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A Novel In Vitro Glycosylation Approach For Difficult PTMs

Post-translational modifications of membrane proteins have been historically challenging. Research shows how an in vitro approach brings stability and predictability.

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FDA Releases Draft Guidance To Accelerate Biosimilar Development
New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.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

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.
Leveraging Conventional Therapeutics Skills For Cell And Gene Therapy
Cell and gene therapies share fundamental objectives with conventional biologics. Their common challenges offer a natural starting point to solving downstream bottlenecks.

BIOPROCESSING WHITE PAPERS

Building A Legacy In Sterile Injectables Through Strong CMO Synergy
Examine how a CMO can deliver significant value to drug developers by fostering successful outsourcing relationships, streamlining the path to market, and supporting demands.

A Comparative Analysis Between Liquid Nitrogen And Mechanical Freezers
9/23/2025

Explore the differences between liquid nitrogen and mechanical cryogenic freezers, and learn how each method supports scientific, medical, and industrial storage needs.
Connecting Quality Management, Patient-Centricity, And Business Value
2/18/2025

Examine why organizations must integrate data and processes to enhance quality and insights to improve operational efficiency, patient health, and regulatory compliance.
Quality By Design In The Pharmaceutical Industry
12/12/2025

Real-time release and digital quality management, powered by PAT, are driving efficiency and compliance, reshaping how manufacturers achieve speed, consistency, and competitive advantage.
Leak Rate Testing for Freeze Dryers: A Scientific Approach
10/16/2024

Explore our innovative approach to establishing leak rate acceptance criteria and ensure the integrity of your freeze-drying processes for sterile pharmaceutical production.
Understanding Potency In Gene Therapy Development
2/28/2024

Explore the importance of understanding potency in cell and gene therapy (CGT) development and the challenges in developing potency assays for CGT products.

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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.