfalls to avoid when working with a CDMO and the integrated execution model that solves or mitigates these pitfalls before they occur.
The Future Of Continuous Is Integrated Manufacturing: The 4 Misconceptions About A Lean Process
Pharmaceutical continuous manufacturing is an enabler of better manufacturing, but only when implemented with intention.
CDMO Selection: Start With The Relationship, Not The RFP
Friction often comes from unspoken expectations. Before production begins, treat the combined sponsor-CDMO group as one extended team and intentionally make “how we work together” visible.
Why FAT Should Confirm Alignment, Not Reveal Its Absence
In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset.

BIOPROCESSING WHITE PAPERS

Why Pharmaceutical Scientists Trust The Discovery Core Rheometer
Drug formulations demand more than single‑point viscosity data. Explore how rheology reveals stability, flow, and structural behavior across suspensions, topicals, and injectables.

Advancing Cell Culture Strategies To Accelerate Biologics Development
5/5/2026

Integrated stable expression strategies accelerate biologics material generation, improving scalability, consistency, and early developability insights while reducing bottlenecks, variability, and risks in transitioning from discovery to manufacturing.
A Shift Towards Biofluorescent Particle Counters In Manufacturing
5/12/2025

Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
The Impact Of Artificial Intelligence On CQV
7/23/2025

AI is revolutionizing CQV in life sciences by automating documentation, enabling real-time monitoring, and driving predictive quality to boost efficiency and compliance across validation processes.
Innovation In Filtration
3/18/2025

Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.
How Automation Is Driving Carbon Reduction
10/21/2025

Manufacturers can cut emissions and boost efficiency by modernizing energy and utility systems. Explore how smart automation and analytics offer fast ROI and long-term sustainability.

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BIOPROCESSING APP NOTES & CASE STUDIES

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BIOPROCESS ONLINE CONTENT COLLECTIONS

This collection of articles digs into the industry’s growing focus on knowledge management as an indispensable facet of biomanufacturing and pharmaceutical development, exploring how it plays into risk management, quality, vendor relationships, and supply chain resilience.