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

FEATURED EDITORIAL

The External Partners Delivering The Components Of RNA Therapies

“RNA-based therapeutics” is now a diverse and wide field of application; outsourcing the components of these programs is challenging. Executives at the Society For RNA Therapeutics (SRT) say assembling an entire supply chain can soak up time and resources. Which partners to select depends on what area of RNA development you are pursuing. A fundamental task before all RNA sponsors is thinking deeply in terms of assembling development and manufacturing ecosystems, starting at the earliest stages of research and company formation.

GUEST COLUMNISTS

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.
ADC CDMO Selection For Small Biotech
Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.
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.
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.
Rebuilding America's Pharmaceutical Backbone Through Small-Batch Manufacturing
Many small molecule products no longer require massive production. Instead, flexible capacity is needed that can economically produce smaller commercial volumes while maintaining quality and compliance.
CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers
Make smarter outsourcing decisions early. Reduce the risk of costly tech transfers, evaluate capacity needs, speed development timelines, and strengthen manufacturing partnerships.

PHARMA OUTSOURCING WHITE PAPERS

Mastering Modern Challenges In Drug Development Through Expert Technology Transfer
Drawing on experience from hundreds of successful transfers, our experts recognize that informed decision-making at critical junctures can determine whether a program maintains momentum or loses it.

Advancing ADCs With Expertise In Payloads And Linkers
Discover how integrated containment, high-potency expertise, advanced chromatography, and proven linker–payload process optimization can accelerate your ADC program from early development to reliable commercial supply.
Modern Modeling Tools For Small Molecule Solid Dose Manufacturing
Data-driven modeling techniques can enhance scale-up processes, streamline production, and help companies navigate the complexities of modern drug development with greater precision and reliability.
Application Of Plant And Process Models
Explore innovative process and facility models that optimize efficiency, sustainability, and cost-effectiveness in biopharmaceutical manufacturing.
Random And Semi-Targeted Integration In Cell Line Development
While semi-targeted approaches may offer precision, uncover how they may fall short in overall efficiency and productivity, especially in late-stage manufacturing.
Science With Purpose: Advancing Sustainability In Biopharma Testing
Learn how biopharma labs are cutting animal use, energy, and paper waste while maintaining GMP compliance — with specific data on 85% labor reductions and 1 ton of CO2e saved annually.