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July 2026 — 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

Multispecific Manufacturability Starts With Molecular Design
AP Biosciences’ VP of antibody discovery, Jhong-Jhe You, Ph.D., explains the key design elements of multispecific antibodies and how they affect product developability.

On The Ground At BIO 2026: Johanna Kaufmann, Ph.D., On The Oncology Modality Puzzle

At the 2026 BIO International Convention, Bioprocess Online caught up with Johanna Kaufmann, Ph.D., CSO at Deck Bio, a company developing multi-targeted T-cell engagers for solid tumors.

BIO 2026: Modernizing The FDA And Bolstering The Workforce

Bioprocess Online's chief editor, Tyler Menichiello, shares his key takeaways from the 2026 BIO International Convention in San Diego.

BIO 2026: Crowley On Competing With China And Modernizing The FDA

Exclusive coverage from John Crowley's press conference at the 2026 BIO International Convention in San Diego.

Essential CMC Elements For A Therapeutic Secretome

Noveome Biotherapeutics's Larry Brown, Sc.D., explains the regulatory and CMC challenges behind the company's novel secretome therapy, ST266.

GUEST COLUMNISTS

Europe's ATMP Opportunity Still Requires Local Navigation
European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.
The Unspoken Truth About Cell Therapy Product Understanding
Developers often discover important attributes after it's too late to act on them. A well-designed program asks what's needed for commercialization and works backward.
Enzyme Activity As A Surrogate Potency Marker In Cell Therapy
When measuring cell therapy potency, biochemical assays can provide a rapid alternative to the time- and material-consuming standard of cell-based assays.
Implementing And Optimizing Your eQMS
This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.
Choosing Analytical Technologies At The Right Stage Of Development
Take a beat before investing in the latest analytical tools. Capability and sensitivity come at a cost. Depending on your phase, you might not need it just yet.
The Complex Anatomy Of An ADC Tech Transfer
Unlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.
What Goes Into Restarting A Shelved Orphan Drug Candidate?
The Orphan Therapeutics Accelerator wants to help viable clinical-phase products reach patients. Its cofounder describes the complexity of rebooting a shelved candidate.
A Much-Improved Approach For Understanding And Managing Safety Risks
Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

BIOPROCESSING WHITE PAPERS

Perspectives On Performance, Scalability, And Regulatory Compliance
Here, we discuss the challenges and solutions for cell and gene therapies, focusing on performance, scalability, and regulatory compliance to accelerate commercialization and improve patient access.

Avoiding The Pitfalls Of APQR
6/9/2026

Traditional quality reviews often fall short in today’s data-heavy environment. A real-time, digital-first approach enables faster insights, stronger compliance, and more proactive quality management.
Overcoming Challenges To High-Concentration Formulation Development
3/25/2025

Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.
Achieve Higher Targeted Concentrations
9/30/2025

Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.
Overcoming Barriers To Membrane Technology: Demonstrating Protein A Affinity Capture Quality, Process Similarity
3/25/2025

Explore how the interchangeable use of Protein A membrane and resin media can streamline your bioprocessing workflows, ensuring efficient, scalable, and high-quality manufacturing from lab scale to full-scale production.
Systematic Strategy To Reduce The Cost Of Goods Sold
3/26/2026

Learn key ways to cut biologics manufacturing costs through smarter process design, material choices, and supply resilience — driving more efficient, reliable, and commercially sustainable production.

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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.