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MES Is Still In The CD ROM Era But The Data Architecture Has Moved On

Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.

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EDITOR'S DESK

FDA Releases Draft Guidance To Accelerate Biosimilar Development
New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.

Supporting The Next Generation Of ADCs

Experts discuss innovation in antibody-drug conjugate (ADC) technology and how these impact CMC strategy. This summary captures key takeaways from the Bioprocess Online Live event "Evolving CMC Strategies To Enable Next-Gen ADCs."

The 9 Fastest-Growing Outsourcing Segments

Capacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.

AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing

At BioProcess International 2025, leaders from AbbVie and Amgen gave keynote presentations about how their companies are advancing product development through digital tools.

On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration

AI consultant Kat Kozyrytska advocates for ethical AI adoption and explains its potential to foster collaboration across the industry.

GUEST COLUMNISTS

Using Carbon Nanotubes To Pinpoint Optimal Harvest Time in Bioprocessing
Cell-free expression systems confound the moment of peak expression. These nanosensors signal through crude lysate for process optimization and endpoint monitoring.
U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.
A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset
Fill/finish operations are famously resource-heavy. Nonetheless, Novo set out to achieve ambitious environmental goals with its $4.1 billion project in North Carolina.
Thoughtful Supply Strategy Is No Longer Optional In Drug Development
In drug discovery and development, supply chain decisions are often treated as a downstream concern. In reality, supply strategy is a development decision from the very beginning.
Active Versus Passive Shipping Solutions For Clinical Shipments
Explore active and passive temperature-controlled shipping solutions and their impact on clinical trial supply, balancing cost, risk, and product integrity.
The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality
The Trump administration has effectively merged national security, trade policy, and drug quality. Now, foreign manufacturers lacking deals face paying a "quality tax."
January 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
This Industrial Fungus Has Protein Expression Promise For Pharma
Trichoderma reesei is well characterized for industrial uses. A Finnish research group is exploring it for pharmaceutical protein expression.

BIOPROCESSING WHITE PAPERS

Epigenetics Application Guide
To fully understand biology and disease mechanisms, it is crucial to explore the role of epigenetic factors. Explore how epigenetic regulation works and methods to study these essential components.

Engineering Reliability In Cell Therapy Manufacturing
2/3/2026

A cell therapy manufacturing model built on precision planning, digital execution, lifecycle‑ready CMC systems, and transparent collaboration to achieve high reliability and reduce variability across programs.
Digital Innovation And Sustainability Are Redefining Biomanufacturing
12/8/2025

Next Generation Manufacturing (NGM) integrates advanced process design, digital innovation, and strategic facility planning to facilitate agile, efficient, and sustainable biopharmaceutical production.
Optimizing AAV Purification for High Recovery
2/27/2024

How can you improve purification methods for your AAVs and enhance the efficacy and safety of your gene therapy treatments?
Why Choose Robotic Processing For Small Batch Aseptic Filling
1/9/2026

Reducing human intervention in aseptic filling is critical for safety and cost efficiency. Learn why automation is essential for small-batch applications and how it’s transforming sterile drug manufacturing.
ICH Q12 Implementation: Regulatory Intelligence And PACM Agility
7/9/2024

Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.

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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.