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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.

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FDA Releases Draft Guidance To Accelerate Biosimilar Development
New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.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

Real-World Phase-Appropriate Control Lessons For mAb/ADC Manufacturers
Effective mAb and ADC manufacturing control strategies evolve through the phases. These four principles should guide your strategy design as goals shift.
High Specific Productivity For Leaner Sustainable Bioprocessing
Improving specific productivity moves the goal beyond pumping out higher titers, but it demands a deeper understanding of cellular biology and protein expression.
New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.
Facility Considerations When Retrofitting Legacy Sites For ADCs
Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.
In Vivo's Biggest Threat — Comparison To Old Models
In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.
Managing Supply Chain Risk In Scale-Up And Multisite Trials
Scaling trials across sites can lock in supply risk early. Learn how biologic variability, long lead times, and multisite complexity threaten trials and how to spot warning signs fast.
The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.
Why Use Total Organic Carbon Analysis For Cleaning Validation?
Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.

BIOPROCESSING WHITE PAPERS

Leveraging Digitalization To Resolve CGT Manufacturing Challenges
Uncover digitalization's role in overcoming manufacturing challenges in cell and gene therapies to enhance efficiency, quality, and scalability through data analytics and real-time monitoring.

Smart Scaling For Cell And Gene Therapies
2/5/2026

To meet patient demand, advanced therapy manufacturing processes must be commercial ready. CGT sponsors can mitigate risk and protect viability by partnering with a CDMO that prioritizes scalability.
The Complete Guide To Immunohistochemistry
9/24/2024

Immunohistochemistry (IHC) is a tool for visualizing the distribution and localization of antigens within tissue sections. Learn about IHC sample preparation, detection and amplification systems, and more.
Innovation And Evolution Of Affinity Chromatography Resins For Monoclonal Antibody Purification
9/30/2025

Discover how innovations in ligand design and resin manufacturing have improved monoclonal antibody purification by enhancing selectivity, stability, and process economics.
Single-Use Technology And Environmental Responsibility In Biopharmaceuticals
3/27/2025

Learn about strategies such as regional manufacturing and advanced single-use systems and their potential to minimize carbon footprint and enhance sustainable biomanufacturing.
Improving Gene Therapy Development With Organ-On-A-Chip Technology
8/7/2024

Explore the current challenges of developing gene therapies, the potential of Organ-on-a-Chip technology, the future of gene therapy, and more.

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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.