Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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.

GUEST COLUMNISTS

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.
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.
AI Fills The Decision-Making Gaps In Process Analytical Technology
When combined, artificial intelligence and PAT help move beyond reactive quality testing to proactive and anticipatory process management.
Is mRNA Manufacturing Overbuilt?
mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.
Using Digital Platforms To Find Your CDMO
In recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.
FDA Issues New Guidance On Therapeutic Equivalence
The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?
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.

PHARMA OUTSOURCING WHITE PAPERS

Accelerating Small Molecule Protein Degrader Development Using High-Content Imaging
High‑content imaging enables rapid discovery and optimization of small‑molecule protein degraders by delivering multiparametric, single‑cell insights that accelerate hit identification, SAR development, and lead advancement.

How To Maximize Pipeline Value And Enhance eNPV
Find out how reducing vendor fragmentation can improve program continuity, minimize delays, and support more predictable development outcomes.
Key Selection Criteria For Cell & Gene Therapy CDMOs
Choosing the right CDMO requires early internal assessment plus strong technical capability, agility, advocacy, clear communication, and long‑term alignment to meet evolving cell and gene therapy needs.
IP Considerations In Drug Development For Biotech Companies
Integrate a strategic intellectual property approach early in drug development to streamline research, uncover opportunities, and maximize the return on your investment.
Continuous Flow — An Emerging Alternative
Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.
Effect of Shelf Cooling Rate on the Nucleation Temperature of Ice Monitored Using Thermocouples and Wireless Temperature Sensors
Freezing conditions shape ice structure, mass transfer resistance, and drying efficiency. Data shows how cooling rate, vial size, and nucleation interact to optimize freeze-drying.