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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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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

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.
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.
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.
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.
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.
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.
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.
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.

BIOPROCESSING WHITE PAPERS

Cell Line Development For Bispecific Antibodies
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.

The Impact Of Artificial Intelligence On CQV
7/23/2025

AI is revolutionizing CQV in life sciences by automating documentation, enabling real-time monitoring, and driving predictive quality to boost efficiency and compliance across validation processes.
The Current And Future Value Of mRNA Vaccines And Therapeutics
5/16/2024

Discover how decades of research have propelled mRNA technology to the forefront of therapeutic development and learn how our expertise is advancing mRNA drug development.
Innovation In Filtration
3/18/2025

Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.
Leveraging 3 Distinct Resins To Provide Effective Impurity Removal For mAbs And Novel Antibody Derivatives
11/3/2025

Due to the complexity of bispecifics, Fc-fusion proteins, and Fab fragments, their manufacturing poses added purification challenges and requires a robust toolkit of purification techniques.
The Effect Of Mixing Homogeneity In Retentate Vessel
8/5/2025

Discover a novel analytical method enhancing TFF diafiltration insights that deliver superior mixing, reliable scale-up, and breakthrough interpretation of diavolume performance.

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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.