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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.

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EDITOR'S DESK

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.

On The Ground At BPI: Industry Reflections With Carl Schoellhammer, Ph.D.

DeciBio partner Carl Schoellhammer, Ph.D., speaks on the record with Bioprocess Online's chief editor Tyler Menichiello at the 2025 BioProcess International conference in Boston.

GUEST COLUMNISTS

Unpacking The EU's Mutual Recognition Agreements For Pharma
MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.
The Module Type Package Wants All Your Equipment To Start Talking
A forthcoming ISPE guide uses case studies to aid in the design of plug-and-play process skids with implications for every step in the manufacturing process continuum.
Four Reasons You Should Choose Lyophilization for Your Next Project
Lyophilization ensures product stability, extends shelf life, supports sensitive formulations, and simplifies storage and transport, making it a critical choice for modern drug development projects.
Why Your MVP And Its Evolution Matters To Manufacturing
Minimum viable product is one of the most important inputs to developing a manufacturing process. It defines essentials that matter to the people who make the product.
TFF Offers Ideal Anaerobic, GMP Conditions For LBP Concentration
When configured correctly, TFF provides the gentle processing environment and oxygen protection required for strict anaerobes.
Biotech Wasn't Ready For AI's Speed; Here's How We Catch Up
Computational success is no stand-in for therapeutic readiness. Innovators must learn to discern between models rooted in science and those that speculate.
Strained Manufacturing, Complexity Stymie In Vivo Progress
Explicitly mapping delivery challenges to the associated GMP process steps converts biological risk into operational risk.
To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem
The choice of delivery dictates the complexity of manufacturing, which in turn determines the eventual cost and accessibility of the therapy.

BIOPROCESSING WHITE PAPERS

The Evolution Of EAM/CMMS In Pharma Manufacturing
Explore pharma’s shift from paper-based maintenance to modern EAM/CMMS that shows how digital tools boost compliance, reduce downtime, and improve data accuracy and productivity.

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.
Establishing Commercial Manufacturing Services For ADCs
6/3/2024

Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.
Three Steps To Digital Transformation In Life Sciences Manufacturing
1/30/2025

Explore trends that are transforming the industry, some common speedbumps on the road to innovation, and how a new platform offers unprecedented process transparency and continuous improvement.
Factors To Consider While Selecting Stoppers For Lyophilized Vials
10/16/2024

Ensure the success and stability of your lyophilized products by choosing the right container-closure system — explore your stopper options, here.
Simplifying The Transition To Multi-Column Chromatography
4/5/2024

Explore the advantages of multi-column chromatography and how to transfer your process from batch to an intensified system, step-by-step.

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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.