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August 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

Preserving Tacit Knowledge In ADC Tech Transfers
ADCs built on proprietary platforms risk losing process-specific knowledge during a tech transfer. See what advice panelists from the Bioprocess Online Live event "Ensuring Successful Technology Transfer In ADC Development" shared with the audience on preserving this implicit knowledge.

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.

GUEST COLUMNISTS

Building Sustainable Biopharma Supply Chains Starts With Procurement
Nearly all the industry's emissions happen upstream from core manufacturing functions. This puts sustainability almost entirely on the shoulders of purchasing.
Sustainable Facility Design Brings Bayer Instant Savings
ROI for sustainability initiatives often come later as lower maintenance and utility costs. Bayer's pursuit of LEED certification led to substantial savings up front.
Why You Should Measure Comparability Debt Before Ever Starting A Study
When analytical capability and process understanding fail to keep pace with a drug candidate, the technical uncertainty creates debt that's difficult to pay down.
What FDA Inspectors Want From Your OOS File
Read enough FDA warning letters and a pattern emerges: Investigators rarely cite a retest that was performed badly. They cite a retest that nobody justified in writing. Let's take a closer look.
New USP Guidelines, Standards Address Lentivirus Characterization
The United States Pharmacopeia is rolling out new standards and tools to help manufacturers characterize fragile, complex lentiviral vectors.
You Can't CAPA What You Can't Classify
An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.
6 Modeling Approaches That Make Complex Bioprocess Data Useful
AI algorithms can reduce data dimensionality more faithfully by interpreting multivariate features relevant to prediction or control.
Bringing Next-Gen Sequencing To GMP Scale
NGS enables broad detection of known and novel viruses in a single assay. Its high sensitivity, specificity, and scalability can meet GMP throughput levels.

BIOPROCESSING WHITE PAPERS

Advancing Drug Safety And Improving R&D Productivity With The Liver-Chip S1
Explore how the Emulate Liver-Chip S1 revolutionizes predictive toxicology by mimicking human liver biology, achieving superior sensitivity and specificity.

ICH E6(R3) In Effect: Transforming Quality Management For Cell And Gene Therapy Trials
1/29/2026
Effects Of Sequence Fidelity On Cloning Efficiency
6/15/2026

dsDNA fragments speed up cloning but introduce variability that can affect results. Comparing fragment fidelity, efficiency, and design considerations helps researchers choose the right approach.
Smart Manufacturing For Pharma: Modular Automation And MTP
8/14/2026

Pharma manufacturers average just 35% OEE. Learn how modular automation, MTP, digital twins, and paperless manufacturing close that gap without sacrificing GMP compliance.
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.
Challenges And Solutions In Lyophilization Development For ADCs
12/10/2025

Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.

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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.