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.
- Real-World Phase-Appropriate Control Lessons For mAb/ADC Manufacturers
- High Specific Productivity For Leaner Sustainable Bioprocessing
- New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
- Taking The First Steps Towards Digitalizing Biopharma Development
- Facility Considerations When Retrofitting Legacy Sites For ADCs
- In Vivo's Biggest Threat — Comparison To Old Models
- Managing Supply Chain Risk In Scale-Up And Multisite Trials
EDITOR'S DESK
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FDA Releases Draft Guidance To Accelerate Biosimilar Development
New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.
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."
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.
At BioProcess International 2025, leaders from AbbVie and Amgen gave keynote presentations about how their companies are advancing product development through digital tools.
AI consultant Kat Kozyrytska advocates for ethical AI adoption and explains its potential to foster collaboration across the industry.
GUEST COLUMNISTS
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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Methods For Determining Equipment Capability Of Freeze-Dryers
Observe two experimental methods for determining choked flow: the minimum controllable pressure method and the choke point method.
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Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility10/16/2024
The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.
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Why Choose Robotic Processing For Small Batch Aseptic Filling1/9/2026
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.
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Guide To Seeding, Expanding, And Harvesting Stem Cells6/18/2025
Investigate important considerations for working with three different stem cell types: mesenchymal stem/stromal cells, induced pluripotent stem cells, and neural stem cells.
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Incremental Adoption Of A Modular Operations Platform1/31/2025
Discover the potential of a modular operations platform that scales the benefits of digitalization and aids organizations in implementing a unified data strategy to realize the full potential of smart manufacturing.
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The Complete Flow Cytometry Guide9/24/2024
This guide covers the fundamentals of flow cytometry, aiming to help you better understand how it works, when it is most valuable, and how to conduct an experiment.
BIOPROCESSING APP NOTES & CASE STUDIES
- Taking The First Steps Towards Digitalizing Biopharma Development
- Bioprocess Online's 2025 Editorial Reflections
- FDA Releases Draft Guidance To Accelerate Biosimilar Development
- Supporting The Next Generation Of ADCs
- AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing
- On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration
- On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing
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.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Flexibility Or Scale? Navigating The Single Use Vs. Stainless Steel Debate
- Selecting A Prefillable Syringe System With Confidence
- Designing Drug Substance Processes For Fill-Finish Compatibility
- Accelerating Antibody Screening With A Scalable Protein Expression Platform
- Viral Clearance Strategies For Monoclonal Antibodies And Proteins
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 02.12.26 -- Optimizing Cell Line Development With Emerging Technologies
- 02.12.26 -- Taking The First Steps Towards Digitalizing Biopharma Development
- 02.11.26 -- Sharpen Your Chromatography Performance
- 02.11.26 -- Do's And Don'ts Of Material Handling When Retrofitting For ADCs
- 02.10.26 -- Transform Your Bioprocessing Workflow With Scalable, Automated, And Single‑Use Technologies