- Why Use Total Organic Carbon Analysis For Cleaning Validation?
- December 2025 — CDMO Opportunities And Threats Report
- Do's And Don'ts Of Material Handling When Retrofitting For ADCs
- Building Enterprise Resilience From QRM Signals
- Single-Use Standards Are Maturing, But The Process Remains King
- Mind The Potent Compounds When Retrofitting Facilities For ADCs
- New USP Research Shows MAM As Alternative To Conventional Methods
EDITOR'S DESK
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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."
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.
Takeda head of process development, Amy Shaw, explains what factors to consider when scaling up or scaling out cell therapy manufacturing.
GUEST COLUMNISTS
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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.
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December 2025 — 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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Do's And Don'ts Of Material Handling When Retrofitting For ADCs
Antibody-drug conjugate manufacturing includes extremely dangerous ingredients, and most legacy facilities lack the features and flows for safe handling.
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Building Enterprise Resilience From QRM Signals
Turn enterprise resource management (ERM) from a checklist into a true decision system — so risk informs everyday choices before quality events become supply disruptions, delays, or regulatory exposure.
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Single-Use Standards Are Maturing, But The Process Remains King
The food industry inspired single-use in biopharma, but the regulatory landscape is far more complex. If you're worried about compliance, this discussion can help.
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Mind The Potent Compounds When Retrofitting Facilities For ADCs
Antibody-drug conjugate manufacturing introduces significantly more risk to employees. Likewise, facility safety requirements are especially intense.
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New USP Research Shows MAM As Alternative To Conventional Methods
Results show the multi-attribute method provided superior specificity and detected molecular modifications far better than the status quo.
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Deploying A Vendor Life Cycle Oversight Model
A practical guide for adding oversight, based on a hierarchy of metrics, to quality agreements to transform them into living, metrics-driven control instruments.
BIOPROCESSING WHITE PAPERS
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Isolate Bright GFP-Expressing HEK293 Cells For Cell Line Development Workflow
Explore a high-efficiency workflow for isolating and expanding GFP-expressing HEK293 cells that enables stable, bright clones ideal for imaging and tracking to simplify clonal development.
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Enabling CDMOs To Focus On Core Priorities4/26/2024
Explore innovative solutions for CDMO's striving to remain competitive as the biopharmaceutical market grows and evolves.
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Finding An Optimal Harvest Solution By Considering Cost And Sustainability7/10/2024
Choosing the right harvest solution is pivotal in the pursuit of efficient and sustainable bioproduction. Explore the benefits of a single-use centrifuge over traditional depth filtration methods.
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Combining Digital Platforms And QbD Principles7/9/2024
How can data and digitalization further improve pharmaceutical development and the continuous, quick, and efficient delivery of products?
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Digital Transformation And Quality By Design For Enhanced Development7/23/2025
Discover how digital transformation and Quality by Design are revolutionizing pharmaceutical development to boost efficiency, enhance compliance, and accelerate innovation across the drug lifecycle.
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Improving Gene Therapy Development With Organ-On-A-Chip Technology8/7/2024
Explore the current challenges of developing gene therapies, the potential of Organ-on-a-Chip technology, the future of gene therapy, and more.
BIOPROCESSING APP NOTES & CASE STUDIES
- 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
- On The Ground At BPI: Industry Reflections With Carl Schoellhammer, Ph.D.
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
- Next-Level Cell Lines: An Integrated Approach To Biologic Innovation
- Turbocharging pDNA Production: CDMO Case Study In Optimization
- Beyond Geographies — Derisking Global Manufacturing
- Sterile Filling Readiness In The Drug Device Delivery Ecosystem
- Collaborate For Standardization In Large-Volume Subcutaneous Delivery
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 01.26.26 -- A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches
- 01.23.26 -- STREAM Edition: How To Strategically Integrate New Technology Into Existing Workflows
- 01.23.26 -- Data Governance And Regulations For AI Use In GMP With Peter Baker
- 01.22.26 -- Metrics, Not Audits, Should Lead Vendor Accountability
- 01.21.26 -- Avoiding Protein Purification Artifacts That Still Undermine Drug Design