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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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EDITOR'S DESK

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.

On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing

Takeda head of process development, Amy Shaw, explains what factors to consider when scaling up or scaling out cell therapy manufacturing.

GUEST COLUMNISTS

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.
Survey: SUS Insufficient For 40% Of Biopharma
New data from BioPlan Associates suggests single-use systems adoption may be plateauing with single-digit growth rates.
Allogeneic Cell Therapy's Success Hinges On Perfecting The Platform
The industry remains far from realizing a manufacturing platform with a repeatable, standardized process that can support broad clinical and commercial deployment.
CGT Industrialization Starts With CDMO Alignment
Fragmented processes are stalling progress. By aligning CDMOs through transparency and standards, developers can move past the COGS obsession and stabilize the supply chain.
Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis
Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.
November 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.
Contamination Control Strategies In Low Bioburden Biologic Drug Substance Manufacturing
How do manufacturers apply a contamination control strategy in a non-sterile world, particularly at a low bioburden biologic drug substance manufacturing site? How can Annex 1 apply?
What 2025 FDA Warning Letters Tell Us About GMP Compliance
This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

BIOPROCESSING WHITE PAPERS

Single-Use Technology And Environmental Responsibility In Biopharmaceuticals
Learn about strategies such as regional manufacturing and advanced single-use systems and their potential to minimize carbon footprint and enhance sustainable biomanufacturing.

Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators
4/28/2025

Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.
If You Can't Win The Game, Change It
12/11/2024

Explore how eData sharing is used in the biopharma market, enabling standardized, collaborative supply chains that reduce risks and enhance visibility while improving capacity planning.
Single-Use Innovation For The Future Of Therapeutic Manufacturing
1/28/2025

Gain insight into these end-to-end plasmid DNA solutions, leveraging robust cGMP-compliant processes and single-use manufacturing platforms to accelerate your cell and gene therapy programs.
How To Adopt CSA For Streamlined Computer System Validation
7/1/2025

Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.
Cell Line Development For Bispecific Antibodies
8/18/2025

See how the recently described cell line development paradigm shift, enabled by the Leap-In transposon platform, can extend to the development of bispecific monoclonal antibody-producing cell substrates.

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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.