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

FEATURED EDITORIAL

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DEA Reveals Hidden Costs Of Analytical Validation Guidelines

By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

GUEST COLUMNISTS

CDMO Selection Beyond Capabilities And Price
Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
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.
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.
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.
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.

PHARMA OUTSOURCING WHITE PAPERS

Developing Effective Procedures
Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

Transitioning Your Product From Phase 1 To Phase 2 Clinical Studies
Strategic partnerships can streamline your transition from Phase 1 to Phase 2 clinical studies, ensuring optimized dosage forms, seamless scale-up, and alignment with patient and study requirements.
Patented Process For Intermediates Useful For Deucravacitinib
Discover how this patented synthetic approach to Deucravacitinib intermediates can improve yield, simplify purification, and support scalable, regulatory-aligned manufacturing.
Tool Enzymes For Antibody-Drug Conjugate Development And Manufacturing
See how modern tool enzymes enable cleaner, more consistent ADC conjugation, sharper analytics, and a smoother path from research to clinical development — practical guidance for manufacturing.
Building Late-Stage Efficiency Into Biologics Development
Building late-stage efficiency early in biologics development prevents scale-up delays. Flexible platforms and risk-based validation streamline technology transfer and lower production costs.
Advanced Methodology Of PLGA-Based Parenteral Formulations
To enable the development of optimized PLGA-based sustained release formulations, this paper offers essential insights into the polymer’s properties, fabrication techniques, and drug release mechanisms.