- New USP Research Shows MAM As Alternative To Conventional Methods
- Deploying A Vendor Life Cycle Oversight Model
- Moving Leukopaks From GTP To GMP Is One Cell Therapy Trend To Watch In '26
- Metrics, Not Audits, Should Lead Vendor Accountability
- Ask The Pros — The Latest In Upstream HCP Mitigation
- 2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For
- Biosimilar Manufacturing Complexity Demands Mastery, Not Mimicry
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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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.
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Moving Leukopaks From GTP To GMP Is One Cell Therapy Trend To Watch In '26
Cell therapy stumbled in 2025. Solving the variability in starting material quality is critical to stabilizing manufacturing in 2026.
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Metrics, Not Audits, Should Lead Vendor Accountability
Episodic vendor audits are better suited for high-risk areas. An oversight system, based on a hierarchy of metrics, provides greater value.
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Ask The Pros — The Latest In Upstream HCP Mitigation
We asked leading experts how upstream interventions can reshape HCP control. Here’s what they shared. Answers have been edited for clarity.
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2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For
2026 is shaping up to be a year in which operational discipline, strategic alignment, and regulatory preparedness will differentiate high-performing sponsors from those facing avoidable delays.
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Biosimilar Manufacturing Complexity Demands Mastery, Not Mimicry
GlycoNex's denosumab biosimilar development experience illustrates how a "just copy it" approach is an insufficient strategy in modern biomanufacturing.
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A Deeper Look At Pharma's Structural Supply Chain Vulnerability
Fixing limited capacity in pharmaceutical CMC development starts with understanding a complex web of root causes.
BIOPROCESSING WHITE PAPERS
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Performance Of HEKima™ Adherent HEK Cell Medium
Explore the performance of a serum-free medium designed for HEK-293 cells, comparing its efficacy to traditional media for protein expression and cell proliferation.
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Accelerating ADC Clinical Development Timelines8/28/2024
For ADC developers, obtaining the desired payload can be a challenge, as their synthesis is more complex than most other small molecules. Learn about a more efficient approach to payload synthesis.
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Advancing A LNP Formulation To Clinical And Commercial Manufacturing3/25/2024
Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
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Building A Legacy In Sterile Injectables Through Strong CMO Synergy5/7/2025
Examine how a CMO can deliver significant value to drug developers by fostering successful outsourcing relationships, streamlining the path to market, and supporting demands.
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Five Essentials For Accurate Oligonucleotide Chemistry3/4/2024
Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.
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CHO Cell Lines For Recombinant Protein Production6/2/2025
Discover how new strategies in CHO cell line development are driving innovation and transforming the future of biologics manufacturing, from enhanced productivity to improved therapeutic quality.
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
- Sterile Filling Readiness In The Drug Device Delivery Ecosystem
- Collaborate For Standardization In Large-Volume Subcutaneous Delivery
- Pfast Protein Expression: A Rapid, Robust Solution For Accelerating Antibody Screening
- Compliance In Conversation: A Fill And Finish Regulatory Roundtable
- Boost Process Efficiency With Our New mAb Optimized TFF Cassette
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 01.16.26 -- STREAM Edition: Why Biopharma's Tech Adoption Seems Slow
- 01.16.26 -- Biosimilar Manufacturing Complexity Demands Mastery, Not Mimicry
- 01.15.26 -- Single-Use Standards Are Maturing, But The Process Remains King
- 01.14.26 -- LSC Editors' Roundtable: Wrapping Up 2025 And Looking Ahead
- 01.13.26 -- 2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For